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Clinical Vendor Activation Manager
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About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com.
How This Role Makes a Difference
The Clinical Vendor Activation Manager serves as a dedicated resource within the Study Start Up Department (SSU) to oversee vendor engagement during clinical trial start-up and execution. This role ensures vendors are qualified, contracted, and aligned with study protocols and activation timelines. The Clinical Vendor Activation Manager combines operational vendor oversight with clinical insight, enabling Care Access to activate studies on time and support the site network effectively.
How You'll Make An Impact
Clinical protocol review and vendor needs identification
- Review clinical protocols and study documents to determine vendor scope and compatibility; translate protocol elements into vendor qualifications and expectations
Clinical consultation for vendor qualification
- Provide clinical insight to the Vendor Management and SSU teams to support vendor selection, feasibility, and site alignment.
- Collaborate with SSU, Regulatory, Site Ops, Legal, Vendor Management, and other departments to align on vendor strategy, timelines, and documentation flow
Vendor onboarding and issue escalation
- Guide vendors through training expectations based on protocol requirements; assist internal teams in clarifying procedural expectations and documentation needs.
- Identify and troubleshoot vendor-related issues impacting clinical execution or study timelines; act as clinical escalation point for vendor readiness concerns
Clinical support during SEV and site activation
- Participate in SEV preparation and vendor-related activation readiness, ensuring clinical requirements are addressed early in the start-up process, with an ‘outside-the-box' mindset to identify creative solutions with sites and managers to meet deliverables
- Serve as the clinical point-of-contact for vendors, ensuring timely responses when study manuals are unavailable.
- Standardize and improve communication pathways between vendors, SSU teams, and internal stakeholders.
- Monitor vendor performance, proactively raise risks based on historical knowledge, and escalate concerns impacting KPIs.
- Document and track contracting and qualification timelines, escalation history, and vendor performance metrics in internal systems
- Support relationship-building with vendors, sponsors, site networks, and investigators by ensuring consistent, high-quality messaging.
- Develop and refine vendor management processes to optimize efficiency and quality.
- Contribute to pipeline planning by maintaining accurate vendor historical records and lessons learned.
- Apply data management skills to track KPIs and ensure compliance with site network requirements.
- Negotiate with vendors and sponsors, demonstrating sales ability when communicating the benefits of partnering with Care Access.
- Maintain vendor documentation, records of communications, and escalation logs.
- Represent Vendor Management in clinical and operational discussions with sponsors, CROs, and vendor teams.
- Guide internal and external stakeholders on vendor requirements, protocol expectations, training, and procedures.
- Participate in governance calls and internal meetings to provide updates on vendor performance and risk status.
- Develop tools, templates, and training materials to strengthen vendor onboarding and oversight processes.
- Oversee vendor relationships, ensuring compliance with company policies, service level agreements, and performance standards.
- Review, negotiate, and manage contracts throughout their lifecycle, including renewals and amendments.
- Monitor vendor performance, resolve escalations, and recommend improvements to optimize cost, quality, and service.
The Expertise Required
Knowledge, Skills, and Abilities:
- Strong understanding of clinical protocols, trial execution, and start-up workflows.
- Prior vendor experience with the ability to discuss protocol clinical aspects with vendors.
- Skilled at guiding vendor partners and internal teams on protocol expectations, training, and procedures.
- Effective communicator of vendor requirements both internally and externally.
- Experience interacting with sponsors and their preferred vendor teams to review expectations and qualifications.
- Experience working with site networks; direct site-based experience strongly valued.
- Ability to negotiate and 'sell' Care Access’s value to vendor partners and sponsors.
- Experience interacting with investigators, clinical staff, and site teams to support operational decision-making.
- Strong cross-functional communication skills in a fast-paced, matrixed environment.
- Creative, outside-the-box problem solving with openness to brainstorming solutions.
- Proactive mindset with ownership, accountability, and focus on clinical quality.
- Ability to foresee risks based on historical knowledge, manage escalations efficiently, and follow up across governance structures.
- Data management skills for tracking KPIs, vendor performance, and escalation logs.
- Ability to hold vendors accountable to agreed timelines and deliverables.
- Capacity to effectively document historical vendor performance and leverage it for future pipeline planning.
- Experience creating and implementing new processes based on role and company needs.
- Experience reviewing, interpreting, and providing feedback on vendor contracts, including identifying risks, obligations, and compliance requirements.
