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

The Central Study Coordinator – Retention (CSC-R) position combines clinical research and patient education skills into a singular role that delivers a strong customer experience for participants of patient programs, primarily the Future of Medicine program. The CSC-R acts as a virtual partner to individuals participating in the program and who are interested in learning more about clinical research. The CSC-R is accountable for ensuring the participants of the Future of Medicine are properly educated, retained, and considered for study participation. CSC-Rs do this several ways including but not limited to sharing and explaining lab results, conducting virtual consenting appointments, and pre-screening participants for specific studies. This role is expected to coordinate daily work independently using patient centric practices and a quality-first approach. This is a mid-level individual contributor role with the expectation that the CSC-R has strong working knowledge of and experience in the clinical research industry and excellent interpersonal skills.   

How You'll Make An Impact

• Manage retention work for each assigned participant to deliver the highest quality customer experience within required program timelines 
• Build strong rapport with participants within a virtual environment to help retain and engage them for future clinical studies 
• Prepare participants to participate in clinical studies through education using provided educational materials  
• Understand when a participant requires more or less engagement and tailor their retention experience accordingly  
• Connect participants with study sites when sites have a study for which the participant may qualify  
• Organize and share lab and other test results with internal staff including PIs and recruitment team  
• Understand when to escalate lab and other test results to physicians for review and correctly follow program guides, SOPs, and other written instruction regarding health related escalations 
• Manage and update participant retention activity in a dedicated tech management system in real time  
• Work effectively with other CSC-Rs, physicians, and sites 
• Review and give input in the development of education materials for the retention program  
• Identify and implement new ways of retaining and engaging potential study participants  
• Schedule, prepare for, and facilitate participant calls in accordance with the program guidelines 
• Analyze and understand study protocols in order to help match potential participants to them 
• Additional duties and responsibilities may be assigned as needed  

The Expertise Required

• Demonstrate professionalism in all situations and work effectively with a diverse group of individuals   
• Understand when issues require escalation  
• 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  
• Strong organization and time management skills  
• High attention to detail  
• Effective communication over phone (proper speaking volume, clarity, speech cadence) 
• Excellent customer service skills 
• Warm, personable approach in communicating with others both verbally and in writing 
• Ability to communicate the basics of clinical research related to patient education 
• Ability to work effectively in a remote environment within minimal supervision 
• In the event of potential work from home, proper home office set-up including a private space for participant communication and high-speed internet (at minimum: 100MB up and 15 MB down, 5 GHz router)  

 Certifications/Licenses, Education, and Experience:    

• Fluent in Portuguese, Spanish and/or English is a bonus 
• At least 6 months of relevant clinical research experience  
• Experience working on high volume screening studies 
• Experience with patient education and retention 

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

The Source Document Specialist is responsible for ensuring accurate, compliant, and efficient clinical trial documentation. This role translates complex study protocols into clear, structured source documents that support high‑quality data collection and regulatory compliance. Serving as a key partner to site staff and study teams, the Specialist manages version control, improves documentation workflows, and safeguards data integrity. This position supports global clinical research operations, including collaboration with Brazil‑based sites and international teams, and requires regular engagement with global stakeholders and English‑language clinical documentation.

How You'll Make An Impact

• Prepare and develop accurate source documents (eSource and paper) based on clinical trial protocols, ensuring compliance with GCP, 21 CFR Part 11, and internal SOPs.
• Review and validate source documents to ensure completeness, accuracy, and alignment with study protocols, coordinating with site staff and internal teams for feedback and approval.
• Maintain version control, track document updates, and implement protocol amendments efficiently while ensuring compliance with regulatory requirements.
• Manage daily communication with site staff, study teams, and internal departments regarding source document updates, requests, and training support.
• Organize, file, distribute, and archive source documents systematically for each clinical trial, ensuring proper documentation and accessibility.
• Support quarterly initiatives, including process improvements, training development, and workflow optimizations for source documentation.
• Participate in cross-functional meetings to provide input on study start-up timelines, protocol changes, and documentation impact analysis.
• Conduct internal audits and quality checks to ensure adherence to documentation standards and regulatory compliance.
• Develop and update standardized templates and checklists to improve the efficiency of source document creation.

The Expertise Required

• The Source Document Specialist must demonstrate a strong understanding of clinical trial protocols, GCP, and applicable regulatory requirements, including 21 CFR Part 11, to ensure compliant source documentation. Prior experience in clinical trials—particularly in a Clinical Research Coordinator (CRC) or similar role—is preferred and provides valuable insight into study workflows and data collection needs.
• The role requires proficiency in Microsoft Excel, Word, Outlook, Teams, and SharePoint, along with the ability and willingness to work within eSource platforms such as CRIO. Strong attention to detail is essential to identify discrepancies, manage version control, and ensure accuracy and traceability of source documentation.
• Successful candidates will demonstrate excellent organizational skills, the ability to prioritize tasks in a fast‑paced environment, and effective communication skills for collaborating with site staff, study teams, and regulatory stakeholders. A solution‑oriented mindset and the ability to assess and improve documentation workflows are critical to success in this role. The position requires comfort working both independently and as part of a global team, managing multiple systems, and adapting to evolving research and technology needs.
• Fluency in Portuguese (reading and writing) is required to create, review, and maintain Portuguese‑language source documentation for Brazil‑based studies. Fluency in English (reading, writing, and speaking) is required to communicate effectively with the global Source team and to review English‑language protocols, manuals, and regulatory documentation.

 Certifications/Licenses, Education, and Experience:    

• Education & Experience:
  • Bachelor’s degree in a health-related field (e.g., Life Sciences, Nursing, Public Health, or a related discipline) preferred. Equivalent work experience in clinical research may be considered.
  • Minimum of 2 years of experience in clinical research, with preferred experience as a Clinical Research Coordinator (CRC) or in a role involving source documentation, study execution, or regulatory compliance.
  • Strong knowledge of clinical trial operations, including protocol interpretation, source creation, and site workflow processes.
  • Experience working with Good Clinical Practice (GCP) guidelines, 21 CFR Part 11 compliance, and clinical trial documentation standards.
  • Microsoft Excel, Word, SharePoint, and other digital documentation tools.
• Certifications (Preferred but Not Required):
  • Certified Clinical Research Coordinator (CCRC) – from ACRP (Association of Clinical Research Professionals).
  • Certified Clinical Research Professional (CCRP) – from SOCRA (Society of Clinical Research Associates).
  • Good Clinical Practice (GCP) Certification – required or obtained upon hire.

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