Regulatory Affairs Associate, Lead

Fred Hutchinson Cancer Research Center Seattle , WA 98113

Posted 1 week ago

Overview

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.

The Regulatory Affairs Associate or Regulatory Affairs Associate, Lead works with faculty and staff in the Cord Blood Transplant Program 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 incumbent is expected to work independently within a framework of established regulations and guidelines and demonstrate initiative and sound judgment in problem solving and providing regulatory guidance. Clinical research studies in the program include both investigator-initiated and industry-initiated protocols. The incumbent will prepare IRB documents and FDA correspondence, maintain regulatory files, and facilitate regulatory oversight of safety reporting. This position requires independent decision making in all aspects of the research study start up process as well as ongoing regulatory study maintenance. This position will be responsible for expeditious coordination of the regulatory submissions in the study start-up phase to meet sponsor and institutional timelines.

Responsibilities

  • In concert with IND Sponsors, prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits

  • Independently prepare IRB documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting

  • Coordinate the regulatory documents from each participating site for studies where the Fred Hutch Cord Blood Transplant Program serves as the Coordinating Center and Fred Hutch serves as the Central IRB of record. Coordinate protocol activation process and communicate activation communications allowing enrollment to start once regulatory documents (e.g. DSMB review) are in place.

  • Lead study start-up: prepare and submit all required regulatory documents for new study applications and successfully open new studies from inception to accrual

  • Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional, and federal regulations

  • Prepare, track and maintain all correspondence and regulatory documentation required by the IRB, FDA, IND Sponsors, and other institutional and federal oversight committees, including drafting and reviewing content as appropriate

  • Maintain study regulatory binders and electronic files in accordance with institutional and sponsor requirements

  • Perform internal audit and quality assurance checks on regulatory documents

  • With input from PIs and study team, draft consent forms and study documents

  • Process IND safety reports, maintain documentation of PI review and submit safety reports to the IRB as appropriate

  • Report noncompliances and unanticipated problems to the IRB as applicable

  • Stay abreast of new impacts/areas of knowledge and regulatory changes and disseminate this knowledge to the study team

  • With the Clinical Research Nurse, coordinate monitoring and auditing visits with Clinical Research Support (CRS), industry sponsors, and third-party auditors

  • Independently follow-up and resolve all issues related to regulatory concerns identified during monitoring visits

  • Maintain and update Investigator Brochure and regulatory forms per IND Sponsor and federal requirements

Qualifications

Required:

  • Bachelor's degree or equivalent experience. 3-5 years regulatory affairs experience with emphasis on INDs in a pharmaceutical, biotechnology, or academic clinical research setting

  • Previous regulatory experience related to multi-site clinical trials and deep understanding of coordinating center operations, strong knowledge of the regulatory requirements for single IRB review and must be able to nimbly respond to changes in the implementation of this new policy across many different institutions. Strong scientific and regulatory background to understand the study and anticipate other regulatory and institutional requirements that may apply at each site and affect the IRB process

  • Experience with IND submissions, FDA communications, and FDA audits

  • Experience designing regulatory management tools and interpreting federal regulations and guidelines for the study team

  • Experience with IRB procedures and practices

  • Effective written and verbal communication skills

  • Proficient with IT tools including databases

  • Proficient in word processing and previous experience with MS office programs (MS word, Access, Excel) required

  • High degree of organizational skills, effective time management, logical thinking, and close attention to detail; ability to remain calm, professional, diplomatic, and positive

  • Excellent interpersonal skills with the ability to build strong relationships across multiple organizations

  • Working knowledge of federal regulations including 21 CFR 50 and 56, and 45 CFR 46

  • Multitask without loss of efficiency or accuracy. This includes the ability to perform multiple duties received from multiple sources and/or situations requiring speed

  • Work and sustain attention with distractions and/or interruptions

  • Interact professionally with a variety of individuals, both internal and external, such as coworkers and teammates, customers, study participants and patients

  • Work effectively under stressful circumstances, such as tight deadlines

  • Maintain regular attendance and be punctual

  • Understand, remember and follow simple and/or detailed oral and written instructions

  • Complete assigned tasks with minimal or no supervision

  • Exercise independent judgment and make appropriate decisions

Preferred:

  • Greater than 5 years of regulatory experience in the conduct of interventional, treatment, and/or FDA-regulated, transplant study experience

  • Advanced degree (MPH or similar)

  • Advanced knowledge of FDA regulations, GCP guidelines, and other applicable federal regulations

  • Advanced knowledge of MS Word, Excel, and Acrobat

  • Professional Society Certification (SOCRA, RAC, etc)

  • Prior experience using RedCap database

  • Project management experience a plus

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 escmail@fredhutch.org or by calling 206-667-4700.


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Regulatory Affairs Associate, Lead

Fred Hutchinson Cancer Research Center