Regulatory Coordinator I/II - Lab Based Studies

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.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

The Immunology and Vaccine Development (IVD) Program is a large and diverse program within the Vaccine & Infectious Disease Division (VIDD). The program supports the research of more than 20 Principal Investigators (PIs).

The Regulatory Coordinator ensures all regulatory compliance measures are followed for investigator-initiated and lab-based studies by coordinating regulatory submissions and assisting with compliance monitoring and the resolution of compliance issues.

This is a hybrid position that does require employee be onsite 3 days a week.

The Regulatory Coordinator works independently within a framework of established regulations and guidelines. Demonstrates initiative and sound judgment in problem solving, providing regulatory guidance and in developing policies and procedures. May have significant interaction with the PI(s), other team members, internal departments and external organizations and agencies.

JOB DUTIES

Regulatory Coordinator I:

Prepare, track and maintain all correspondence and regulatory documentation required by the IRB, FDA and other institutional and federal oversight committees, including drafting and reviewing content as appropriate
• Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional and federal regulations
• Assures the proper management, retention, and version control of all applicable regulatory documentation including study regulatory binders and files
• With input from PI(s), draft research protocol documents and clinical research informed consent forms
• Coordinate activities to ensure they follow timelines and meet deadlines
• Lead study start-up: prepare and submit all required regulatory documents for new study applications; successfully open new studies from inception to accrual
• May prepare and present materials for monitoring visits and serve as primary point of contact during visits
• Independently follow-up and resolve issues related to regulatory concerns identified during regulatory review and monitoring visits
• Prepare and submit modifications/amendments and continuing renewals for ongoing study maintenance
• Conduct study close-out
• Process IND external safety reports; maintain documentation of PI review and submit/escalate safety reports as appropriate
• Report non-compliance and unanticipated problems to IRB as applicable
• Serve as liaison for internal regulatory bodies (IRB, IBC, IACUC, Regulatory Affairs, etc.)
• Stay abreast of new impacts/areas of knowledge and regulatory changes and disseminate this knowledge to the study/operations team
• Uses judgment to interpret and apply federal and local regulations regarding research

Regulatory Coordinator II:

• May perform internal audit and quality assurance checks on regulatory documents
• May serve as primary regulatory resource for physicians, sponsors and study team, providing guidance on regulatory statuses, approvals and instructions regarding research participant consent
• Identify, develop and implement any necessary revisions to related policies and procedures

MINIMUM QUALIFICATIONS:

Regulatory Coordinator I:

• High school diploma or equivalent.
• Minimum of one year of regulatory, human research protection, or related experience in a research environment.
• Demonstrated knowledge of regulatory guidelines (IRB, IACUC, MUA, etc.).
• Knowledge of FDA, GCP and NIH requirements.

Regulatory Coordinator II:

• In addition to minimum qualifications for Regulatory Coordinator I, at least two years of regulatory, human research protection or related experience in a research environment.
• Ability to interpret and synthesize regulations and guidelines.
• Ability to adapt and adjust priorities based on changing needs, strong written and verbal communication skills, problem solving skills and the ability to reach and reconcile data in reports.
• Ability to use discretion and maintain confidentiality.
• Proficiency with MS Office suite.

PREFERRED QUALIFICATIONS:

• Associate or Bachelor's degree
• Two to three years of work experience in clinical research with emphasis on IRBs, Ethics Committee and Human Subjects review in pharmaceutical, biotechnology, or academic research settings
• Experience with regulatory affairs in an academic research environment
• Clinical Research Coordinator certification (CCRC) or Research Professionals certification (ACRP or SOCRA)
• Prior experience working with NIH, FDA and OHRP regulations.

Regulatory Coordinator I: The hourly pay range for this position is from $28.36 to $40.37 and pay offered will be based on experience and qualifications.

Regulatory Coordinator II: The hourly pay range for this position is from $33.42 to $50.12 and pay offered will be based on experience and qualifications.

This position is not eligible for H-1B sponsorship at this time.

Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks).