Description:
This position will work under the general direction of PACCM principal investigators and with the Research Nurse Manager to assist in the oversight of our expanding group of active PIs and research staff. Excellent computer skills are required including MS Word and demonstrated proficiency in Excel. The candidate must also demonstrate strong written and verbal communication skills and the ability to independently prioritize and manage the oversight of research projects under 4-6 faculty in our division. They must be detail-oriented and have strong problem-solving and organizational skills. Most importantly, the CRM will possess superior written and verbal communication skills to effectively and compassionately interact with multiple health care professionals, sponsors, research staff, and patients.
Duties Include
- Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels, and identify adequate coverage for trial workload across teams of study coordinators.
- Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures.
- Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Develop consent forms for approval by Human Subjects Panel.
- Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required.
- Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions.
- Provide leadership and expertise in identifying and completing research grants. Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.
- Lead or chair committees or task forces to address and resolve significant issues.
- Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
- Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial, track physician compliance.
- Assist with analysis of data and preparation of manuscripts and scientific presentations.
Education & Experience (required)
- Bachelor’s degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred.