Research Regulatory Program Manager - Research - Full Time - Days
The Research Regulatory Program Manager is a member of the research team and ensures compliance with all regulatory institutional and departmental requirements. The Program Manager will be responsible for programmatic maintenance support of clinical trials and specific responsibilities will include all. support personnel and participates in all activities for the coordination & preparation of regulatory submissions and design and works with the Clinical Trials staff to implement improvements in communication, monitoring, and enforcement of compliance standards.
1.Maintenance of regulatory master files for industry & investigator initiated clinical trials. Submission of study amendments in a timely fashion including changes to the protocol, consent forms and other study documents. Work closely with the Director of Institutional Research to provide the project teams with regulatory input in order to obtain timely regulatory approvals for the project and protocols. 2.Accurate preparation of annual renewals & study closure for IRB & sponsors. 3.Meet & correspond with sponsor and/ or CROs during monitoring visits and ensure study regulatory files are up to date & audit ready. Coordinates communication with investigators and members of the research team to aid in study development and oversight throughout the life- cycle of clinical trial. 4.Acts as liaison, along with the Director of Institutional Research in working with the Yuma Regional Medical Center Compliance, to help ensure that the hospitals policies, procedures and operating guidelines conform to laws, regulations and industry practices. Obtain continuing approvals from various committees and organizations (Institutional Review Board). 5.Ensure that alt state and federal regulatory requirements are addressed for the clinical research projects. Maintaining knowledge of Good Clinical Practice (GCP), clinical research activities and guidelines related to consent, ethical conduct and protection of human subjects. 6.Develops and/or revises regulatory standard operating policies and procedures. Aid in the development of protocol specific standard operation procedures. Along with the training offered by the Institutional Research Department, provide employee training on research regulatory and compliance related topics, policies, or procedures. Conduct training sessions for regulatory staff, CRCs, CRAs and Project Managers. Develop & maintain regulatory knowledge of current regulations. 7.Conduct periodic Compliance internal reviews or audits to ensure that compliance procedures are followed. Work closely with the Director of Institutional Research, Principal Investigators and coordinators to provide assistance to internal or external auditors in compliance reviews.
REQUIRED: 5+ years of Human Subject Clinical Research environment, with at least 3 years of experience as a Regulatory Coordinator and a strong background and experience working with IRB and regulatory agencies. A broad understanding of research compliance issues preferred.
Work Schedule: 8-hours, Days, Monday through Friday
Physical Requirements and working conditions for this position will be provided to you upon interview.