Regulatory Affairs Associate/Regulatory Affairs Assc, Sr
Fred Hutchinson Cancer Research Center
Location: Seattle, Washington
Internal Number: 20839
Cures Start Here. AtFred 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 Hutchs 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 nations first cancer prevention research program, as well as the clinical coordinating center of the Womens 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 employeeswho bringdifferent and innovativeways of seeing the world and solving problems.Fred Hutch is in pursuit of becoming an antiracist organization.Weare committed to ensuring that all candidates hired share our commitment to diversity,antiracism, and inclusion.
The Regulatory Affairs Associate / Sr. Associate 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
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
Assist with the maintenance and management of 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.
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
Regulatory Affairs Associate, Sr.in addition to above responsibilities
Serve as regulatory liaison for interdepartmental and external agencies including, but not limited to Office for Human Research Protections (OHRP), Regulatory Affairs Branch (RAB), the Fred Hutchinson Cancer Research Centers Institutional Review Office and other research institutions site IRBs
In conjunction with IDS Regulatory Coordinator, facilitate and track trial protocols through all applicable review and approval processes including, but not limited to FDA, IRBs, RAB, and in-country agencies
Ensure that participating research sites have complied with all applicable regulatory requirements of the site registration process
Provide regulatory oversight on safety reporting for the IDS Program and related studies
Assist in compiling materials needed for investigational new drug (IND), submissions, IND safety reports, and annual reports as required
Design, develop and implement SOPs that ensures the IDS Program conducts its regulatory activities in accordance with FDA/ICH regulations and guidance documents.
Serve as an internal resource to address and resolve any questions or issues of a regulatory nature
Prepare and submit regulatory documents, as well as manage the regulatory archive.
Monitor, interpret and validate current and changing regulatory legislation and instructional polices, and ensure new regulations or changes to existing regulations are communicated throughout IDS to faculty and staff, and share potential impact these changes may have on ongoing protocols
Manage sites who utilize the FHCRC IRB as the IRB of Record
Provide expert review of non-lead IRB sites consent forms and other applicable regulatory documents
Coordinate with others, as appropriate, to resolve highly complex or extraordinary regulatory problems that may arise
Provide advice and counsel to the IDS faculty and staff and participating research institutions regarding regulatory requirements
Identify potential regulatory risks to the operational plans of the IDS Program and propose options to mitigate risks
REGULATORY AFFAIRS ASSOCIATE
Minimum Education/Work Experience:
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
SR. REGULATORY AFFAIRS ASSOCIATE
Minimum Education/Work Experience
Minimum BS in Life Sciences, advanced degree preferred
At least 5-7 years of experience working within the regulatory environment or related field with emphasis on INDs and IDEs in a pharmaceutical, biotechnology, or academic clinical research setting
Extensive and current working knowledge of FDA regulations, GCP, and International Conference on Harmonization guidelines
Honed knowledge of clinical trial safety issues
Excellent interpersonal skills and attention to detail
Professional Society Certification (RAC) and background in pharmaceutical regulatory affairs or law strongly desired
Previous clinical research regulatory coordinator experience working within Fred Hutchinson Cancer Research Center or University of Washingtons 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
Fred Hutch 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 provide proof of vaccination or initiate the accommodations process before their first day of employment.
A 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.
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 firstname.lastname@example.org or by calling 206-667-4700.
At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.