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 with minimal side effects. 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.
The Regulatory Affairs Associate is responsible for preparing and managing documentation for Institution-Sponsored INDs. The position will liaise with investigator and study teams, perform regulatory review of study documents, maintain regulatory files, facilitate regulatory oversight of safety reporting, and draft FDA correspondence. This position will report directly to the CRS Quality Program Manager.
- Drafts and reviews document content (protocols, ICFs, Investigator Brochures, IND annual reports, FDA correspondence, etc), maintains documentation of the review, and communicates any changes needed to investigators.
- Distributes regulatory documents to investigators.
- Liaises with investigator and study teams to ensure Sponsor oversight and reporting requirements are met.
- Facilitates regulatory oversight of safety reporting.
- Coordinates and provides operational support for the assembly and distribution of FDA submissions and tracks dates of submissions and responses.
- Maintains Sponsor regulatory files including IND, Investigator, Manufacturing, and Trial Master Files.
- Extracts data from study databases for scheduled and ad hoc reports for ongoing review of safety data, and IND annual reports.
Experience and Abilities
- 3+ years working in regulatory affairs with emphasis on INDs in a pharmaceutical, biotechnology, or academic clinical research setting. Additional experience as a Clinical Research Coordinator a plus.
- Reviewing IRB documentation & research protocols
- Writing technical documents
- Preparing and reviewing IND applications
- Communicating with FDA and preparing for FDA audits
Knowledge and Skills
- Bachelor's Degree
- Clinical research related certification preferred
- Knowledge of US FDA regulations and guidelines that govern clinical research (GCP/ICH and IRB)
- Excellent written & verbal communication skills including the ability to communicate clearly, succinctly and effectively over the phone and in writing.
- Ability to work independently and pro-actively with excellent time management skills
- Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive.
- Ability to work collaboratively and build relationships across a large organization
- Detail-oriented with the ability to handle multiple ongoing projects/tasks
- Advanced knowledge of MS Word, Excel, & Acrobat
** Please include cover letter with your application
We are a VEVRAA Federal Contractor.
If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2350876-2647-021