Regulatory Program Assistant II - Vaccine Trials Unit
Please visit our careers page to learn more and apply online: https://careers-fhcrc.icims.com/jobs/19783/regulatory-program-assistant-ii---vaccine-trials-unit/job
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.
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
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
Previous experience in Human Subjects research or clinical trials
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.