Regulatory Program Assistant II - Vaccine Trials Unit

Job ID
19783
Type
Regular Full-Time
Company
Fred Hutchinson Cancer Research Center
Location
US-WA-Seattle
Category
Clinical Research Support Services

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.


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 Program Assistant will be responsible for supporting projects related to the regulatory operations of the Vaccine Trials Unit (VTU). This position works under the supervision of the Regulatory Affairs Manager.

Responsibilities

  • Write and prepare IRB submissions including applications, renewals, amendments, consent forms, safety reports, study updates, etc.
  • Coordinate site registration activities with sponsors
  • Process and file regulatory documents at the clinical site within required timelines while ensuring all applicable guidelines are followed
  • Perform electronic data entry and ensure all applicable electronic systems, including the clinical trials management system, participant tracking system and electronic regulatory binder system are updated within required timelines
  • Implement informed consent processes onsite in accordance with Standard Operating Procedures
  • Collect and maintain cross-protocol VTU staff qualifications, licenses and training
  • Coordinate protocol-specific staff training and onboarding, ensuring completion of study-specific training, signature, and delegation logs. Continuously update materials in accordance with protocol opening, closing and staff turnover.
  • Assist in the coordination of project activities with external stakeholders
  • Assist in the development of research materials
  • Perform database queries and information searches for grant and regulatory annual reports
  • Provide clear and concise professional communication
  • Use judgment to interpret and apply federal and local regulations regarding clinical research
  • Perform other responsibilities as assigned

Qualifications

Minimum qualifications:

  • High school diploma or equivalent
  • Minimum one year of experience in a related field
  • Knowledge of regulations that govern clinical research with human subjects
  • Proficient in Microsoft Office, Adobe Acrobat Pro, and electronic data systems
  • Excellent verbal and written communication skills
  • Must be highly organized, exhibit strong attention to detail, and be able to manage multiple tasks and deadlines
  • Able to work collaboratively
  • Able to work with minimal supervision and within a team environment
  • Successful completion of Good Clinical Practice and Human Subjects Training will be required
  • Knowledge of and sensitivity to youth, racial, ethnic, cultural, and sexual diversity is essential


Preferred qualifications:

  • Bachelor’s degree
  • Previous experience in Human Subjects research or clinical trials

 

 

Application instructions:

Please submit a cover letter with your application to be considered for this position.

 


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

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