Vital Strategies is seeking a qualified candidate for the position of Clinical Research Fellow who will be responsible for assisting the Research Division in its final activities for the STREAM clinical trial, including closeout of trial sites, dissemination of trial results, communications activities, and supporting secondary research with trial samples and data.
Vital Strategies is committed to building a diverse, equitable and inclusive (DEI) organization. We welcome applications from people of all backgrounds and do not discriminate on the basis of race, color, religion or creed, gender, national origin, ancestry, actual or perceived age, physical or mental disability, veteran or military status, marital status, sexual orientation, predisposing genetic characteristics, alienage or citizenship status, gender (including gender identity or expression), partnership status, arrest or conviction record, status as a victim of domestic violence, status as a victim of sex offense or stalking, or any other basis protected by local, state, or federal laws.
This is a remote working position, fixed-term one-year contract and can be based in the following countries: U.S. or U.K. All U.S. employees will be required to be fully vaccinated unless the employee is approved for a reasonable accommodation due to a disability or a religious reason.
We offer highly competitive compensation and comprehensive benefits. The salary range for this position in the U.S. is $105,600 – $123,200 USD. For candidates in the U.K. the salary range will be bench marked to the U.K. market. Applicants must have valid work authorization to work in the U.S. or the U.K.
Specific Duties and Responsibilities:
Under the direction of the VP Research Division:
- oversee trial implementation at assigned trial sites, including development and implementation of work plans and regulatory strategies, and troubleshooting all issues with site PIs and regulators
- conduct site monitoring and closeout visits to assigned trial sites
- develop and implement close out plans for all trial sites in collaboration with partners, including drafting and/or coordinating any final reports to country-level regulators
- oversee the insurance strategy and program for clinical trials
- sit on trial oversight bodies, including trial management group
- develop and implement capacity building programs for trial sites and partners
- oversee coordination of final Clinical Study Report (CSR) in collaboration with partners and funders
- ensure trial registries are up to date
- oversee biobanking arrangements for clinical trial samples
- coordinate/undertake secondary analyses of trial data and samples for publication in peer-reviewed journals
- support trial results dissemination, including community-level dissemination and evaluation
- other research-related activities as requested
Qualifications:
Education & degree
- Masters in Public Health or similar
Skills & Abilities
- Strong generalist – thrives on analyzing/solving new challenges
- Independent thinker
- Team player – happy to pitch in as needed to reach a common goal
- Facility with budgeting and work planning
- Excellent written and oral communication skills in English
- Excellent Microsoft Word/Excel/Powerpoint skills
- Understanding of ethics and regulatory frameworks applicable to clinical trials
- Understanding of US FDA / ICH requirements for clinical study reports a plus
Experience:
Required –
- Substantial experience managing research at an academic institution, sponsor, CRO or other
- Experience with ethics committee and regulatory applications/submissions for clinical research
Preferred –
- Experience managing US FDA-regulated research
- Experience producing US FDA/ICH-compliant clinical study reports
- Understanding of the US common rule and its application to international research