Please apply to this position at:
https://careers-fhcrc.icims.com/jobs/29667/clinical-research-iit-program-director/job
Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.
The Clinical Research IIT Program Director (Investigator-Initiated Trial) is primarily responsible for strategy and operational management of protocol development, project management and data management for IITs in our oncology clinical trials portfolio.
The incumbent manages the lifecycle of IITs from Letters of Intent (LOI), feasibility, protocol writing, database design, coordinates financial and operational startup, amendments, to data analysis and publication. The incumbent will develop systems for managing each aspect of this lifecycle and drive progress with investigators, research teams and various stakeholders engaged in IITs from initiation to publication.
RESPONSIBILITIES
· Responsible for establishing an integrated IIT Program Office that provides protocol development, data management, startup & amendment related processes for IITs from initiation to closeout.
· Directly oversee a team comprising Protocol Writers, Project Managers, and EDC Design Leads, and project-manage the work of various specialists engaged in study startup (Regulatory, Financial, Clinic, Lab, etc.); remain accountable for projects end-to-end.
· Responsible for ensuring study protocol and other required minimum documentation are complete, vetted with all relevant stakeholders, and aligned prior to study entering startup.
o Oversee protocol writers and actively manage or coordinate with staff who are engaged in development of protocol and ancillary documents (manuals, patient facing documents) through an iterative development process until final signoff by Investigator.
o Facilitate financial, clinic feasibility completion and alignment with protocol documents prior to studies entering startup.
· Oversee the development and maintenance of guidelines, Standard Operating Procedures (SOPs), workflows, and templates to support related to protocol development and data capture & management activities for IITs.
o Maintain protocol templates for treatment trials, interventional non-treatment trials, and non-interventional studies; ensuring appropriate stakeholder review and communications prior to release.
o Oversee authoring and maintaining of data-related documents including, but not limited to: eCRFs, eCRF Completion Guidelines, and Data Management Plans.
· Identify and implement systems to support efficient and quality IIT protocol and database development and management.
· Develop and manage processes and systems to assess protocol design and data quality throughout study lifecycle.
· Recommend, draft, and implement institution-wide policy regarding IIT protocol development and data management requirements.
REQUIRED QUALIFICATIONS
· Bachelor’s degree required or equivalent experience.
· Minimum three years of staff management experience and five years of experience in clinical trial/protocol management.
· Demonstrated knowledge of clinical research operations and current regulations related to FDA, INDs, IDEs, Human Subjects, and Good Clinical Practice.
PREFERRED QUALIFICATIONS:
· Experience managing investigator-initiated trials protocol development including hands-on experience writing clinical research protocols.
· Knowledge of FDA regulations, GCP guidelines, and other applicable federal regulations.
· Knowledge of CTMS and EDC systems.
· Knowledge of EHR systems.
The annual base salary range for this position is from $139,464 to $232,419,
This position may be eligible for relocation assistance and/or a sign on bonus