Cofactor Genomics
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:
Bachelor level degree
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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:
Bachelor level degree
#J-18808-Ljbffr