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Clinical Research Site Supervisor
2 months ago
Position: Clinical Research Site Supervisor (RN)
Location: On-site - San Luis Obisbo, CA
Duration: 6-month contract to hire
Job Summary:
The Clinical Research Site Supervisor, reporting to the Division Manager of Clinical Research Operations (DMCR), supervises senior to mid-level RN and non-RN research coordination staff. This role supports Principal Investigators, co- and sub-investigators, clinical and ancillary departments, IRBs, and research sponsors in planning, coordinating, implementing, and completing clinical trials and other research projects. Responsibilities include assisting with research participant care, leading the research site team in managing clinical trials, participant recruitment, protocol visits, data reporting, sponsor monitoring, query resolution, adverse event reporting, documentation, drug accountability, and specimen handling. The Supervisor ensures compliance with federal and state regulations and organizational policies, provides staff training, project leadership, quality control oversight, and maintains quality standards. This exempt position may require occasional overnight travel and work outside normal hours.
Requirements:
- Bachelor’s degree, in a science or health related field, required.
- Demonstrated leadership competencies in the management of others required; Minimum one year full time experience supervising research personnel preferred.
- Minimum one year full time experience in role performing duties as a Senior Research Coordinator
- Minimum 7 years of progressively responsible experience coordinating clinical trials required; worked as primary research coordinator for at least 20 drug or device trials.
- Minimum of 7 years of experience interacting with patients in a healthcare setting required.
- Experience in implementation of research protocols and clinical trials processes required.
- Experience in preparing and maintaining regulatory documents and other IRB-related study documentation required.
- Demonstrated competencies to train staff and/or investigators on clinical trial processes and improvement techniques required.
- Experience using electronic data capture software required; Clinical Trial Management Systems (CTMS) preferred.
- Lab processing experience required.
Licensure and Certifications:
- Current RN license in state of employment required (for RN candidates only).
- BLS certification required.
- IATA and/or Safe-T-Pak certification for shipment lab specimens and/or dry ice
- Current certification (CCRP or CCRC) by the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) required.
- Current certificate of Human Subjects Protection and Good Clinical Practice training required.
Required Minimum Knowledge, Skills, Abilities, and Training:
- Thorough understanding of research regulatory requirements for human subjects, including FDA, OHRP, and GCP.
- Initiative to lead effectively in a team setting, act independently, and make decisions within study protocols and regulatory constraints.
- Ability to adapt and lead in changing environments to achieve team outcomes.
- Knowledge of ethical principles, culture, and values of medical research.
- Critical thinking, decisive judgment, and ability to work with minimal supervision.
- Ability to work independently and collaboratively with physicians, research teams, IRBs, hospital personnel, and sponsors.
- Competence in performing all research coordination duties for multiple clinical trials simultaneously.
- Ability to provide clinical education to patients, families, and staff, including those with terminal illnesses related to research.
- Excellent verbal and written communication skills.
- Highly motivated and flexible, with the ability to adjust to changing priorities and new projects.
- Proven success in identifying and securing new trials and growing research site volume.
- Strong attention to detail, multi-tasking, organization, and prioritization of projects.
- Ability to formulate logical conclusions and recommend effective solutions.
- Effective communication with a wide range of healthcare professionals and agencies.
- Proficiency in writing reports, business correspondence, and procedure manuals.
- Understanding of basic clinical trial budgeting principles.
- Decision-making ability in ambiguous situations to achieve project milestones.
- Skills in word processing, spreadsheets, graphic representation, and familiarity with data/financial reporting systems.
- Proficiency with audio/visual media and Clinical Trial Management Software (CTMS) systems.
- Ability to enforce timelines and escalate issues as needed.
- Action-oriented and able to travel as required.
