Clinical Research Support (CRS) Medical Director
Fred Hutchinson Cancer Research Center
The Clinical Research Support (CRS) Medical Director will work in partnership with the administrative Director of CRS to set the strategic direction of the Cancer Consortium’s clinical research infrastructure. The incumbent will serve as the primary faculty representative on clinical research-related initiatives across Fred Hutch, the University of Washington (UW), Seattle Children’s and the Seattle Cancer Care Alliance (SCCA) and will provide direction to the Consortium’s clinical trials office, CRS. CRS currently provides support for over 400 clinical research staff and faculty, and over 600 active clinical trials and 1,500 clinical research studies. CRS is responsible for ensuring the efficient review, approval, and implementation of cancer clinical research throughout the Cancer Consortium. CRS ensures high quality, regulatory compliant clinical research through quality control functions including trial monitoring and auditing, training, and policy development.
The incumbent will dedicate 40% effort to the CRS Medical Director position; the remaining effort will be allocated to clinic service and academic pursuits including teaching and research. The CRS Medical Director reports to the Cancer Consortium Director or Deputy Director as designated.
• Work directly with the Consortium Director to inform clinical research strategic goals and ensure that the Consortium’s clinical research infrastructure is aligned to support these goals.
• Provide leadership to promote central oversight of study teams and help identify models that provide efficient division of responsibilities between CRS and study teams.
• Work closely with CRS administrative Director to ensure that CRS meets the NCI requirements of the Clinical Protocol and Data Management (CPDM) functions; in collaboration with Consortium partners, ensure that the overall Consortium clinical research infrastructure meets the NCI expectations of a Comprehensive Cancer Center.
• Serve as primary point-of-contact for faculty communications regarding CRS and Consortium clinical research infrastructure; work closely with Research Group Directors to stay abreast of clinical research-related issues as they arise.
• Escalate compliance issues and corrective and preventative action plans to PIs, leadership and the Clinical Research Oversight Committee (CROC) as appropriate; serve as faculty representative on the Compliance Sub-committee.
• Advise CRS Quality and Compliance on new policies and processes; provide interpretive support of new federal, state and local regulations.
• Represent faculty interests on Consortium improvement efforts and communicate potential impacts back to faculty.
• Ensure Consortium is compliant with ClinicalTrials.gov result reporting; ensure that sufficient resources are available to faculty.
• Provide direction and oversight to CRS-led faculty trainings.
• Collaborate with faculty and administrative leadership across Consortium partner institutions to ensure alignment of resources and priorities where appropriate, including:
o Serving as faculty advisor to the UW’s Institute of Translational Health Sciences, a Clinical and Translational Science Award (CTSA) Program;
o Liaising with Seattle Children’s oncology programs to ensure efficient integration with CRS and other Consortium functions;
o Advocating research integration into the clinical sites of practice across the Consortium including the UW and SCCA; and
o Working with the SCCA’s Network Research Office Medical Director to vet new Network sites and physicians for clinical trial participation.
Committee Membership Requirements:
Institution-Sponsored IND Oversight Committee, Member (quarterly)
Compliance Sub-committee, Chair (monthly)
Consortium IRB Chair Liaison Committee, Chair Liaison (monthly)
Clinical Research Oversight Committee, Member (quarterly)
Experience and Attributes:
• Experience and knowledge in conducting intervention clinical trials
• Knowledge of applicable FDA and ICH GCP regulations
• Proven ability to lead faculty
• Works collaboratively with faculty and administration
• Ability to lead change by influence across organizations
• Strong written and verbal communication skills
• Skilled in identifying and appealing to motivations for change among diverse stakeholders
Interested candidates please apply online: www.fredhutch.org/job/8988