Protocol Review Specialist
Norris Cotton Cancer Center (NCCC)
The Protocol Review Specialist coordinates all aspects of the NCI required Protocol Review and Monitoring System (PRMS) and Data Safety Monitoring (DSM) committee activities. These include the Clinical Cancer Research Committee (CCRC), and the NCCC Population Sciences Sub-Committee (PSS), and the Data Safety Monitoring and Accrual Committee (DSMAC) at the Norris Cotton Cancer Center. The Specialist additionally provides support for PIs developing investigator initiated (IIT) clinical trial protocols including protocol editing and navigation through the study activation review processes.
· Acts as a liaison between the CCRC, PSS, and DSMAC Committee Chairs and investigators and their research teams.
· Independently pre-reviews committee submissions and works with investigators to meet Committee expectations.
· Continuously monitors and tracks key study metrics (e.g. number of reviews, decisions, study types, funding sources, unique studies). Generates and submits reports to NCCC Administration.
· Provides consultative guidance to investigators regarding necessary protocol elements, regulatory language requirements, as well as organization and guidance for the content and format expectations of the CCRC.
· Prepares and distributes meeting materials, and takes minutes at Committee meetings and prepares reviewer critique feedback for investigators.
· Facilitates reviewer critique feedback to investigators (e.g. study design, scientific validity, treatment considerations, statistical considerations, laboratory studies of biologic endpoints, toxicity management, accrual and institutional commitment considerations).
· Drafts correspondence to investigators regarding Committee decisions to support with follow-through of action items.
· Assists OCR Regulatory & Compliance Officer with audit readiness planning and response coordination. Works with study teams to assist in the development of internal audit/monitoring responses including appropriate corrective and preventative actions.
· In partnership with Research Quality and Study Coordinators reviews and supports the development of corrective and preventative actions.
· Performs other duties as required or assigned.
· Bachelor’s degree strongly preferred with 5 years of clinical research experience, or the equivalent in education and experience, required. Oncology research experience preferred.
· Experience in the development of corrective and preventative action.
· Advanced knowledge of clinical trials.
· Ability to understand and follow complex scientific and medical discussions.
· High attention to detail and accuracy.
· Demonstrated ability to organize data and present reports to varying levels of leadership and stakeholders.
· Strong proficiency with word processing, spreadsheet software, systems management and data entry.
Required Licensure/Certification Skills:
· Certification through the Society of Clinical Research Associates or Association of Clinical Research Professionals preferred.
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.
Candidates are requested to apply online
, Req #190000EZ:
For more information, please contact:
Senior Talent Acquisition Specialist
Dartmouth-Hitchcock is an equal opportunity employer.