Research Regulatory Consultant

Consultant, Regulatory

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The Consultant, Regulatory will provide regulatory management oversight for pre-award and post-award activities for clinical trials and research projects to provide system-wide support of Ohio Health research activities in accordance with Good Clinical Practices (GCP). Activities include a variety of complex and varied regulatory and administrative support functions such as analyzing protocols, developing informed consent documents, developing and maintaining study regulatory documents, establishing and maintaining comprehensive regulatory recordkeeping systems, preparing study amendments, and maintaining regulatory oversight functions across Ohio Health research sites.

The person in this position provides compliance oversight and guidance and communicates and interprets agency policies and requirements for research personnel. This includes acting to improve internal processes when possible, follow-up and management of research files.

Responsibilities And Duties:

30% Project coordination works with research nurses and physicians to implement study procedures; consult with principal investigator in project decision-making; assigns work to project staff; orients and instructs investigators and staff on data collection and project record-keeping procedures. Ensures investigators have undergone RMH-required education on research regulations. Maintains and stores confidential data collection forms, proposals, and final reports in accordance with the hospital's research policies.

Acts as a Liaison with the trial sponsor during the regulatory submission process, collects, organizes, logs, files and transmits all required site & investigator documents. Initiates new research protocol regulatory files in compliance with department SOPs and the Federal Code of Regulations. Acts as a resource to clinical research staff on research regulatory concerns. May be asked to internally audit projects to ensures studies are conducted in accordance with federal regulations related to human subjects' research.

Prepares, maintains, and updates computerized database pertaining to research patients.

20% Project Planning facilitates multidisciplinary research team; assesses feasibility of research projects; designs data collection processes. Reviews project proposals for completeness and appropriate formatting. Conducts initial review and dissemination of research protocols, protocol revisions, protocol amendments and obtains opinions from others, when appropriate.

50% Liaison with Institutional Review Board on ethical matters regarding hospital-sponsored human subjects' research; responds to IRB correspondence and determination letters. Prepare proposals applications and submissions to the appropriate institutional review board. Responds to requests for information which originate from other hospital departments, investigators and outside sponsors concerning status of IRB approval.

Quality and Compliance Assists in audit preparedness activities for OHRI. Assists with monitoring visits on site and remotely and is available during visits for corrections, questions, etc. Maintains study records according to sponsor and/or regulations. Keep records in a secure location.

Reporting Assist in the development of reporting metrics. Generates reports and reviews to ensure accuracy. Provide ad hoc reports.

Communication Demonstrates effective…