Full Job Title: OCTR Off for Clin&Transl Rsch - Regulatory Affairs Coordinator
Job Number: 90150
Location: Cincinnati, OH
Date Posted: 4-27-2017
POSITION TITLE: COORDINATOR-REGULATORY AFFAIRS
SUPERVISOR'S TITLE: Varies
COLLABORATIVE RELATIONSHIPS: Office of Research Compliance and Regulatory Affairs, Faculty, Research Coordinators and Research Nurses, IRB Members, Industry partners, Sponsored Programs, General Clinical Research Center, Office of Risk Management, HIPAA Compliance Office, Radiation Safety Committee, Gamble Program for Clinical Research, Cincinnati Center for Clinical Research, Bioethics Committee, Pediatric Informatics.
PURPOSE OF POSITION: To assist in the review, processing, and correspondence of research protocols to the Institutional Review Board and other review committees for the research administration of a Medical Center dedicated to the care of infants, children and adolescents.
Apply a basic understanding of research regulations, ethics and guidelines, assist in the analysis of research protocols submissions (new protocols, continuing review, changes to protocols, one-time use request and adverse events) to determine compliance with regulations and institutional policies. Work directly with Supervisor, other research support staff, and individual faculty and staff investigators and to assist in the resolution of human subjects issues during protocol review. Answer questions and problem solve for investigators, faculty, staff, research coordinators and students. Act as a liaison between IRB members and researchers to promote information flow. Assist in the preparation, review and submission of all amendments, SAE reports, and continuing reviews. Complete all reviews and submissions in a timely manner, meeting all deadlines.
Assist in the conduct of pre-reviews of draft documents (such as new protocol submissions, exemptions, and changes of protocol) and advise investigators and research coordinators regarding potential ethical, regulatory, editorial or content issues before they are submitted for full IRB review. Assist in the determination which research protocols or issues have additional requirements, such as the need for review by an outside expert, and coordinate the process to meet these requirements. Follow policies and procedures governing the handling of confidential information as defined by Cincinnati Children's mission and applicable laws and regulations. Review timeliness, accuracy, availability and security of information.
Document the conduct of each protocol's regulatory activities in EPAS or other departmental databases. Maintain written and electronic systems to support clinical research activities. Submit data to collaborative parties accurately and within a timely manner.
Work daily in an 'audit ready' manner. Assist in preparation activities for audits, surveys, quality reviews, and inspections. Participate in improving organizational performance through recommending areas or approaches for improvement activities, performing new procedures, collecting data and providing input to department discussions. Participate in special projects, workgroups and other responsibilities Participate in staff committee, subcommittee, or special project groups of the department. This may include basic research and writing, coordinating meeting schedules, preparing and distributing materials, recording minutes to document progress, and communicating the final outcome. Assist in developing written guidelines and educational materials for investigators (faculty and staff). Contribute to planning, presenting, and tracking educational programs for investigators, research coordinators, and other groups. Participate in establishing job requirements and goals; perform duties at the desired level of competency.
Act as a resource for faculty and staff regarding regulations during research protocol review. Serve as an informational and referral resource for the research community regarding regulatory, ethical and procedural issues. Maintain currency in field through continuing education, literature and seminars. Implement this knowledge into the CMRSC activities.
Communicate the results of IRB review to investigators and study coordinators by phone, e-mail, in person, or in written correspondence in a timely and professional fashion. Compose clear, precise, detailed and technical letters and correspondence.
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