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 and largest 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.
This newly created position will coordinate all regulatory activity for active research programs in Hematologic Malignancies. Coordinates and monitors clinical trial regulatory activities in support of a significant number of complex interventional clinical protocols. Supports compliance with regulatory documentation requirements, primarily for the conduct and sponsorship of FDA-regulated studies of investigational new drugs.
The incumbent will:
1) provide support for data collection and reporting of clinical trial data in accordance with protocols subject to FDA oversight;
2) work independently with the FHCRC Institutional Review Office (IRO), Clinical Research Support Regulatory Affairs staff, and the Office of General Counsel in consultation on regulatory compliance issues; 3) use appropriate judgment in fulfilling regulatory compliance, quality assurance, and liaison activities;
4) work independently in documenting procedures, preparing reports, distributing communications, and coordinating special regulatory projects.
- Prepare, track, and maintain all correspondence and regulatory documentation required by Institutional Review Board (IRB), FDA, and other institutional and federal research oversight committees.
- Ensure compliance with ongoing reporting requirements including IRB and FDA initial protocol/IND submissions, annual reports, study amendment, safety reports, and unanticipated problem/noncompliance reports. Serves as primary liaison to regulatory bodies.
- Coordinate submission of new industry sponsored and investigator initiated IND applications to the FDA, and draft non-technical portions of IND applications. Support development, review, and maintenance of protocol-specific and IND-specific documents and procedures.
- Provide direct support with FDA interactions (teleconferences, meetings, email exchange, other communication); including documenting the interactions. Partner with Regulatory Affairs for any external audits and/or other situations as necessary.
- Assist in preparation and revision of protocols, consent forms, and other required documents for new and continuing studies.
- Maintain study regulatory binders. Facilitate and manage regulatory oversight of safety reporting.
- Support development, review, and maintenance of protocol-specific and IND-specific documents and procedures.
- Serve as the primary point of contact and resource to Investigators, study sponsors, and study team members for all general and protocol-specific regulatory requirements.
- Communicate with Investigators and study teams concerning status of regulatory approvals and changes in protocols, consent forms, or other study documents.
- Meet regularly with investigators and study teams concerning status of projects, priorities, upcoming data needs (e.g., upcoming grant renewals, publications, lectures).
- Serve as primary Liaison to regulatory bodies, such as Clinical Research Support, IRB, Regulatory Affairs, Fred Hutch internal monitoring program, other oversight committees.
- Maintain knowledge and understanding of all active clinical trials to ensure regulatory compliance.
- Initiate and/or actively participate in processes to improve regulatory compliance within the programs.
- Perform other responsibilities as assigned.
The ideal candidate will possess the following qualifications:
- BA/BS in a scientific field of study
- Minimum of 1 year post master's or 3 years post bachelor's project coordination experience in a research or academic setting
- 2-4 years of experience providing regulatory support for clinical trials in an academic clinical research, medical, or pharmaceutical/biotechnology industry setting; an advanced degree may substitute for a portion of the required experience
- Strong knowledge of FDA regulations and regulatory requirements; working knowledge of INDs, IDEs, Good Clinical Practice, and human subjects research
- MA/MS desired
- Prior experience as a Clinical Research Coordinator helpful
Key Skills and Abilities:
- Excellent verbal and written communication skills and knowledge of medical terminology required
- Ability to set and reevaluate priorities in response to ongoing duties and unanticipated requests
- Flexibility, ability to work independently, strong organizational skills, attention to detail, and advanced knowledge of MS office are required
If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2364521-2647-1021