- Proven ability to manage the full lifecycle of vendor contracts, from negotiation through execution, renewal, and termination.
Certifications/Licenses, Education, and Experience
- Bachelor’s degree in life sciences, healthcare, nursing, or related field (advanced degree preferred).
- 3–5 years of experience in clinical operations, vendor management, or clinical trial start-up.
- Prior vendor-facing experience within clinical trials required.
- Familiarity with vendor qualification systems, contracting workflows, and site activation processes.
- Experience in SSU, Clinical Project Management, or Vendor Oversight strongly preferred.
- Proficiency with CTMS, clinical portals, and project tracking tools.
How We Work Together
- Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
- Travel: This is a remote position with less than 20% travel requirements. Occasional planned travel may be required as part of the role.
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected salary range for this role is $80,000- $100,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
Ready to apply?
Apply to Care Access
CTMS Operations Analyst
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About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com.
How This Role Makes a Difference
The CTMS Operations Analyst executes CTMS site and study build configuration, performs build quality control, provides technical support to Care Access users, and produces CTMS-sourced operational reporting to enable final build acceptance and platform governance. The Analyst prepares work for CTMS Operations Manager review, triages incidents, maintains runbook artifacts, and drives first-pass build quality. This role supports the CTMS Operations Manager’s responsibilities for platform governance, release/change-control, vendor coordination, and enterprise reporting
How You'll Make An Impact
- Populate CTMS entries (visits, procedures, schedules, financial elements, site personnel) according to company requirement; prepare and hand off builds to the CTMS Operations Manager for final review/acceptance.
- Execute build QC checklists, validate configuration and data, log defects with reproducible steps, remediate where possible, and escalate gating defects to the Manager or vendor. Track first-pass acceptance and defect remediation metrics.
- Provide day-to-day CTMS technical support for Study Start-Up (SSU), Source, Study Ops, Site Network and other Care Access users (access requests, role/tag maintenance, runbook guidance); deliver study-specific CTMS training as assigned.
- Produce standard CTMS reports and operational dashboards used by SSU/Study Ops; perform ad-hoc data pulls to support study readiness and cross-functional decision-making
- Maintain build checklists, runbooks, and training materials; propose process improvements that reduce rework and improve build quality and throughput.
- Maintain build checklists, runbooks, and training materials; propose process improvements that reduce rework and improve build quality and throughput.
- Maintain accurate build documentation and audit trails for study readiness and compliance.
- Support the CTMS Operations Manager in vendor ticketing and incident tracking when escalated.
- Assist with onboarding and training of new CTMS Analysts and temporary staff.
The Expertise Required
- Working knowledge of CTMS configuration and study-build processes (experience with Conductor, Florence, Veeva, or comparable CTMS preferred).
- Strong attention to detail and experience executing QC/checklist work.
- Ability to run and interpret CTMS exports/queries and translate results for non-technical stakeholders.
- Practical experience creating operational reports and dashboards (Conductor, Excel, BI tools).
- Effective written and verbal communication for user support and cross-functional coordination.
- Familiarity with ICH-GCP, SOPs, and audit processes.
Certifications/Licenses, Education, and Experience:
- Bachelor’s degree preferred (or equivalent experience).
- 2-4 years of CTMS/platform or clinical systems experience, with 1+ years directly supporting CTMS, study builds, or clinical data operations.
- Preferred certifications: CTMS platform/certification training, GCP/clinical research certifications, or relevant technical certifications.
How We Work Together
- Location: Remote within Poland
- Travel: Minimal (<10%), planned in advance.
Benefits & Perks
- Paid Time Off (PTO) and Company Paid Holidays
- Medical, dental, and vision insurance plan options
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
Ready to apply?
Apply to Care Access
CTMS Operations Analyst
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About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com.
How This Role Makes a Difference
The CTMS Operations Analyst executes CTMS site and study build configuration, performs build quality control, provides technical support to Care Access users, and produces CTMS-sourced operational reporting to enable final build acceptance and platform governance. The Analyst prepares work for CTMS Operations Manager review, triages incidents, maintains runbook artifacts, and drives first-pass build quality. This role supports the CTMS Operations Manager’s responsibilities for platform governance, release/change-control, vendor coordination, and enterprise reporting
How You'll Make An Impact
- Populate CTMS entries (visits, procedures, schedules, financial elements, site personnel) according to company requirement; prepare and hand off builds to the CTMS Operations Manager for final review/acceptance.
