Candidate will supervise, initiate, monitor and manage Phase I, II and II clinical studies at the company level and at participating study sites.
A Bachelor's degree is required and 4 plus years of direct related work experience with clinical studies.
This position is Full-Time, Exempt and reports to the Associate Director, Clinical Research and requires frequent travel.
Position is not eligible for relocation benefits.
1. Continue to recruit, manage, and monitor clinical sites
2. Serve as liaison between the contracted research organizations,
field sites, investigators, study coordinators, pharmacists and
3. Participate in pre-study and site initiation planning.
4. Assist in writing and developing clinical protocols, SOM's, data and
tracking forms, clinical site and overall clinical trial budgets,
informed consent documents and operating procedures.
5. Assist in the creation, management, and maintenance of clinical
regulatory documents including the SMF's and TMF's.
6. Monitor clinical laboratory data to ensure accuracy, thoroughness,
and regulatory compliance of clinical documentation. Ensure
resolution of data queries.
7. Provide technical assistance to study sites regarding the conduct of
8. Oversee and perform clinical safety monitoring, site evaluation and
9. Assist in writing annual and final clinical study reports and
clinical sections of regulatory filings.
10.Other job duties as assigned.
Additional Preferred Skills
CITI certification, HIPAA, Practitioner's License or any other clinical trial certifications a plus.