Cancer Center Jobs

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

1. Service line representative for at least five Dartmouth Clinic sites regarding regulatory and compliance matters, addressing inquires and action plan development.

2. Operations representative to consult and participate in workflow mapping for system wide research systems such Advarra EDC and Oncore.

3. 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

4. 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.

5. Leads the development of operational and strategic documentation for study activation and decentralized clinical trials.

6. 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.

7. 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.

8. 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.

9. 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.

10. Service line designee to sit on service line and system wide committees focused on research policies and IDS related guidelines and queries.

11. 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.

12. Ensures proper workload distribution and back up support for each research team member and develops and encourages standardization of processes and procedures.

13. 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.

14. Performs other duties as required or assigned.

Qualifications

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.

Required Licensure/Certifications

Possess certification through the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP), Regulatory Affairs Professional Society (RAPS), or PRIM&R or the Society of Clinical Research Associates (SOCRA) is required and/or obtained during the first year (1) year of employment.

Don't meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Dartmouth Hitchcock Medical Center and Clinics, we are dedicated to building a diverse, inclusive and authentic workplace, so if you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyway. You may be just the right candidate for this or other roles.