Clinical Research Regulatory Specialist

2 weeks ago

Seattle, Washington, United States Fred Hutchinson Cancer Center (Fred Hutch) Full time

Regulatory Coordinator II

Job Overview
Fred Hutchinson Cancer Center is a leading independent nonprofit organization dedicated to advancing adult cancer treatment and pioneering research in cancer and infectious diseases. Located in Seattle, Fred Hutch is recognized as the sole National Cancer Institute-designated cancer center in Washington.

With a distinguished history in areas such as bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccine development, Fred Hutch is esteemed globally for its contributions to cancer, infectious disease, and biomedical research. The center operates multiple clinical care sites offering a range of services including medical oncology, infusion, radiation, and proton therapy, alongside partnerships with hospitals across several states. Our integrated research and clinical teams are committed to discovering innovative cures for some of the most challenging diseases, striving to make life beyond cancer a reality.

Position Summary
The Regulatory Coordinator II plays a crucial role within our central team, providing essential regulatory support to Principal Investigators (PIs) and research teams engaged in critical clinical trial programs. This position is responsible for overseeing the regulatory management of trials, encompassing the entire process from study initiation to closeout. The individual will report directly to the Assistant Director of Regulatory Operations.


Key Responsibilities
  • Prepare, monitor, and maintain all regulatory correspondence and documentation required by the IRB, FDA, and other oversight committees, including drafting and reviewing content as necessary.
  • Submit all regulatory documents to the IRB and other governing bodies to ensure compliance with Good Clinical Practice (GCP), institutional, and federal regulations.
  • Maintain comprehensive study regulatory binders and files.
  • Conduct internal audits and quality assurance checks on regulatory documents.
  • Collaborate with PIs to draft initial informed consent forms for clinical research trials.
  • Lead the study start-up process by preparing and submitting all necessary regulatory documents for new study applications, ensuring successful initiation and accrual of new studies.
  • Prepare and present materials for monitoring visits, acting as the primary contact during these evaluations.
  • Independently address and resolve all regulatory issues identified during monitoring visits.
  • Prepare and submit modifications, amendments, and continuing renewals for ongoing study maintenance.
  • Oversee study close-out procedures.
  • Process IND external safety reports, maintaining documentation of PI review and submitting/escalating safety reports as appropriate.
  • Report any non-compliance and unanticipated problems to the IRB as necessary.
  • Serve as the primary regulatory resource for physicians, sponsors, and study teams, providing guidance on regulatory statuses, approvals, and patient consent instructions.
  • Act as a liaison for internal regulatory bodies, including the IRB, Clinical Research Support, and Regulatory Affairs.
  • Stay informed about new regulatory developments and disseminate relevant knowledge to the study and operations teams.
  • Identify, develop, and implement necessary revisions to related policies and procedures.

Qualifications

Required:

  • Bachelor's Degree in a health-related field (e.g., pharmacology, nursing, biology) or equivalent experience.
  • A minimum of 3 years of relevant experience in oncology quality assurance, regulatory affairs, or clinical research/study coordination.
  • ACRP or SoCRA certification (or a professional certification in a related field such as Regulatory, QA, or Clinical Research) is preferred.
  • Proven ability to draft informed consent documents.
  • Experience with both central and local IRBs.
  • Ability to interpret and apply local, state, and federal regulations.
  • Demonstrated capability to work collaboratively within an integrated team.
  • Commitment to delivering high-quality work.
  • Familiarity with FDA, GCP, and NIH requirements regarding research involving human subjects.
  • Strong organizational and document management skills.
  • Effective verbal and written communication skills.
  • Robust analytical and problem-solving abilities.
  • Excellent time management skills.
  • Advanced proficiency in MS Word and Acrobat.

All finalists are requested to provide a statement detailing their commitment and contributions toward enhancing diversity, equity, inclusion, and anti-racism in their careers or through their work at Fred Hutch.

Fred Hutchinson Cancer Center is dedicated to fostering a diverse and inclusive workplace. We are an Equal Employment Opportunity (EEO) and Affirmative Action employer, encouraging individuals from diverse backgrounds to apply.

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