Regulatory Affairs Associate - Infectious Disease Sciences Program
Regulatory Affairs Associate - Infectious Disease Sciences Program
Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, 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 Program Operations Director in the IDS Program.
Regulatory Affairs Associate 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.).
Write and prepare regulatory submissions including applications, renewals, amendments, consent forms, safety reports, study updates, etc. in accordance with required timelines.
Prepare and coordinate site registration materials/submissions and assist with communications with sponsors and contract research organizations (CROs).
Assist in the development of project/study policies and procedures. Administer policies and procedures according to protocol, regulatory, and lab safety policies.
In partnership with the PI, prepare and track all clinical activity documents including IRB/IBC/site registration approvals, safety reports, deviations, laboratory certifications, staff training & licenses, monitoring notices and reports, inspections & compliance, etc.
Create, maintain, and audit systems for tracking and implementing regulated activities at the clinical locations.
Assure the proper management, retention, and version control of all applicable regulatory documentation including master files and amendments.
Assist in the coordination of project activities to ensure they follow timelines and meet deadlines.
Assist in the development of research materials.
Perform information searches related to studies and projects.
Use judgment to interpret and apply federal and local regulations regarding clinical research.
Perform other tasks as assigned.
The level of Regulatory Affairs Associate or Regulatory Affairs Associate Lead will be determined based on the qualifications below.
3-5 years of experience working in regulatory affairs or related field with emphasis on INDs and IDEs in a pharmaceutical, biotechnology, or academic clinical research setting.
Preparing and reviewing IND applications.
Communicating with FDA and preparing for FDA inspections.
Assessing risk in the conduct of clinical research.
Designing tools for the regulatory management of clinical trials.
Interpreting federal regulations and guidelines.
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.
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 on-line/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.
Master’s degree in regulatory affairs preferred—for Lead Regulatory Affairs Associate level.
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through work at Fred Hutch is requested of all finalists.
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 email@example.com or by calling 206-667-4700.