Reports to: Clinical Trial Manager
PositionSummary
The SrClinical Research Associate provides trial support for the initiation, execution, and compliance of clinical studies to supportbothproductapprovalsandmarketadoptionofcompanyproducts.Workingcloselywithclinicaloperationsand other cross-functional team members, the Sr 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.
PrimaryResponsibilities
InvestigatorRelations
- 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
SiteSupportandQualityAssurance
- 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
EducationorCertificationRequirements
- Bachelor’s degree in a science-based discipline
- Degree in Nursing preferred
Professional Work Experience
- 5+ 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 50-75% travel.
The description and requirements outlined above are general; additional requirements may apply.