- Execute build QC checklists, validate configuration and data, log defects with reproducible steps, remediate where possible, and escalate gating defects to the Manager or vendor. Track first-pass acceptance and defect remediation metrics.
- Provide day-to-day CTMS technical support for Study Start-Up (SSU), Source, Study Ops, Site Network and other Care Access users (access requests, role/tag maintenance, runbook guidance); deliver study-specific CTMS training as assigned.
- Produce standard CTMS reports and operational dashboards used by SSU/Study Ops; perform ad-hoc data pulls to support study readiness and cross-functional decision-making
- Maintain build checklists, runbooks, and training materials; propose process improvements that reduce rework and improve build quality and throughput.
- Maintain build checklists, runbooks, and training materials; propose process improvements that reduce rework and improve build quality and throughput.
- Maintain accurate build documentation and audit trails for study readiness and compliance.
- Support the CTMS Operations Manager in vendor ticketing and incident tracking when escalated.
- Assist with onboarding and training of new CTMS Analysts and temporary staff.
The Expertise Required
- Working knowledge of CTMS configuration and study-build processes (experience with Conductor, Florence, Veeva, or comparable CTMS preferred).
- Strong attention to detail and experience executing QC/checklist work.
- Ability to run and interpret CTMS exports/queries and translate results for non-technical stakeholders.
- Practical experience creating operational reports and dashboards (Conductor, Excel, BI tools).
- Effective written and verbal communication for user support and cross-functional coordination.
- Familiarity with ICH-GCP, SOPs, and audit processes.
Certifications/Licenses, Education, and Experience:
- Bachelor’s degree preferred (or equivalent experience).
- 2-4 years of CTMS/platform or clinical systems experience, with 1+ years directly supporting CTMS, study builds, or clinical data operations.
- Preferred certifications: CTMS platform/certification training, GCP/clinical research certifications, or relevant technical certifications.
How We Work Together
- Location: Remote within Brazil
- Travel: Minimal (<10%), planned in advance.
Benefits & Perks
- Paid Time Off (PTO) and Company Paid Holidays
- Medical, dental, and vision insurance plan options
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
Ready to apply?
Apply to Care Access
Study Start Up Manager
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About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com.
How This Role Makes a Difference
Care Access Study Start Up Managers play a critical role in facilitating the start-up activities needed to select and activate studies at sites within Care Access. This role supports the selection and start-up process for our sites by leading cross-functional groups across the global organization to complete successful pre-site visits and accelerate site activation. This role will follow the Care Access study start-up processes in accordance with industry regulations, Care Access SOPs, and study-specific requirements.
How You'll Make An Impact
- Collect and interpret information from the Protocol, business development sold strategy & site feasibility team to prepare the site staff for site evaluation visits
- Oversee the execution of Site Activation, site activation strategy, adhering to project timelines. Develop, implement, and maintain the Management Plan according to the Scope of Work and Project Plan.
- Lead the process of study start-up to support site evaluation/selection visits on each new study and help get selected sites successfully activated and ready to consent
- Support the site through the Site Evaluation Visit, Site Initiation Visit, and greenlight to consent
- Collect and interpret information from the Protocol & Site Feasibility team to help prepare the sites and site staff that have been chosen for site evaluation visits
- Collect and review study activation requirements, understand startup timelines, key contacts & performance expectations
- Manage communications and expectations with client (Sponsor and/or CRO)
- Provide overall guidance and oversight of programs during initial start-up phase as an integral member of the study start-up team.
- Manage communications and expectations with site staff
- Support sites through their evaluation and begin start-up activities upon selection
- Work closely with the staff onsite to help address their remaining questions about the study
- Ensure that any and all information gained during the start-up process is completely transitioned to sites and other central teams, as required
- Partner with other Care Access teams to initiate other Study related processes at the appropriate SSU milestone (e.g. capacity planning, systems build requests, etc)
- Liaise with internal key stakeholders across the organization to establish timelines and needs
- Liaise with key stakeholders across the global organization to communicate needs and establish start-up timelines
- Both drive & support Care Access sites throughout the activation process, ensuring risk assessment, mitigation support and start up success
- Assist with triggering internal departments- such as (but not limited to) source, vendor management, operational compliance, etc.
