By applying a comprehensive understanding of research regulations & ethical principles, analyze submissions (proposed new studies, amendments, & adverse events) for compliance with regulations & CCHMC policies governing the protection of human subjects in research. Oversee the review & approval of highly complex human research protocols. Use independent and, when appropriate, collaborative judgment to interpret, analyze, & apply federal regulations; state & local law; & CCHMC policies to promote ethical practices in research involving human subjects & to ensure compliance to those regulations by faculty & staff investigators. Identify & manage risk, including planning & implementing corrective actions to ensure the protection & safety of subjects & to meet cost, time & quality performance requirements.
Serve as a resource for the institution & investigators to develop & implement a regulatory submission strategy from pre-pre-IND through IND & device submissions. Provide leadership for the overall direction, coordination, implementation, execution, control & completion of early phase FDA submissions, ensuring consistency with regulatory strategy & requirements & project goals. Interact with the research faculty & staff from a service-oriented approach. Answer questions & problem solve for investigators, faculty, staff, & research support staff. Act as a liaison between IRB/regulatory staff, CCRF Core research facilities, other institutions, & researchers to promote information flow in a timely manner. Prepare, review, & submit all protocol amendments, SAE reports, & continuing reviews in a timely manner, meeting all deadlines.
Work directly with individual faculty & staff investigators & research support staff to address human subject issues during protocol review. Facilitate research by assisting investigators with highly complex studies through the regulatory process by being able to determine regulatory issues that impact upon proposed research studies, develop & review draft or sponsor-provided documents, & advise investigators & research coordinators regarding potential ethical, regulatory, editorial or content issues before they are submitted for IRB or regulatory agency review.
Determine which research protocols or issues have additional requirements, such as the need for review by additional CCHMC Division, regulatory agency, or consultant, & coordinate the process to meet these requirements. Organize & 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 & resolution. Follow policies & procedures governing the handling of confidential information as defined by Cincinnati Children's mission & applicable laws & regulations. Review timeliness, accuracy, availability & security of information.
Provide guidance to & help investigator to assemble documentation to ensure that pre-pre-IND, pre-IND & 510k documents are complete to enable a productive outcome of the pre-pre-IND, pre-IND, & medical device meetings with the FDA. Document meeting notes & ensure proper follow up with the agency. Pre-pre & pre-IND documentation may include research strategy & timeline, scale up plans, & animal study plans. Work with other Cores such as the Cell Manipulation Lab, the Viral Vector Core & Production Facility to ensure complete GLP-lite & GMP-lite documentation. 510k documentation may include design control activities, risk analysis & declaration of conformity. Document the conduct of each protocol's regulatory activities in appropriate systems. Maintain written & electronic systems to support clinical research activities. Submit data to collaborative parties accurately & within a timely manner.
Work daily in an 'audit ready' manner. Lead activities to prepare for audits, surveys, quality reviews, & inspections. Document, organize, & maintain all correspondence with Investigator/Sponsor/IRB/regulatory agencies/other relevant groups in audit-ready state in electronic & hard-copy format. Periodically self-audit records to ensure audit-ready. Prepare, plan, & participate in all monitor visits, audits, & quality reviews (internal & external) in a professional manner Participate in improving organizational performance through recommending areas or approaches for improvement activities, performing new procedures, collecting data & providing input to department discussions. Participate in establishing job requirements & goals; perform duties at the desired level of competency. Identify, lead, & direct process/quality improvement/assurance activities. Measure & present results of improvement efforts & ongoing performance measures of processes. In collaboration with appropriate individuals, develop strategic plans for improvement. May manage activities such as training & audits which support process improvement initiatives/activities. May participate on process improvement team(s).
Act as a resource for CCHMC Investigators regarding regulations, optimal FDA submission pathways & CCHMC policies during research protocol review. Communicate analysis to Investigators. Serve as an informational & referral resource for CCHMC research community regarding regulatory, ethical & procedural issues. Maintain currency in field through cross-training, continuing education, literature & seminars. Implement this knowledge into the OCTR office. Disperse knowledge gained to others through in-services or training sessions.
Demonstrate advanced competence in drug, diagnostic, therapeutic & device submission pathway knowledge, & effectively communicate with the FDA, & with investigator, study team members & collaborators. Contribute to investigator & study team member growth by sharing knowledge, experience, & skills; stay abreast of changes in federal & local regulations; serve as an expert resource for the institution & to investigators who are working on early phase projects. Communicate the results of meetings & correspondence with the FDA, IRB/regulatory review to investigators, sponsors, coordinating centers, study coordinators, & managers by phone, e-mail, in person, or in written correspondence in a timely fashion. Compose clear, precise, detailed & technical letters & correspondence.
Excellent verbal, written & interpersonal communication skills.
Advanced knowledge & analytical ability sufficient to evaluate data, make judgments & recommendations regarding projects, budgets & milestones, & generate well developed business reports.
Astute in analyzing situations & assessing group dynamics. Superior influencing skills & diplomacy in working with all levels of leadership.
Working knowledge of the principles & concepts of project management including proficiency with tools used in development, planning & execution of project plans.
Demonstrated knowledge of all phases of the clinical research process & related regulatory requirements.