Fully Remote if residence outside of VT/NH states.
Email resume to sean.hobson@hitchcock.org
The Senior Manager Research Operations provides expert-level knowledge and supports service line and system wide assessments, monitoring, oversight, and education for effective regulatory and risk-mitigation programs. Regulatory areas include service line relevant regulatory commitments with federal, state and hospital disclosure requirements, human subjects protection, animal subjects protection, and responsible conduct in research. Provides regulatory leadership, guidance, training and awareness materials across at least five Dartmouth Clinic sites.
Provides umbrella oversight of any service line project that requires a filing with national boards or committees (i.e., Institutional Research Board (IRB)/ Committee for Protection of Human Subjects (CPHS), etc.), and assures compliance with the Food and Drug Administration (FDA), Good Clinical Practice (GCP) research standards, JCAHO and Internal Conference on Harmonization (ICH) guidelines as appropriate. Provides a forum for review and vetting of new protocols and the progress of existing protocols and monitors enrollment and finances of existing trials.
Responsibilities
Service line representative for at least five Dartmouth Clinic sites regarding regulatory and compliance matters, addressing inquires and action plan development.
Operations representative to consult and participate in workflow mapping for system wide research systems such Advarra EDC and Oncore.
Administrator and core contributing member of Advarra eReg system, where scope may include facilitating upgrade work, supporting various sites within the research community with the use of the system, and producing essential training materials
Develops benchmarks and training for complex service line relevant research topics across at least five Dartmouth Clinic sites. Is a resource to research professionals and investigators. Provides research regulatory and compliance leadership, guidance, education, and supports policy development.
Leads the development of operational and strategic documentation for study activation and decentralized clinical trials.
Designated institutional representative and contact person for Clinical Trial Network Groups, manages the full spectrum of service line membership to NTCN and other national cooperative groups to ensure compliance and accurate reporting.
Service line lead and task owner responsible for internal and external audit preparation and action planning post review for at least five Dartmouth cancer center sites.
Oversees a repository of service line standard operating procedure documents, lead for composing new relevant regulatory SOPs, benchmarking service line SOPs against other academic medical centers, continual update of existing service line SOP documents and communication of updates to senior leadership.
Supervises all assigned clinical research personnel either directly or via supervisory staff. Provides leadership in mentoring new and current clinical research staff, staff training in department research and administrative procedures, performance evaluation, and encouragement and support of personal and professional development.
Service line designee to sit on service line and system wide committees focused on research policies and IDS related guidelines and queries.
Provides leadership and direction to Fellows, Principal Investigators, and research staff in maintaining compliance with applicable state and federal regulations. Monitors adverse events and reports serious events to appropriate agencies, committees or boards as well as to sponsor(s) per study requirements.
Ensures proper workload distribution and back up support for each research team member and develops and encourages standardization of processes and procedures.
Serves as liaison with participating clinical centers throughout North America and with applicable agencies, committees, boards (i.e., IRB/CPHS, the NIH, and the FDA, etc.) regarding adverse events, study initiations, study revisions, study enclosures, etc.
Performs other duties as required or assigned.
Bachelor’s degree with 7 years of relevant experience in a healthcare field related to the specific area of research, or the equivalent in education and experience required.
Possess a minimum of three years of supervisory experience in a research setting.
Experience at an academic, research, or hospital setting (such as grants management, clinical trial management, or research administration).
Strong knowledge of federal, state, and sponsor regulations regarding the conduct of clinical trials, including investigator-initiated trials, the informed consent process, trial congruency, and protection of human subjects.
Project and program management skills. Demonstrated ability to lead working groups to achieve results.
The Office of Clinical Research (OCR) is the established office in the Dartmouth Cancer Center (DCC) which supports the clinical cancer research program. The OCR provides support for investigator-initiated trials (IIT), cooperative group trials (Full Member of ALLIANCE, NRG, CITN), and corporate-sponsored studies. The mission of the OCR is to assist with the planning, conduct and compliance of clinical trials involving cancer treatments and care, and to provide regulatory support for population science studies as well.
The OCR assures the highest quality of research and adherence to relevant regulations by primary coordination of the study and review of research compliance. In the past two years (2020-2021), there have been 1272 enrollments to interventional trials and 4336 enrollments to non-interventional (including ancillary/correlative studies) trials. The OCR also supports enrollment to numerous tissue banks, including Melanoma, Neuro-Oncology, and Hematology groups. The OCR staff assists PIs with all aspects of protocol development, activation, implementation, conduct, and study data analysis. Prioritization of clinical studies for DCC patients is done through the Clinical... Oncology Groups (COGs) and is required prior to submission to the Clinical Trials Review Committee, a submission that is also prepared by OCR staff. Independent peer-review by the CCRC, monitoring of cooperative group protocols, and review of safety are facilitated by the OCR, thereby minimizing potential conflicts of interest, enhancing protection for human subjects and assuring confidence in the quality and integrity of our research.