- Manage vendor requirements
- Start up escalation & mitigation
- Track and report on forecasted and actual SSU submission and approval timelines
The Expertise Required
- Expert knowledge of general clinical research processes and Good Clinical Practice
- Excellent written and verbal communication skills
- High level of professionalism and confidentiality required
- Excellent interpersonal skills
- Ability to manage against tight timelines and competing priorities
- Strong judgment and ability to make evidence based decisions
- Proficient with Microsoft Office Suite
- Ability to work collaboratively across departments
- Excellent project and process management skills; ability to prioritize in a fast-paced work environment, pivot quickly based on changing business needs, and manage time appropriately
- Ability to build relationships effectively in a geographically dispersed, largely remote environment
- Ability to independently coordinate and manage new processes
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Minimum 3+ years clinical research experience with at least 1 year of relevant experience completing study start-up activities at a site
- Bachelor’s degree in life sciences or equivalent is preferred (6-10 years of experience in lieu of degree)
How We Work Together
- Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
- Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected salary range for this role is $90,000 - $100,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
Ready to apply?
Apply to Care Access
Site Support Solutions Manager
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About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com.
How This Role Makes a Difference
SSS Manager LATAM position hires, develops, enables, and engages their team in Site Support Solutions to ensure an elevated level of performance and exceptional customer experience. The manager will provide daily support to all SSS team members to drive study results and help in the complexities of study operations. Responsibilities include collaborating with sponsor teams, Care Access leadership, and other teams as required to deliver study results. This role is responsible for determining the key priorities and goals in partnership with sponsor leadership and Care Access leadership, then translating these priorities into actionable goals and activities for their SSS team members. Managers must ensure that the team has appropriate resources and expertise to deliver those goals. This is a managerial level role with the expectation that the manager has strong working knowledge of and experience in the clinical research industry, especially in the LATAM region.
How You'll Make An Impact
- Understand and manage all aspects of the day-to-day work of SSS team.
- Interview, hire, onboard, and train new SSS professionals into the team.
- Point of contact with our staffing partners to align on staffing needs or requirements for any positions to be filled.
- Understand LATAM recruitment trends, vendors, and technologies to support team growth.
- Set clear and actionable goals for the team and support them to deliver to expectations.
- Review KPIs and provide coaching to SSS to ensure they are meeting standard metrics.
- Facilitate team meetings.
- Balance workload and responsibilities within team as priorities and team structure change and evolve, assess team utilization regularly.
- Take corrective action and provide feedback when the performance of the team or individuals within the team do not meet expectations.
- Keep leadership updated with important updates regarding the team, performance, and other key information and escalations.
- Weekly presentation to Sponsor on team progress and performance.
- Serve as point of escalation for site-based issues.
- Develop partnerships with sites, clients, and other study teams to create an environment of collaboration and progress.
- Hold team accountable for conducting their work in accordance with GCP and provide guidance and training on GCP as needed.
- Proactively solve problems and identify opportunities for process improvement.
- Analyze and understand study protocols.
- Additional duties/responsibilities may be assigned as needed.
The Expertise Required
- Leadership skills and a desire to manage people.
- Demonstrate professionalism in all situations and work effectively with a diverse group of individuals.
- Proficient with Microsoft Office applications (Word, Outlook, Teams, and Excel).
- Ability to establish and maintain effective working relationships.
- Ability and willingness to work independently with minimal supervision.
- Ability to learn to work in a fast-paced environment.
- Excellent organizational skills with strong attention to detail.
- Critical thinker and problem solver.
- Proficient in research terminology and basic medical terminology.
- Understand the overall clinical development paradigm and excellent working knowledge of government regulations, GCP, and ALCOA-C. This applies particularly in all LATAM regions.
- Strong organization and time management skills.
- Ability to work effectively in a remote environment.
- Proper home office set-up including private space for participant communication and high-speed internet.
- Bachelor’s degree in a science related field or the equivalent experience
- At least six years of relevant clinical research experience
- At least two years of experience leading teams
- Fluency in Portuguese and Spanish, fluency English is a bonus.
How We Work Together
- Location: Remote within Brazil. This role requires 100% of work to be performed in a remote office environment.
- Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
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Senior Specialist, Regulatory Operations
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About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com.
How This Role Makes a Difference
Care Access is seeking a skilled and experienced Senior Specialist, Regulatory Operations to join our dynamic Global Regulatory Operations Team, part of the Global Expansion and Study Operations department.
