TheRegulatory Coordinator II is part of our central team providing regulatory support to Principal Investigators (PIs) and research study teams focused on mission-critical clinical trials programs. The role will be responsible for regulatory management of trials, which may cover submissions in the study startup phase through closeout. The incumbent will report to the Assistant Director of Regulatory Operations.

This position will support trials within our Industry and IIT portfolio.

This is a remote role

• 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.
• Maintain study regulatory binders and files.
• Perform internal audit and quality assurance checks on regulatory documents.
• With input from PI(s), draft initial clinical research trial informed consent forms
• Lead study start-up: prepare and submit all required regulatory documents for new study applications; successfully open new studies from inception to accrual.
• Prepare and present materials for monitoring visits; serve as primary point of contact during visits.
• Independently follow-up and resolve all issues related to regulatory concerns identified during 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 primary regulatory resource for physicians, sponsors and study team, providing guidance on regulatory statuses, approvals and instructions regarding patient consent.
• Serve as liaison for internal regulatory bodies (IRB, Clinical Research Support, Regulatory Affairs, etc.).
• Stay abreast of new impacts/areas of knowledge and regulatory changes and disseminate this knowledge to the study/operations team.
• Identify, develop and implement any necessary revisions to related policies and procedures.

MINIMUM QUALIFICATIONS:

• High school diploma or equivalent.
• Minimum of two years 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,
• 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:

• Associates or Bachelors degree, Clinical Research Coordinator certification (CCRC) or Research Professionals certification (ACRP or SOCRA).
• Experience working with NIH, FDA and OHRP regulations.
• Demonstrated ability to write informed consent documents.
• Ability to interpret and apply local, state, and federal requirements.
• Demonstrated ability to work as part of an integrated team.
• Demonstrated ability to deliver a high standard of work.
• Strong organizational and document management skills.
• Strong and effective verbal and written communication skills.
• Strong analytical and problem-solving skills.
• Excellent time management skills.
• Advanced knowledge of MS Word and Acrobat.

The annual base salary range for this position is from $80,172 to $104,250, and pay offered will be based on experience and qualifications.Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.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).