The Research Program Manager coordinates and/or manages all aspects of complex, multi-component research projects, general research and projects for the assigned service line. Manages activities related to regulatory compliance and staff training, project contracts, budgets, and all related research finances, workforce needs throughout the research group, maintenance of databases and coordination with the Office of Sponsored Projects for any state or federally funded studies. Provides oversight of any 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.
Ensures quality and success of clinical research endeavors.
Leads the development of operational and strategic plans for the assigned organization’s research group in alignment with established research policy.
Supervises all assigned clinical research personnel either directly or via supervisory staff.
Convenes regular research / advisory committee meetings where proposed protocols are presented to the group and decisions are made whether to accept or include a study based on business and scientific evidence.
Works with the Clinical Trials Office (CTO) and study Principal Investigators (PI) to develop, manage and monitor clinical trial contracts and budgets.
Organizes and manages clinical trials and other research studies/projects, including recruitment strategies, workflows, document creation and guidance, management tools, site visit tasks, and regulatory documentation maintenance and distribution in conjunction with PIs.
Provides leadership and direction to Fellows, Principal Investigators, and research staff in maintaining compliance with applicable state and federal regulations.
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.) with regard to adverse events, study initiations, study revisions, study enclosures, etc.
Bachelor’s degree with 5 years of relevant experience in a healthcare field related to the specific area of research, or the equivalent in education and experience required. Master’s degree preferred.
Excellent organizational, writing, and office software skills required.
Prior supervision experience preferred.
Required Licensure/Certification Skills:
Certification through the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) required, and/or obtained during the first two (2) years of employment.
The Dartmouth-Hitchcock health system stretches over New Hampshire and Vermont and offers the quintessential New England experience. With no income or sales tax, this beautiful area combines history, industry and business and has been ranked consistently as one of the best places in the US to live and work. With destinations like Boston, New York, the seacoast and ski country within driving distance, the opportunities - both career and personal - truly make New Hampshire the ideal place to work and play.
Applicants are encouraged to apply online, Req #180001PV:
Dartmouth-Hitchcock is an equal opportunity employer.
Internal Number: 180001PV
How can the lifestyle in New Hampshire and Vermont compliment your career? You can have amazing 4-season living with a career at one of the top health systems in the country. The Dartmouth-Hitchcock health system stretches over New Hampshire and Vermont and offers the quintessential New England experience. With no income or sales tax, this beautiful area combines history, industry and business and has been ranked consistently as one of the best places in the US to live and work. Anchored by the academic Dartmouth-Hitchcock Medical Center in Lebanon, NH, the system includes the NCI-designated Norris Cotton Cancer Center, the Children's Hospital at Dartmouth-Hitchcock; 4 affiliated hospitals and 30 Dartmouth-Hitchcock ambulatory clinics across the region. We are close to the urban centers of Boston, New York and Montreal, but also offer proximity to the seacoast and multiple top-tier ski mountains within a short driving distance. Throughout New Hampshire, the opportunities – both career and personal – truly make our area the ideal place to work and play.Dartmouth-Hitchcock is an equal opportunity employer and all qualified applicants will receive consideration for employment without ...regard to race, color, religion, gender, national origin, disability status, veteran status, or any other characteristic protected by law.