The Senior Specialist, Regulatory Operations will oversee, support, and execute all site-level regulatory operational activities for assigned clinical trials in the U.S. They may also support regulatory activities for Canadian sites as needed. This role is responsible for ensuring compliance with applicable U.S. regulations and guidelines and may contribute to site start-up activities for U.S. sites when required.
You will have an excellent understanding of U.S. regulatory requirements and experience managing regulatory interactions and activities related to clinical research site operations.
How You'll Make An Impact
- Provide regulatory advice, lead, execute and deliver regulatory project work
- Support regulatory compliance activities for U.S. clinical research sites, ensuring to adherence to FDA, OHRP and global regulatory standards.
- Assist in preparing for sponsor monitoring visits and follow up requirements.
- Develop and implement regulatory strategies to support sites activities
- Provide regulatory guidance to the site operations teams, ensuring that activities align with current regulations and industry best practices.
- Coordinates preparation and review of key site essential records.
- Track essential records and timelines
- Support the site(s) through the Site Evaluation Visit, Site Initiation Visit, greenlight to consent, and Study Closeout.
- Actively work towards KPIs to help ensure departmental success
- Supports creation and maintenance of study Delegation of Authority (DOA) logs
- Support regulatory activities throughout the duration of the study lifecycle; collaborating with clinical operations teams to ensure regulatory compliance
- Coordinate and perform IRB site level submissions and maintenance of approvals throughout the life of the study/ies.
- Review, and submit high-quality and timely IRB submission materials, including but not limited to protocols, ICFs and marketing materials.
- Reviews and customize, when required, ICFs to ensure compliance with U.S. IRB requirements and site feedback.
- Liaise and follow up directly with Sponsor.
- Ensures accurate compilation, management and tracking of submissions.
- Oversee regulatory documentation, tracking, and reporting processes to maintain compliance and readiness for regulatory inspections and sponsor audits.
- Milestones: Tracks and updates the study team accordingly.
- Ensure timely filing of safety reports, deviations, and amendments/modifications as per study requirements.
- Ensures that Investigator Site File (ISFs) are completed, up to date, accurate and in compliance with Good Clinical Practice (GCP), regulatory requirements and internal processes.
- Oversee and support study close-out activities by ensuring proper archiving and retention of ISF documents.
- Provides guidance and support to site staff with regards to regulatory intelligence and country requirements, including identifying and conducting training.
- Collaborate with cross-functional teams, including Quality and Clinical Operations, to ensure regulatory requirements are met.
- Monitor and interpret changes in U.S. regulatory policies and guidelines, advising internal stakeholder on potential impacts.
- Stay updated on evolving regulations, guidelines, and industry best practices to ensure compliance and adjust strategies.
- Identify process gaps, and support the development, implementation, and continuous improvement of new departmental processes.
- Support the development, review, and maintenance of departmental Standard Operating Procedures (SOPs), work instructions, and forms
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
The Expertise Required
- Ability to communicate and work effectively with a diverse team of professionals
- Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers, management, clients, and vendors
- Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals
- Strong computer skills with demonstrated abilities using clinical trials database, MS word and excel
- Experience in electronics Investigator Site Files systems like (Florence, CRIO)
- Ability to balance tasks with competing priorities
- Curiosity and passion to learn, innovate, able to take thoughtful risks and get things done
- Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
- High level of self-motivation and energy
- Ability to work independently in a fast-paced environment with supervision
- Must have a client service mentality
- Demonstrated success in managing IRB and regulatory submissions, including FDA interactions.
- Detail-oriented with strong problem-solving abilities and a proactive approach to regulatory challenges.
- Excellent ability to handle multiple tasks in a fast-paced and constantly changing environment.
- Strong strategic planning, risk management, managing, monitoring and change management skills.
Certifications/Licenses, Education, and Experience
- Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred or equivalent experience.
- Minimum of 4 years of experience in operational regulatory affairs within the research site (preferable), or CRO/pharmaceutical industry, with a focus on U.S. regulatory requirements.
- Strong understanding of U.S. regulations and ICH GCP guideline as they relate to site operations
- Excellent knowledge of site-level regulatory requirements for the execution and maintenance of clinical trials in the U.S.
- Proven ability to support sites in IRB submissions, regulatory document preparation, and ongoing compliance.
How We Work Together
- Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
- Travel: This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected salary range for this role is $90,000 - $120,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
Ready to apply?
