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. Oversees the work of others. 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. Serves as a resource to team members.
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 Oncore?. Maintain written and electronic systems to support the CBDI 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 special projects, workgroups and other responsibilities as an engaged team member. Participate in CBDI, CCHMC-wide, and Cooperative Group project groups related to the research regulatory compliance and protection of human subjects at CCHMC.
Act as a resource for CBDI and CCHMC Investigators regarding regulations and CCHMC policies during research protocol review. Communicate analysis to Investigators. Serve as an informational and referral resource for the CBDI and 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 CMRSC office. Disperse knowledge gained to other members of the CMRSC through in-services or training sessions. Assume a leadership role on committee &/or work group affecting the division, medical center &/or community. Act as a role model with a significant expertise, knowledge & experience.
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.
Actively contribute to a positive work environment. Serve as a resource for others regarding all aspects of the preparation, review and maintenance of research protocols, and the submission process. Collaborate effectively with others to ensure proper progress & completion of assigned work. Train new staff in all aspects of their role. Actively participate in ongoing staff development. Contribute to the professional growth of others. Provide a leadership role in research management, compliance and quality improvement. Assist other members by educating, providing resources, & consulting on difficult work issues or projects. Indirectly (or directly) supervise lower levels. Effectively collaborates with others.
Considering multiple perspectives or challenging traditional assumptions; formulating unusual, clever ideas or developing new insights; astutely identifying new ideas that will improve organizational functions, products, or services
·Knowledge of Field - Intrm
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
·Research Methods - Basic
Working knowledge of research methods including measurement, data collection and validity issues
·Communication - Advanced
Excellent verbal, written and interpersonal communication skills.