Position:Director, Biorepository Program, Clinical Trials Employment Type: Full Time Location: Dallas, TX Salary: $150,000-$200,000+ 25% annual bonus + Full Benefits + Relocation Hiring Organization: Healthcare System
US News and World Report “Best Hospital” Seeking Seasoned Biorepository Hospital Director
As one of the largest not-for-profit medical systems in the US, this Hospital and Research Center seeks a strong, experienced Clinical Director to lead the Biorepository Program and Clinical Trials. This position will coordinate operations for 100+ clinical trials, ensuring compliance from the staff, including skilled coordinators, research assistants, and technicians.
Recognized as one of the top 10% high-performing health systems nationally, the Clinical Research Institute works on clinical trials in over 50 medical specialties. The Biorepository Clinical Research Director will report to the Research Center’s Vice President and is responsible for trial operations and management of the first 4 phases of research programs. The Biorepository Director will collaborate with Operations Managers to grow the skills and knowledge of the investigators and research staff.
Overseeing clinical research and trial operations, the Director will develop trial budgets for the biorepository unit and ensure compliance. This role will partner with investigators and research coordinators to monitor expenditures and maintain billing compliance efforts. The Biorepository Director will retain the knowledge of all regulations and follow the appropriate protocols of IND studies and FDA submissions.
The ideal Clinical Director has experience building a Biorepository Facility from the ground up, including accreditations and policy formation. Biorepository Director must be hands-on, communicative, and lead by example.
Responsibilities of theDirector, Biorepository Program, Clinical Trials:
Provide coordination of projects associated with the biorepositories from Clinical Research Trials
Report to VP, Research and work collaboratively with Chief Regulatory Officer, and President of Research Center
Develop policies, procedures, and plans for clinical trial growth
Ensure preparation, the performance of quality control, and shipment of human specimens/samples are accurately completed
Manage Phases I through IV of trials related to pharmaceutical products and devices
Coordinate clinical protocols for research trials, negotiate project budgets, preparation of case report forms, summaries, and reports for FDA submissions
Oversee IRB application process and budget negotiation
Develop an annual operating budget for the department and monitor expenditures while overseeing Billing Compliance efforts
Partner with sponsors to ensure compliance with protocols and lead IND studies
Create and maintain databases of investigators to increase clinical trial activity by identifying investigators
Act as resource and contact for sponsors and investigators
Manage research coordinators, research assistants, and technicians and assign studies to appropriate staff
Provide coordinator and investigator education on regulatory obligations of clinical practices
Work with other Biorepository Managers to establish annual education programs
Review staff performance and conduct disciplinary actions and work assignments
Maintain knowledge of federal, state, and local regulations
Requirements for the Director, Biorepository Program, Clinical Trials:
Master’s of Science in Biobanks and Complex Data Management, Biology, Clinical/Healthcare Research, or related field
Doctorate (Ph.D.) in Clinical Research, Health Science, Pharmacy, or related field preferred
5+ years of Biorepository, Biobank, or related experience
QBRS, CCRC, CPH, or associated certifications
2+ years of clinical laboratory leadership/management experience
HCLD, PRC, CCRP, or related certifications
Knowledge of universal precautions and quality controls
Prior experience with LIMS
Why You’ll Love It:
Competitive Salary with a 25% annual bonus and complete benefits package
Benefits include: Immediate eligibility for health and welfare benefits, 401(k) savings plan with dollar-for-dollar match up to 5%, Tuition Reimbursement, and PTO accrual beginning Day 1
Excellent area schools and higher education options
U.S. News & World Report Recognized Most Awarded Not-for-Profit Health System