Director of Clinical Research - Clinical Research * Days - 40hrs/wk
Requisition #: req253
FTE status: 1
In collaboration with the Chief Medical officer Develops, implements, and manages research policy, program development and research operations for the institution’s Clinical Research Department and Human Research Protection Program. Oversees all patient care delivery activities associated with research studies. Assures all clinical research responsibilities are in compliance with institutional policies and procedures, Food and Drug Administration (FDA) regulations, Department of Health and Human Services (DHHS) regulations, Office of Human Research Protections (OHRP) regulations, Healthcare Facilities Accreditation Program (HFAP), International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines, and other regulations as applicable.
- 1. Bachelor’s degree in health care, science or closely related field required
- ?Advanced degree preferred.
- Ten years combined work experience in clinical research and healthcare.
- Five years work experience in clinical research administration.
- Institutional Review Board experience preferred.
- Research Certification preferred and required to be obtained within 6 months of hire.
- Outstanding written, verbal communication, interpersonal, time management, and organizational skills.
- Self directed.
- Analytical and strong problem solving skills.
- Ability to work effectively and efficiently under tight deadlines, high volumes and multiple interruptions
- Ability to work well independently as well as a member of multiple, integrated teams.
Essential Functions and Responsibilities:
- Directs and oversees the development, implementation and education of all institutional clinical research and Human Research Protection Plan activities. Maintains, evaluates and assesses the need for new programs and technology. Facilitates the institution’s strategic plan for research.
- Develops, implements, monitors, updates and evaluates organizational clinical research and Human Research Protection policies and procedures in compliance with applicable regulations and policies.
- Insure current and accurate Federal Wide Assurance with the Office of Human Research Protections (OHRP) is maintained. Insure institutional readiness for FDA and other research regulatory site inspections. Facilitate institutional component of such inspections.
- Works with physician investigators and administration to review research trials for scientific, ethical and financial feasibility and applicability to setting. Makes recommendations for commitment to research projects.
- Facilitates development and review of legal contracts, grants and budgets for all clinical research activities. Works with internal experts and external consultants to develop and maintain a compliant research financial and billing compliance program. Assumes primary accountability and independent decision making for interviewing, hiring, recruitment, performance monitoring, mentoring, initiating counseling and corrective action and terminating of clinical research personnel. Authorizes time and attendance reports. Develops job descriptions.
- Responsible for department budget development and management.
- Serves as an institutional clinical research resource and liaison. Communicates and collaborates with staff, research participants and family members, management, vendors, physicians, executives, governmental agencies, and collaborators. Acts as a member, consultant or chair on organizational, community or national research committees and boards. Serves as a 24-hour organizational resource for patient and/or family member regarding research activities
- Assists in the development and review of investigator-initiated research proposals. Act as a mentor and resource for Graduate Medical Education (student and resident) initiated research.
- Ensures that processes and services are continuously monitored for quality, cost effectiveness, and efficiency. Engages in process and quality improvement activities. Makes and implements recommendations to improve operational efficiency and to implement new services for areas of responsibility.
- Performs other duties as assigned. These may include but are not limited to: Maintaining a current knowledge base of department processes, protocols and procedures, pursuing self-directed learning and continuing education opportunities, and participating on committees, task forces, and work groups as determined by management.