Key Responsibilities
- Oversee all aspects of Cofactor Genomics' PREDAPT clinical trial (NCT04510129)
- Ensure regulatory compliance and maintain highest standard for clinical trial management, including monitoring that sites are executing all required activities
- Monitor trial EDC, clinical trial data, and processes
- Create informational materials to provide clinical sites
- Answer logistical and technical questions regarding trial requirements and patient eligibility
- Communicate with clinical sites and vendors to ensure trial success
- Manage on-boarding of new trial sites and site closures
- Create and coordinate monthly communication with clinical trial sites
- Communicate clearly and promptly with all trial stakeholders (written and verbal)
- Coordinate and be directly involved with team on sample procurement initiatives and new site recruitment
- Coordinate with lab on clinical sample procurement, receipt, logistics, packaging, shipping, tracking, and follow-up
- Work to expand trial to new indications
- Support customer success and support teams
- Support early clinical testing efforts, including site communication and education
- Assist in onboarding trial sites for clinical testing
Requirements & Competencies
The successful candidate will have demonstrated the following competencies, skills, and experience:
- Self motivated and able to function independently
- Ability to launch new clinical trial initiatives
- Experience working on clinical trials, preferably overseeing trials for the sponsor
- Ability to motivate sites to recruit patients for trial
- Availability for occasional travel to study sites
- Ability to learn and use data and trial management software proficiently
Credentials
Successful candidates will have the following qualifications: