Reporting to Fractyl's Director, Clinical Operations, the Senior Clinical Trial Associate participates in the planning and coordination activities of clinical trials. This role provides project support for the initiation, execution and close-out of domestic and international clinical studies to support both product approvals and market adoption of company products. The Sr. CTA is also responsible for supporting the project teams to achieve quality results in a cost-effective and timely manner. S/he assists the Clinical Operations team with establishing key practices, procedures and processes in preparation for future expansion and growth.
• Set-up, update and maintain clinical trial-related trackers such as regulatory documents, trial master file, start-up progress, screening/enrollment, study invoices/payments, project budgets and others as necessary;
• Prepare, maintain, and archive trial master files;
• Perform trials master file reviews to ensure completeness and audit-readiness;
• Maintain Regulatory Document Trackers;
• Assist with system access and tracking users, in coordination with the CRO/vendors;
• Review regulatory packets for investigational device shipments;
• Maintain study team roster;
• Coordinate, provide set up, and attend project meetings including: internal team, CRO / vendor meetings, support presentations, etc.;
• Assist with preparing agendas and taking meeting minutes for internal project meetings;
• Support the Clinical Operations team in the successful execution of assigned clinical trials from protocol concept to clinical trial report, complying with international Good Clinical Practice (GCP) guidelines/regulations and Standard Operating Procedures (SOPs);
• Coordinate the preparation, collection and execution of confidential disclosure agreements (CDA);
• Distribute, collect and review Financial Disclosures;
• Support audit/inspection readiness;
• Assist with circulating annual reports, IRB/EC submissions, queries, and responses for team review;
• Assist with compiling regulatory submissions;
• Regularly review documents to ensure adherence to Clinical Operations and/or project specific quality requirements (e.g. SOPs, work practices, training guides) as applicable;
• Provide detail reviews for protocol, informed consent form (ICF), case report form (CRF) design, etc.;
• Assist with identifying and implementing best practices and continuous improvement plans within the company;
• Mentor junior Clinical Trial Associates as assigned;
• Bring a “can-do” attitude to Fractyl and deliver on other related responsibilities as assigned.
Education or Certification Requirements
• Bachelor degree in scientific or business field of study within Medical Device or related industries
Professional Work Experience
· A minimum of 2- years of experience in a similar role in biotech (medical device experience a plus).
· Exposure to clinical trial operations, ICH, GCP Guidelines and other applicable regulatory requirements.
· Experience overseeing Trial Master File.
· Experience managing administrative project tasks.
· Experience working with CROs and other outsourced vendors.
· Experience with team environment.
· Proficient in Microsoft Office (e.g., Word, Excel, and Outlook) and web-based systems.
· Prior vocational experience in related fields a plus (i.e. Co-Ops, Internships, Fellowships, etc.).
Other Essentials and Key Success Factors:
· Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spirit
· Ability to participate in 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
· Self-motivated individual who is able to work autonomously, as well as working as a member of teams
· Highly organized and detail oriented with a passion to deliver quality results
· Strong verbal and written communication skills, with an ability to build relationships internally and externally
· Highest levels of professionalism, confidence, personal values and ethical standards
• None anticipated at this time.
The description and requirements outlined above are general; additional requirements may apply.