The Protocol Review Specialist coordinates all aspects of the NCI required NCCC Clinical Cancer Research Committee (CCRC), the NCCC Population Sciences Sub-Committee (PSS), and the Data Safety Monitoring and Accrual Committee (DSMAC). Provides activation support for PIs developing investigator initiated (IIT) clinical trial protocols including protocol editing and navigation through the study activation review processes.
Interested candidates can apply by emailing Erin E. Lynch
[email protected] with both their resume (PDF format) and salary requirements.
Responsibilities
· 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.
Qualifications
· 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.
Range: $69K – 84K annual