We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Start Up Lead (SUL) in Mexico!

The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:

• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:

• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

Preferred:

• Advanced degree in life sciences or related field

Competencies:

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information.
• Excellent organizational skills.
• Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located.
• Ability to work independently in a fast-paced environment with a sense of urgency to match the pace.
• Must demonstrate excellent computer skills.
• Excellent time management and prioritization skills to ensure deadlines are met.
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Occasional travel may be required.

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Start Up Lead (SUL) in Mexico!

The Start Up (SU) Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning, including the management and coordination activities such as Core/Site document collection and approval, ICF customization and approval, IRB/EC and CA/ MoH submissions and delivery of quality IMP release packages. Will act as Subject Matter Expert for questions by other in-country members (SUSs, CRAs, CSSs or others) supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities.

Essential functions of the job include but are not limited to:

• Manage the site start up process through development of an activation readiness strategy to enable oversight of site start up delivery.
• Coordinate, develop and present critical path planning including IRB/EC & CA/ MoH Strategy, ICF Customization, Risk Mitigations, IMP Release Requirements and Contract Execution.
• Collaborate and communicate with stakeholders to secure input for milestone planning, and alignment of operational goals to ensure timely delivery of site start up activities to allow on time activation.
• Participate in client meetings to establish client expectations for delivery, communication, risk mitigation strategy, status reporting, and metrics related to site start up.
• Partner closely with Functional Leaders and Site Start up Specialists to proactively identify any risks to delivery and develop and execute mitigations to remove risks to timelines.
• Provide oversight to ensure accuracy and completeness of agreed tracking and systems are maintained in real time to allow analysis of progress metrics against targets/timelines at study, country, and site levels.
• Responsible to co-ordinate translations for documents required for submissions.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory and Site Contracts management group on project specific status and deliverables.
• Act as SME for collection and maintenance of site level critical path to IMP Release data points such as local IRB/Ethics Committee (EC) timelines, other required reviews to secure activation, site contracts and budget negotiation requirements that may be in place as well as other start up requirements for assigned country.
• If needed, directly support country or site level activities start up activities.
• Support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors.
• Support development and facilitation of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries.
• Mentor staff on local study start-up regulations, submissions, internal procedures and SSDL.
• Interact with clients in proposal activities, including slide development and client presentation as required.
• Performs other duties as assigned by management.

Qualifications:

Minimum Required:

• Bachelors degree in life sciences or related field, or Registered Nurse (RN) or equivalent combination of education, training, and experience.
• 5 years or more in start up, ideally with SU Lead or PM experience in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies.
• 2 years or more experience in project milestone management, managing resources, budgets and coordinating team activities.

Other Required:

• Demonstrated leadership experience in driving cross-functional activities
• Excellent communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• Fluency in English and for non-English speaking countries the local language of country where position based.
• Experience using milestone tracking tools/systems

Preferred:

• Advanced degree in life sciences or related field

Competencies:

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements.
• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information.
• Excellent organizational skills.
• Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located.
• Ability to work independently in a fast-paced environment with a sense of urgency to match the pace.
• Must demonstrate excellent computer skills.
• Excellent time management and prioritization skills to ensure deadlines are met.
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Occasional travel may be required.

#LI-AG2 #LI-REMOTE

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Regulatory and Start Up Specialist (Senior RSS) in Mexico!

As the Senior RSS on our team, you are a seasoned, experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the Senior RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and providing support to the Site Contract Management group in budget and contract negotiation.

The Senior RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities, trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities and ensure compliance with local and international clinical trials regulations and guidelines.

Essential functions of the job include but are not limited to:

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities (CA), Ethics Committee (EC) and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP
• Interaction with CA/EC for study purposes and handling responses to the CA/EC
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria
• Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration
• Prepare, review and manage collection of essential documents required for site activation/IMP release
• Customize country/site specific Patient Information Sheet and Informed Consent Forms.
• Responsible for/facilitates the translation and co-ordination of translations for documents required for submission
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within Precision for Medicine to ensure the conduct of Clinical Trials according to international and local/national applicable regulations
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study
• May support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors
• May support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries
• May mentor staff on local study start-up regulations, submissions, and internal procedures
• May interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as required
• Performs other duties as assigned by management

Qualifications

Minimum Required:

• Bachelors’ degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience
• 3.5 years or more as a Regulatory or SU specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Other Required:

• Excellent communication and organizational skills are essential
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required
• Fluency in English and for non-English speaking countries the local language of country where position based
• Ability to prioritize workload to meet deadlines

Preferred:

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/EC/IRB submissions) experience for the particular country
• Experience using milestone tracking tools/systems
• Can assist junior SU specialists in problem resolution
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science

Competencies:

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information
• Excellent organizational skills
• Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located
• Ability to work independently in a fast-paced environment with a sense of urgency to match the pace
• Must demonstrate excellent computer skills
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• Flexible attitude with respect to work assignments and new learning
• Occasional travel may be required

#LI-AG2 #LI-REMOTE

We’re expanding our capabilities across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re hiring a Senior Regulatory and Start Up Specialist (Senior RSS) in Mexico!

As the Senior RSS on our team, you are a seasoned, experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the Senior RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and providing support to the Site Contract Management group in budget and contract negotiation.

The Senior RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities, trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities and ensure compliance with local and international clinical trials regulations and guidelines.

