Regulatory Affairs Coordinator

Posted: 11/12/2019 7:41:17 PM

Job Snapshot

Location: Seattle, WA, US
Posting ID: 7004773

Job Summary

Our client is currently looking to bring on a Federal Regulatory Affairs Coordinator in Seattle, WA.

The Regulatory Affairs Coordinator prepares, facilitates, coordinates, and submits documentation required by federal, state and local regulations and institutional requirements relating to the conduct of research.

Must Haves:
  • 2 years as Regulatory Affairs coordinator OR 1-2yrs as Regulatory Coordinator in Oncology
  • Oncology
  • Study start-up, study maintenance, study close-out
  • Informed consent

  • Team player
  • Exposure to pharma/sponsor-initiated studies

In this position you will:
  • Prepare all submissions to the Internal Review Board (IRB) to assure the protection of human subjects in research; FDA-required submissions which may include investigator 1572 forms, investigational new drug applications, device submissions such as Emergency use, HDE, Safety Reports, and other documents that may be required by a regulatory agency or the institution.
  • Provide on-the-job training, set priorities and schedule workflow required to support project objectives.
  • Serve as liaison between sponsors, researchers, staff, and study coordinators.
  • Coordinate and negotiate with commercial study sponsors with regards to consent form language.

Please reach out if this is a position you would like to be considered for!

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.


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About CareerCircle

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Contact Information

Name: Jack Taylor
Phone: (425) 893-6058