CLINICAL RESEARCH COORDINATOR SUPERVISOR
Duties: The responsibilities of the Clinical Research Coordinator Supervisor include but are not limited to:
* Assist with strategic planning for development of study teams and staffing plans. Assist drafting job descriptions, PIQs, recruitment ads, candidate assessment tools and for completing all new hire documentation and training plans.
* Supervise all junior CRC team members and manage workload and performance.
* Lead annual evaluation efforts for all junior CRC team members by coordinating team feedback, self-appraisals, and preparing and submitting all required documentation.
* Develop and implement regulatory plans for multi-site studies (40-50 sites), appropriately identifying and securing institutional guidance and resources and effectively assigning team members for preparation of regulatory documentation
* Supervise the effort of junior clinical research staff in the drafting, tracking, and maintenance of all regulatory submissions including all documents required for initial study submissions, continuing reviews, modifications, deviations, exceptions, and
* Serve as liaison between external study sites and institutional contracting leadership for the purposes of site budget negotiations, financial disclosures, and subaward agreements.
* Assess and facilitate review of all AE and SAEs. Prepare and submit all required documentation and reports per UPenn, sponsor, FDA and other applicable regulating entity requirements.
* Serve as lead for post-award communications with study sponsor. Complete all sponsor documentation and reporting requirements.
* Adhere and guide staff on all University of Pennsylvania, GCP, and FDA guidelines.
Qualifications: The qualifications required for the Clinical Research Coordinator Supervisor position include:
* Minimum of Bachelor's degree and 5-7 years of experience in clinical research, or an equivalent combination of education and experience, are required. Master's degree and 3-5 years of experience post-Master's preferred
* At least 3-5 years of supervisory experience in clinical research
* Extensive knowledge of human research protection regulations
* Experience with complex multi-site regulatory submissions and reliance agreements
* Experience managing multi-site clinical trials
* Experience leading communications with study sponsors and institutional leadership
* Excellent communication and interpersonal skills
* Excellent organization skills and demonstrated attention-to-detail
* Demonstrated independent initiative and ability to work independently with minimal supervision
* Ability to multi-task and be flexible in both task and schedule
* Proficient with Microsoft Office Suite and electronic study tracking systems
Reference Number: 40-27496
Salary Grade: 028
Employment Type: Exempt
Job Family: I-Technical/Professional Research