Job Details

Title: Regulatory Coordinator I
Company: Fred Hutchinson Cancer Center
Location: Seattle, WA

 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 Regulatory Coordinator is responsible for preparing and processing submission documentation for clinical trials and investigator-initiated clinical research. The position will prepare FDA, IRB and IBC documents and other study-related tools for the start-up and management of clinical research, maintain regulatory files, and facilitate onsite processing at the Vaccine Trials Unit clinical location(s).

Responsibilities
- Provides regulatory support to investigators and staff throughout the lifecycle of a clinical trial or clinical research protocol
- Writes, prepares and submits complex IRB/IBC submissions including applications, renewals, amendments, consent forms, safety reports, etc. in accordance with required timelines
- Prepares and coordinates site registration (RSC) materials/submissions and assist with communications with sponsors
- Develops internal processes, tools/templates, and standard operating procedures for the clinical research team
- Assists in the coordination of project activities to ensure they follow timelines and meet deadlines
- Assists in the development of research materials
- Performs information searches related to studies and projects
- Provides clear and concise professional communication
- Uses judgment to interpret and apply federal and local regulations regarding clinical research


 
Qualifications

REQUIRED
- High school diploma or equivalent
- Minimum of one year of regulatory, human research protection or related experience in a research environment
- Knowledge of US FDA regulations and guidelines that govern clinical research (GCP/ICH and IRB)
- Ability to work collaboratively and build relationships across a large organization
- Excellent written and verbal communication skills including the ability to communicate clearly, succinctly and effectively over the phone and in writing
- Excellent time management skills
- Advanced knowledge of MS Word and Acrobat
- Skilled in the use of clinical trials and electronic document management systems

PREFERRED
- Associate’s or Bachelor’s degree in a related field
- 2-3 years working in clinical research with emphasis on IRBs, Ethics Committee and Human Subjects review for a pharmaceutical, biotechnology, or academic clinical research setting
- Regulatory and/or Clinical research-related certification (RAPS, ACRP, SOCRA)

The hourly pay range for this position is from $26.20 to $37.31 and pay offered will be based on experience and qualifications.  

To apply for this position or to learn more, please click "Apply Online" below.

SOCRA Exp: 2/12/2023