By applying a comprehensive understanding of research regulations and ethical principles, analyze submissions (proposed new studies, annual review, amendments, and adverse events) for compliance with regulations and CCHMC policies governing the protection of human subjects in research. Oversee the review and approval of human research protocols. Use independent and, when appropriate, collaborative judgment to interpret, analyze, and apply federal regulations; state and local law; and CCHMC policies 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 subject issues during protocol review. Facilitate research by assisting investigators through the regulatory process by being able to determine regulatory issues that impact upon proposed research studies, develop and review draft or sponsor-provided documents, and advise investigators and research coordinators regarding potential ethical, regulatory, editorial or content issues before they are submitted for IRB or regulatory review. Interact with the research faculty and staff from a service-oriented approach. Answer questions and problem solve for investigators, faculty, staff, and research support staff. Act as a liaison between IRB/regulatory staff and researchers to promote information flow in a timely manner. Prepare, review, and submit all protocol amendments, SAE reports, and continuing reviews in a timely manner, meeting all deadlines.
Determine which research protocols or issues have additional requirements, such as the need for review by additional CCHMC Division, regulatory agency, or consultant, and coordinate the process to meet these requirements. Organize and communicate the analysis of the research protocol to the Investigator/IRB/ regulatory agency/coordinating centers in a variety of modalities: within the protocol regulatory record, in e-mail communications, in written format to the Investigator/IRB/ regulatory agency/coordinating center. Clearly summarize controversial issues and resolution. 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 appropriate systems. 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. Lead activities to prepare for audits, surveys, quality reviews, and inspections. Document, organize, and maintain all correspondence with Investigator/Sponsor/IRB/regulatory agencies/other relevant groups in audit-ready state in electronic and hard-copy format. Periodically self-audit records to ensure audit-ready. Prepare, plan, and participate in all monitor visits, audits, and quality reviews (internal and external) in a professional manner.. 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 establishing job requirements and goals; perform duties at the desired level of competency.
Act as a resource for CCHMC Investigators regarding regulations and CCHMC policies during research protocol review. Communicate analysis to Investigators. Serve as an informational and referral resource for CCHMC 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 division/department. Disperse knowledge gained to others through in-services or training sessions
Communicate the results of IRB/regulatory review to investigators, sponsors, coordinating centers, study coordinators, and managers by phone, e-mail, in person, or in written correspondence in a timely fashion. Compose clear, precise, detailed and technical letters and correspondence.
Participate in special projects, workgroups and other responsibilities as an engaged team member. Participate in CCHMC-wide project groups related to the research regulatory compliance and protection of human subjects at CCHMC. This may include meeting attendance, research and writing, preparing and distributing materials, recording minutes to document progress, and communicating the final outcome. Apply 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 and research support staff. Contribute to planning and presenting educational programs for investigators, research support staff, and other groups
Excellent interpersonal skills required.
Excellent writing, editing and related computer skills
·MS Office - Intermediate
Proficient in Microsoft Office programs
·PowerPoint - Advanced
Advanced skill in MS PowerPoint
Strong organizational and project management skills to handle projects independently.
·Analysis - Basic
Analytical ability sufficient to evaluate data, make judgments and recommendations
Ability to independently work through details of a problem to reach a positive solution
·Knowledge of Regulations
Knowledge of the code of federal regulations regarding human subject research or research experience with human subjects required