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IRB Regulatory Coordinator II

Fred Hutchinson Cancer Center

Job Description

 

Overview:

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. These values are grounded in and expressed through the principles of diversity, equity and inclusion. 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. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.
 

The incumbent works with faculty and staff in the Infectious Disease Sciences (IDS) Program in the Vaccine and Infectious Disease Division to ensure all regulatory compliance measures are followed for clinical trials by coordinating regulatory submissions and monitoring as well as assisting with the resolution of compliance issues. The position is expected to work independently within a framework of established regulations and guidelines, and demonstrate initiative and sound judgment in problem solving, providing regulatory guidance and developing policies and procedures. Responsible for preparing IRB documents and FDA correspondence, maintaining regulatory files, and facilitates regulatory oversight for all related studies. This position has significant interactions with the PI(s), other team members, internal departments and external organizations and agencies. The position reports to the Regulatory Affairs Supervisor in the IDS Program. This is a part time (0.7 FTE) position.
 

This role will have the opportunity to work partially at our campus and remotely.

Responsibilities:

Regulatory Coordinator II responsibilities:

  • Prepare, track and maintain all correspondence and regulatory documentation required by the IRB, FDA, sponsors, 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 electronic files g. SharePoint, OneDrive, OnCore.
  • Perform internal audit and quality assurance checks on regulatory documents.
  • With input from PIs, study team, draft initial clinical research informed consent forms and study documents.
  • 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; may 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 in a timely manner.
  • Conduct study close-out. Be responsible for archiving regulatory documents/records, ensuring that all files are prepared for off-site storage in accordance with FDA, other applicable regulatory guidelines and program SOP.
  • Process IND external safety reports, maintain documentation of PI review and submit safety reports to the IRB as appropriate.
  • Report non-compliance and unanticipated problems to the IRB as applicable.
  • Serve as primary regulatory resource for PIs, sponsors, a 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. Work with IRB team and IDS leadership to develop standard operating procedures (SOPs).
  • Identify, develop and implement any necessary revisions to related policies and procedures.
  • Work with fiscal team/PI/study team regarding funding proposals, annual progress reports.
  • Coordinate and manage the regulatory documents from each participating site for studies where IDS serves as the IRB of record (coordinating center). Also track sites’ annual continuing reviews and alert sites to upcoming expirations to prevent lapses from occurring.
  • Manage the regulatory tracking and archive systems (e.g. SharePoint, Clinical Trials Management System, shared network drive, etc.).
  • Perform other tasks as assigned.

Qualifications:

Minimum Qualification

  • High school diploma or equivalent
  • A minimum two years of regulatory, human research protection or related experience in a research environment.
  • Previous work experience preparing and/or reviewing study start-up documents, including IRB documentation and research protocols.
  • Knowledge of FDA, ICH/GCP guidelines.
  • Strong verbal and written communication skills working across multiple disciplinary teams.
  • Ability to adapt and adjust priorities based on changing needs, and the ability to troubleshoot and problem-solving skill.
  • Excellent time management skills and meet deadlines
  • Working knowledge of Microsoft Suite, SharePoint, Adobe Suite, Clinical Trials Management System.
  • Ability to use discretion and maintain confidentiality.

Preferred Qualifications:

  • Associate's or Bachelor’s degree
  • Previous clinical research regulatory coordinator experience working within Fred Hutchinson Cancer Research Center or University of Washington’s institutional regulatory system
  • Previous experience working with online/web-based platforms for clinical trial management systems
  • Certified IRB Professional (CIP) certification preferred
  • Knowledge of regulations and guidelines that govern clinical research, including but not limited to FDA regulations and Good Clinical Practice
Fred Hutchinson Cancer Center has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations. As a condition of employment, newly hired employees must, prior to their first day of employment:
Provide proof of being fully vaccinated against COVID-19 ; OR
Initiate the accommodations process to request a religious or medical accommodation (medical accommodations require a healthcare provider’s certification).
 
statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

 

The hourly pay range for this position is from $31.49 to $46.32 and pay offered will be based on experience and qualifications.
 

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), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months). Paid time off is prorated for part-time positions.

Our Commitment to Diversity: We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.

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