Reports to: Clinical Trial Manager (unblinded)
Position Summary
The unblinded Clinical Research Associate provides trial support for the initiation, execution, and compliance of clinical studies to support both product approvals and market adoption of company products. Working closely with clinical operations and other cross-functional team members, the CRA liaises with vendor teams to ensure successful clinical trial execution, ensuring accuracy and 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.
Primary Responsibilities
Investigator Relations
- Develop and maintain individual investigator relationships, guiding them on protocol data requirements and reviewing their progress on a regular basis
- Ensure adherence to ICH-GCP and Regulations
- Facilitate scientific discussion on product and protocol requirements
Vendor Contracts/Management
- Monitor, evaluate and resolve all vendor issues
- Drive timelines and provide guidance on all protocol, technology, and data questions
- Train and assist site coordinators, investigators, field clinical staff, CRO (as applicable) in collecting data in a timely manner that meets the protocol requirements and timelines/milestones
- Liaise with study site staff to ensure timely and accurate CRF data
Site Support and Quality Assurance
- Conduct Site Evaluation, Site Initiation, Interim Monitoring and Close Out visits
- Serve as first point of contact for site staff
- Administer protocol and study related training to sites
- Monitor clinical sites, assessing any potential discrepancies and working with internal management and clinical site teams to identify and implement resolutions
- Manage device/medication accountability and inventory throughout clinical study
- Monitor study to ensure sites are in compliance with protocol, SOPs and regulations
- Complete accurate monitoring reports and follow up letters in a timely manner
- Review clinical study reports for regulatory submissions and follow up on assigned action items and queries
- Ensure rights, safety and well-being of trial subjects are protected and the data is accurate and verifiable
- Perform source data verification and ensure accuracy and completeness
- Ensure quality of the data by performing regular reviews of data according to data review/monitoring guidelines.
- The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s).
- Provide regular (weekly/biweekly) project communications with Clin Ops regarding key clinically meaningful data
- 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
Education or Certification Requirements
- Bachelor’s degree in a science-based discipline
- Degree in Nursing preferred
Professional Work Experience
- 3+ years of monitoring experience on clinical trials
- 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
- In depth knowledge and skill in applying applicable clinical research regulatory requirements (i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Must have knowledge of and direct experience with Microsoft Office: Word, Excel, PowerPoint, OneNote, Outlook, and Adobe Acrobat.
- Experience with controlled clinical terminology and clinical trial systems such as TMF/eTMF, CTMS, EDC, IVRS/IWRS, ePRO is highly preferred
- Excellent organizational and problem-solving skills
- Effective time management skills
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 up to 25-50% travel.
The description and requirements outlined above are general; additional requirements may apply.
