Specialist-Regulatory Affairs – Heart Institute Administration
POSITION TITLE: SPECIALIST-REGULATORY AFFAIRS
DEPARTMENT: Heart Institute
COLLABORATIVE RELATIONSHIPS: Clinical Investigators from CCHMC and Other Institutions; Sponsors of Clinical Investigations; CCHMC Institutional Review Board; Central IRBs; Coordinating Centers for Cooperative Group Clinical Trials; Supporting Government Agencies; Faculty; Research Coordinators; Research Nurses; Federal Regulatory Organizations such as the Food and Drug Administration and Office of Human Research Protections; CCHMC Office of Research Compliance and Regulatory Affairs; Sponsored Programs; Center for Technology Commercialization; Clinical Translational Research Center; Legal Department; Pediatric Informatics.
SUPERVISOR’S TITLE: Clinical Research Manager; Business Director; Medical Director
PURPOSE OF POSITION: To oversee the review and correspondence of research protocols to the Institutional Review Board for the Research Administration of a Medical Center dedicated to the care of infants; children and adolescents.
Apply a comprehensive understanding of research regulations, ethics and guidelines, analyze research protocols submissions (new protocols, continuing review, changes to protocols, one-time use request and adverse events) to determine compliance with regulations. Oversee the review and correspondence of research protocols. Use independent judgment to interpret, analyze, and apply federal, state and CCHMC guidelines to promote ethical practices in research involving human subjects and to ensure compliance to those regulations by faculty and staff investigators. Work directly with individual faculty and staff investigators and research support staff to address 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. Prepare, review and submit all protocol amendments, SAE reports, and continuing reviews. Complete all reviews and submissions in a timely manner, meeting all deadlines.
Upon request from investigators, conduct 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. Determine 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 Oncore�. Maintain written and electronic systems to support the clinical research activities. Submit data to collaborative parties accurately and within a timely manner.
Work daily in an ‘audit ready’ manner. Organize and participate in activities to prepare 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 staff committee, subcommittee, or special project groups. This may include research and writing, coordinating meeting schedules, preparing and distributing materials, recording minutes to document progress, and communicating the final outcome. By applying a comprehensive understanding of research and ethics, compose clear and precise memos, reports and training materials. Assist in developing written guidelines and educational materials for investigators (faculty and staff). Contribute to planning and presenting educational programs for investigators, research coordinators, and other groups. Use creative and effective presentation skills. 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 cross-training, continuing education, literature and seminars. Implement this knowledge into the department.
Communicate the results of IRB review to investigators and study coordinators by phone, e-mail, in person, or in written correspondence in a timely fashion. Compose clear, precise, detailed and technical letters and correspondence.
·Bachelor’s Degree OR Equivalent combination of education and experience
·Three years directly related experience
Locating and gathering relevant information; recognizing and working to eliminate important gaps in existing information; determining the value of the information; synthesizing and organizing information to get a better understanding of a problem
Knowledge of regulations, procedures and best practices in field
Proficiency in basic computer applications such as Microsoft Office (PowerPoint, Word, Excel), e-mail, and internet
Strong organizational and project management skills to handle projects independently.
Ability to independently work through details of a problem to reach a positive solution
Working knowledge of research methods including measurement, data collection and validity issues
Excellent verbal, written and interpersonal communication skills.
Job posted: 2020-05-14