Reports to: Clinical Trial Project Director
Position Summary
The Clinical Trial Associate will aid in study start up activities for Fractyl’s global clinical program, draft SSU documents, site regulatory document review and approval, and IRB/EC and regulatory submissions and approvals. Working closely with the clinical operations team members, the Clinical Trial Associate will liaise with internal and external partners to distribute continuous status updates. Main responsibilities include, but are not limited to, participating in the planning and coordination of clinical trial activities; providing project support for the initiation, execution and close out of clinical studies, working closely with internal teams and external vendors; and supporting project teams to achieve quality results in a cost‐effective and timely manner.
Primary Responsibilities
- General
- Support the Clinical Operations team in the successful execution of clinical trials from protocol concept to clinical trial report, complying with international ICH/Good Clinical Practice (GCP) guidelines/regulations and Standard Operating Procedures (SOPs)
- Assist project teams with trial progress by updating study trackers
- Submit clinical documents in quality management system for management and team approval
- Perform all activities in compliance with applicable regulations, Fractyl’s policies and guidelines, including, but not limited to, timely documentation of activities and maintaining all required applicable training.
- Bring a “can do” spirit to work and deliver on other responsibilities as assigned.
- Study Start Up
- Help coordinate site regulatory document review and approvals
- Help Sr Specialist manage IRB/EC and regulatory submission and approvals, including amendments and continuing reviews
- Maintain SSU documents in internal TMF and maintain inspection ready documentation
- Clinical Trial Administration
- Support the Clinical Operations team in the successful execution of clinical trials from protocol concept to clinical trial report, complying with international ICH/Good Clinical Practice (GCP) guidelines/regulations and Standard Operating Procedures (SOPs)
- Arrange, organize, and maintain clinical study documentation, including but not limited to, preparing for internal/external audits, final reconciliation, and archival
- Assist project teams with trial progress by updating study trackers
- Support the development of slides and presentations materials
- Perform Trial Master File (TMF) reviews to ensure completeness and audit‐readiness
- Request, manage, distribute and track study supplies (Regulatory Binders, Study Reference Manuals, Patient Diaries, consumables & ancillary supplies, etc.)
- Support overall vendor coordination (process document updates, systems coordination, supplies coordination, etc.)
Education or Certification Requirements
- Bachelor’s degree in scientific or business field of study
Professional Work Experience
- 1-3 years of experience at a Pharmaceutical, Biotech, Medical Device Company, CRO, or equivalent site experience
- Direct experience in preparing and delivering Start-Up activities
- Proficient in Microsoft Office (e.g., Word, Excel, and PowerPoint), Google docs and web‐based systems
- Applicable experience in biotech, pharmaceutical and/or medical device industries preferred
- Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.)
Qualifications and Skills
- Understanding of complexities of study start up
- Desire to learn and expand knowledge and skillset
- Self‐motivated individual who can work autonomously, as well as working as a member of teams
- Must be highly adaptable to competing deadlines and changes in priorities
- Must have a strong attention to detail
Other Essentials and Key Success Factors
- Successful track record of working in high-growth and dynamic organizations
- Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
- Ability to lead fast-paced projects with a keen sense of urgency to get the job done well
- Evidence of "hands-on" experience and expertise
- Proven and successful track record as a team-player and collaborator in small working environments
- Highly organized and detail oriented with a passion to deliver quality results
- Excellent verbal and written communication skills, with experience translating technical concepts into user-friendly documentation
- Highest levels of professionalism, confidence, personal values and ethical standards
Travel
This position requires 0% -5% travel.
The description and requirements outlined above are general; additionalrequirements may apply.
