University of Rochester Sr Health Project Coord in Rochester, New York
Full Time 40 hours Grade 055 Surgery- Cancer Control
Serves as the Audit and Regulatory Compliance Program Manager for the NCI Community Oncology Research Program (NCORP) Research Base and the Dept. of Surgery Cancer Control & Survivorship Research Program (CCSRP). Functioning independently and with significant latitude for independent judgment, provides oversight of regulatory activities and clinical research quality assurance and quality improvement for the NCORP Research Base and the Dept. of Surgery CCSRP.
Working closely with multiple Principal Investigators in the NCORP Research Base, oversees all regulatory activities involved in implementing and coordinating multi-site cancer control research, and meeting federal and university reporting requirements for research activities. The Audit and Regulatory Compliance Program Manager will be the Head Auditor for the NCORP Research Base and will direct auditing activities at the 20+ affiliated sites. Excellent interpersonal skills are required, as the individual must interface with faculty and staff both within the University and at multiple outside affiliates, as well as program leaders and staff at NCI. This position has responsibility for creating and maintaining a foundation of best practices, acts as the liaison between research staff (PI and study management team) and the NCI’s Clinical Trials Monitoring Branch (CTMB), the NCI Central IRB, the University’s Research Subjects Review Board (RSRB), and Wilmot Cancer Institute’s (WCI) Data Safety and Monitoring Committee (DSMC).
Audit and Quality Assurance/Improvement
- As the Head Auditor for the NCORP Research Base, this position is responsible for all auditing activities, including monitoring of investigative sites and site compliance with clinical trial protocols and Good Clinical Practice, through on-site visits and remote means via electronic data capture system
- Develops schedule of monitoring visits to 20+ off-site affiliates of the NCORP Research Base in accordance with CTMB Guidelines; notifies sites; assembles audit teams; arranges details of the visit; prepares materials; reviews all regulatory documentation, consent forms and drug accountability records; compiles subject cases to be audited; and prepares forms and checklists
- Attends and leads off-site audits to ensure research activities are in accordance with the NCI CTMB Guidelines, e.g., verify that data reported in research records complies with protocol requirements; verifies study materials accountability records and regulatory records on-site
- Serves as the liaison between internal and external study personnel, investigators, the WCI Peer Review Committee, the RSRB and the NCI’s CTMB in all phases of auditing and monitoring of clinical research for the NCORP Research Base.
- Prepares and submits comprehensive electronic audit reports to NCI CTMB as required
- Reviews all monitoring reports submitted by other auditors and communicates with investigators and research staff at sites regarding follow up
- Reviews and reconciles serious adverse events and other reportable events received and ensures proper documentation in study records; distributes to investigators, NCI, RSRB, DSMC as needed; maintains detailed adverse event database for each protocol,
- Serves as the NCORP Safety Monitor, preparing detailed reports for the WCI DSMC and attending their quarterly meetings.
- Updates URCC NCORP Research Base Audit Guidelines to ensure compliance with CTMB Guidelines and NIH/NCI funding requirements.
- Responsible for oversight and compliance of Health Project Coordinators with federal and local regulations; develops corrective and preventative action plans for noncompliance.
- Develops and updates standard operating procedures for NCORP Research Base to ensure compliance with NIH/NCI funding requirements.
- Oversees the central file development, collection, tracking and storage of regulatory documents required for clinical trials, e.g., FDA 1572, IRB approval etc. for NCORP protocols.
- Follows NIH/NCI (or other granting agency) and CIRB/RSRB regulations to meet application and reporting requirements, and ensures regulatory compliance throughout conduct of study.
- Assists investigators in preparing, submitting, tracking and responding to IND requirements, where applicable, including safety and ongoing reporting.
- Provides expertise during weekly Study Management meetings at all stages of the study (e.g., during study development, at implementation, throughout conduct of study, at closeout) to ensure all regulatory requirements are addressed from study development throughout the life of the study) to ensure appropriate conduct.
- Assists principal investigators in the development of research protocols and consent forms to ensure that all protocols comply with regulatory requirements of NCI, FDA and IRB.
- Assists in study startup processes, including development of monitoring plan, site investigator and staff training, regulatory compliance with IRB, FDA, etc.
- Works closely with investigators and study coordinators at off-site NCORP affiliates to ensure regulatory compliance of NCORP studies.
- Maintains expert knowledge and keeps current in regulatory compliance by reviewing relevant literature, visiting websites (NIH, ORPA, RSRB), and attending pertinent meetings and seminars.Presents new regulatory information as applicable to both internal and external groups
- Serves as the primary regulatory liaison and resource for CCSRP investigators and clinical research coordinators.
- Trains new faculty and staff in Good Clinical Practice and standard operating procedures of the NCORP Research Base.
- Supervise 2 Regulatory Compliance Specialists who manage site and personnel rostering documentation and requirements of multiple NCORP affiliates, process concepts, protocols, and amendments, and track site approvals.
- Perform other project coordination activities as directed by the Research Program Administrator and investigators.
Bachelor’s degree, with major course work in appropriate health, social science, or biological science field and at least 3-5 years of clinical trials related experience; or equivalent combination of education and experience. Knowledge of Good Clinical Practice, protocol planning, implementation, coordination, evaluation, and reporting of clinical trials. Management and clinical trials monitoring experience preferred. Requires frequent travel across the US. Strong communication skills and attention to detail required.
EOE Minorities/Females/Protected Veterans/Disabled
Job Title: Sr Health Project Coord
Location: School of Medicine & Dentistry
Job ID: 207832
Full/Part Time: Full-Time