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Clinical Research Site Manager
2 months ago
Responsibilities
This position will cover facilities supporting oncology studies located in San Luis Obispo, CA and surrounding areas (Santa Maria and Oxnard).
Will consider relocation.
Job Summary / Purpose
The Clinical Research Site Supervisor reports to the Division Manager of Clinical Research Operations (DMCR). This position supervises senior to entry level RN and non-RN research coordination staff locally assigned to support Principal Investigators (PI), co- and sub-investigators, clinical and ancillary departments, IRBs, and industry or government sponsors of research to plan, coordinate, implement and complete clinical trials. The role will also function as a member of the research coordination team in all aspects of research coordination support including assisting where needed in the care of research participants and assessments of research participants that are appropriate within the scope of their role as an RN or non-RN.
This position will lead the research site team in management of all aspects of multiple clinical trials or other research projects as assigned, including but not limited to: research participant recruitment, screening and enrollment; completion of protocol required visits and procedures; collection and reporting of data; coordination of and participation in sponsor monitoring visits or federal audits; query resolution; adverse event reporting, source documentation and research record development and maintenance; study drug accountability; specimen collection, processing and shipment.This position works with the DMCR to ensure compliance of the research program and its studies with all applicable federal and state regulations.
In addition this local Site Supervisor role will be accountable to provide staff training, project leadership, and quality control oversight of the clinical research coordinator and/or clinical research nurse positions. This position is responsible for maintaining quality standards for responsive service and professional documentation in compliance.
Qualifications
- Bachelor’s degree, in a science or health related field, required.
- Demonstrated leadership competencies in the management of others required; Minimum (1) one year full time experience supervising research personnel preferred.
- Minimum (1) 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.
- Current RN license in state of employment required.
- 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.
- Thorough knowledge and understanding of research regulatory requirements involving human subjects research, including FDA, OHRP and GCP requirements required.
- Demonstrates the initiative to effectively lead in a team setting including acting independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.
- Knowledge base to provide clinical education to patients, families, and other staff, including patients who may have a terminal disease as it relates to the research.