Essential functions of the job include but are not limited to:

• Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks
• Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities (CA), Ethics Committee (EC) and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP
• Interaction with CA/EC for study purposes and handling responses to the CA/EC
• Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team as relevant
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria
• Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration
• Prepare, review and manage collection of essential documents required for site activation/IMP release
• Customize country/site specific Patient Information Sheet and Informed Consent Forms.
• Responsible for/facilitates the translation and co-ordination of translations for documents required for submission
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables
• Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country
• When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department
• Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within Precision for Medicine to ensure the conduct of Clinical Trials according to international and local/national applicable regulations
• Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing Pre-Study Site Visits
• May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study
• May support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors
• May support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries
• May mentor staff on local study start-up regulations, submissions, and internal procedures
• May interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as required
• Performs other duties as assigned by management

Qualifications

Minimum Required:

• Bachelors’ degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience
• 3.5 years or more as a Regulatory or SU specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies
• Ability to communicate both verbally and in writing at the English proficiently (Professional level)

Other Required:

• Excellent communication and organizational skills are essential
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required
• Fluency in English and for non-English speaking countries the local language of country where position based
• Ability to prioritize workload to meet deadlines

Preferred:

• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/EC/IRB submissions) experience for the particular country
• Experience using milestone tracking tools/systems
• Can assist junior SU specialists in problem resolution
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science

Competencies:

• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information
• Excellent organizational skills
• Ability to effectively interact with project team(s) and effectively communicate in English and the local language of the country where located
• Ability to work independently in a fast-paced environment with a sense of urgency to match the pace
• Must demonstrate excellent computer skills
• Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
• Flexible attitude with respect to work assignments and new learning
• Occasional travel may be required

#LI-AG2 #LI-REMOTE

Science 37’s Nursing Solutions Group brings together expert nurses who share a passion for organizing, planning and implementing mobile clinical nurse services to participants in clinical trials. Science 37’s extraordinary work environment allows continuous collaboration between clinicians, clinical researchers, patient recruitment specialists, data managers and technology developers. The Nursing Solutions Group is involved throughout the trial life cycle, from protocol development and feasibility analysis to clinical trial implementation and closeout.

The Per Diem Mobile Research Nurse is a Registered Nurse who will work per diem and has experience across multiple therapeutic areas with the ability to work independently and integrate well with the Nursing Solutions Group. With interest/expertise in Science 37’s decentralized model of care delivery, the Mobile Research Nurse will perform delivery of care to participants as well as collaborate with brick and mortar sites, if indicated, for shared clinical trial implementation. The Mobile Research Nurse ensures the professional delivery of patient care in compliance with all federal and state regulations, Good Clinical Practice, and Standard Operating Procedures. 

*This is a travel role that requires on-site visits to participants homes.

Duties for this position include but are not limited to:

1. Participate and provide research nurse services to qualified study participants at home
2. Apply clinical research and nursing practices to develop solutions to complex problems
3. Collaborate with Lead and Per Diem Mobile Research Nurses on solutioning, education, and resource support
4. Participate in activities that will further the operational development of Science 37 nursing service delivery
5. Develop relationships with study team members and serve as the subject matter expert (SME) on all nursing processes
6. Other duties as assigned as the needs of Science 37 evolve and change

This position has the following qualifications:

1. BSN degree preferred
2. Full Covid Vaccination strongly preferred. Science 37 follows CDC guidelines for vaccination recommendations and such guidelines are subject to change.
3. Active RN licensure in home state as well as eligibility for Compact Licensure required
4. Minimum 2+ years clinical/research experience preferred
5. Basic Life Support (BLS) Certification
6. Maintain a positive reflection of the company by representation in participant’s homes or in clinic settings
7. Travel and availability qualifications are as follows:
   1. 1-2 days minimum a week dedicated to support Science 37's study visits
      1. Weekday/night availability required
   2. Must be willing to travel to a participants homes 
   3. Active Driver’s License

Science 37 is looking for people with the following skills and competencies:

1. BSN degree preferred
2. Active RN licensure in home state as well as eligibility for Compact Licensure required
3. Minimum 2+ years clinical/research experience preferred
4. Basic Life Support (BLS) Certification
5. Active Driver’s License
6. Weekday/night availability required
7. Maintain a positive reflection of the company by representation in participant’s homes or in clinic settings
8. Up to 100% travel, as needed, for study participant visits, project team meetings, and other professional meetings/conferences as needed
9. Ability to obtain nursing license in multiple states based on study needs
10. Physical ability to perform nursing tasks and lift equipment up to 15 kg in weight
11. Access to a reliable vehicle to perform study participant visits and transport equipment
12. Ability to drive to local and/or remote locations to perform study participant visits
13. Ability to use technology effectively and appropriately for study participant assessments and documentation including but not limited to study participant care equipment, laptop computers, communication devices and tablets
14. Ability to communicate in English (both verbal and written)

There is minimal supervision for this position, with individuals reporting to the Manager, Nursing Solutions Group.

Compensation varies based on location and work being performed. The starting pay range for a candidate selected for this position is generally within the range of $50-55 per hour. Employees may be eligible for additional discretionary bonuses and commissions. The successful candidate’s actual pay will also be based on qualifications and experience, so the actual starting pay may be above or below this range.

Science 37 is an equal opportunity employer.  

We are committed to creating a diverse environment and is an equal opportunity employer. All qualified applicants receive consideration for employment without regard to age, race, ethnicity (including but not limited to hair texture and protected hairstyles), ancestry, color, sex, national origin, sexual orientation, gender, gender identity, gender expression, transgender status, religious creed, physical or mental disability (including actual or perceived disability), medical condition (including HIV/AIDS), pregnancy, perceived pregnancy and pregnancy related conditions, genetic information, marital status, political affiliation or activities, status as a victim of domestic violence, assault, or stalking, veteran status or participation in the uniformed military services of the United States, including the National Guard, or any other basis prohibited by applicable law.

Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed. 

Submit your resume to apply!