Apply to Care Access
Director/Senior Director, Site Excellence
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About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com.
How This Role Makes a Difference
The Director/Senior Director, Site Excellence is a senior leadership role accountable for the strategy, design, build-out, and delivery of operating models supporting specialized, non-traditional, and partner-operated clinical research sites across the United States.
This role is intentionally designed for a leader who can operate at both altitude and ground level—setting strategy, defining governance, and building scalable frameworks, while also remaining deeply hands-on in execution, problem-solving, and site engagement. The portfolio requires differentiated management outside the traditional site network due to its unique operational, regulatory, and partnership nuances.
The role demands a leader who can build processes, translate site-level realities into enterprise processes, and personally drive outcomes during periods of growth, complexity, and change.
How You'll Make An Impact
- Strategic Leadership & Portfolio Oversight
- Own the end-to-end strategy, operating model, and performance of US-based specialized and franchise clinical research sites.
- Identify opportunities to scale, optimize, or replicate successful site and franchise models.
- Hands-On Execution & Delivery
- Serve as the primary owner for building and operationalizing processes across site startup, enrolment, performance management, quality oversight, and partner engagement.
- Engage directly with sites and partners to assess operations, diagnose issues, and drive rapid resolution.
- Lead critical initiatives personally until they are stable, scalable, and ready for delegation.
- Act as the senior escalation point for complex operational, regulatory, and partner challenges.
- Operational Excellence & Scalability
- Oversee site startup, onboarding, and integration for new specialty site models.
- Build and embed operational excellence frameworks informed by best practices from high-performing sites.
- Establish KPIs, dashboards, and review cadences to monitor performance across quality, enrolment, timelines, cost, and patient experience.
- Drive continuous improvement initiatives to enhance efficiency, scalability, and operational resilience.
- Partner & Stakeholder Leadership
- Serve as the executive owner for partner site relationships, ensuring alignment with quality standards, brand expectations, and contractual obligations.
- Lead senior-level engagement with sponsors, CROs, and internal stakeholders tied to partner and specialized sites.
- Translate protocol, sponsor, and regulatory requirements into practical, scalable guidance for site execution.
- Quality, Compliance & Risk Ownership
- Ensure all sites operate in compliance with GCP, FDA regulations, IRB requirements, and applicable state and federal laws.
- Partner with Quality, Compliance, and Legal teams to proactively identify and mitigate operational and regulatory risks.
- Oversee audit readiness, inspection outcomes, and corrective/preventive action plans across the portfolio.
- Financial & Business Accountability
- Own P&L performance for specialized and partner site operations.
- Partner with Finance to build budgets, forecasts etc.
- Identify opportunities for sustainable growth, margin improvement, and cost optimization.
- Team Leadership & Capability Building
- Build and lead a high-performing leadership team responsible for site operations and operational excellence.
- Establish role clarity, decision rights, and performance expectations across the organization.
- Coach leaders to move from reactive site support to proactive, scalable execution.
- Maintain personal ownership of critical workstreams while building long-term organizational capability.
The Expertise Required
- Demonstrated success building and scaling non-traditional, partner-led, or complex site operating models.
- Proven ability to operate as both strategist and hands-on operator in high-growth or ambiguous environments.
- Deep understanding of site-level execution: startup, enrolment, regulatory processes, sponsor engagement, and remediation.
- Strong working knowledge of FDA regulations, GCP, and clinical trial operations.
- P&L ownership experience across multi-site portfolios.
- Exceptional executive communication, influence, and change-management skills.
- Preferred:
- Experience standing up sites or operational excellence functions.
- Background in decentralized or innovative clinical trial delivery models.
- Experience operating in matrixed, global organizations.
- Bachelor’s degree required; advanced degree (MBA, MPH, MS, or similar) strongly preferred.
- 12–15+ years of progressive leadership experience in clinical research operations, site management, or healthcare services.
How We Work Together
- Location: Remote within the United States. This role requires 100% of work to be performed in a remote office environment.
- Travel: This role requires up to 70% travel within the United States. Length of travel will depend upon study requirements, staff needs, and company initiatives.
- Type of travel required: National
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected base salary range for this role is $130,000 - $190,000 USD per year for full time team members. In addition to base salary, this role is eligible for an annual discretionary bonus as part of its overall cash compensation.
Benefits & Perks (US Full Time Employees)
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
Ready to apply?
Apply to Care Access