Fred Hutchinson Cancer Research Center Clinical Research Coordinator II-Pergam Group in Seattle, Washington
Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
The position will work directly with an Associate Member in the Infectious Disease Sciences Program in the Vaccine and Infectious Disease Division to provide support to the PI and research staff in the development, implementation and management of his diverse research portfolio, including research studies and clinical trials.
The Clinical Research Coordinator (CRC) will be responsible for providing support on all aspects of research study and clinical trial development and implementation. Primary responsibilities of the CRC will include assistance with the planning, coordination, implementation, and close-out (e.g. presentation of data, manuscript writing) of retrospective and prospective observational or investigator-initiated interventional studies. Additional responsibilities will include communicating with internal and external collaborators and supporting study personnel in the preparation of regulatory documentation and audits if applicable.
Under the supervision of the Principal Investigator, the CRC will manage a portfolio of complex research projects and will be required to perform their responsibilities with a high level of independence within the scope of study protocol(s) and institutional guidelines. The position will include interaction with patients, physicians, researchers, and other clinical providers and support staff within and outside of the Fred Hutch / Seattle Cancer Care Alliance (SCCA) / UW system including the SCCA Patient Care Services.
- Principal Investigator Support:
- Serve as designee of the PI to manage the daily research operations of assigned studies in accordance with regulatory, GCP guidelines and institutional policy. Develop, coordinate and manage research studies conducted by principal investigator including: develop study protocol, consent form, CRFs, and study procedures/SOPs; manage subject recruitment and enrollment; conduct of study intervention; and biospecimen collection and processing.
- Research Study Support:
Provides proactive regulatory consultation and support throughout the lifecycle of a studies and clinical trials
Provides representation and direct support to sponsor-investigators, clinical investigators, and staff
Makes detailed observations, analyzes and interprets data, and participate in the peer-reviewed manuscript process
Directs the development of templates and tools for study teams
Develops internal processes and standard operating procedures for reviewing research activities
Provides regulatory support as needed for clinical monitoring activities
Manage monitoring visits and quality control reviews by Sponsors or Investigators
- Protocol Implementation and Study Management:
Develop and maintain tools for study implementation
Ensure clinical procedures, lab tests and other protocol-specific activities are completed as outline in the protocols
Educate clinical teams, ancillary departments, and patients to ensure safe and accurate protocol implementation
Work with internal partners to obtain and submit budget and billing information
Ensure adherence to contracts and grants
Serve in lead role for data coordinator(s), clinical research coordinators, and other staff on PIs projects
Perform clinical research support as requested
Bachelor’s degree in scientific/medical field or equivalent experience/education
Minimum of three years post-master’s or five years post-bachelor’s experience in clinical study/trials coordination or related field
Strong scientific writing skills
Strong organization skills
Strong computer skills, including proficiency in the Office Suite, and experience working with databases
Superior communication skills, precise attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment. Ability to work collaboratively and build relationships across multiple organizations
Knowledge of medical terminology and statistics
Knowledge of federal regulations and guidelines that govern clinical research, including GCP and human subjects research
Able to assess risk in the conduct of clinical research
Master’s degree in healthcare related field preferred, particularly in the area of epidemiology
Clinical research related certification
Ability to perform basic statistical analyses
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