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 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 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 II will be responsible for supporting projects related to the regulatory operations of the Clinical Scholars (CS) research group of the Clinical Research Division (CRD). This entry-level position works under the supervision of the Regulatory Affairs Manager.
Process and file regulatory documents 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 and electronic regulatory binder system, are updated within required timelines
Collect and send staff qualifications, licenses, and training to institutional office for upload to the institutions electronic storage platform
Coordinate protocol-specific staff training and onboarding, ensuring completion of study-specific training, signatures, and delegation logs
Continuously update materials in accordance with protocol opening, protocol closure, and staff turnover
Draft, distribute, and finalize Site Initiation Visit (SIV) minutes and attendance log
Track and maintain correspondence and regulatory documentation required by the IRB, FDA, IND Sponsors, and other institutional and federal oversight committees
Track follow up letter receipt for monitoring, communicate with research teams to ensure responses to listed issues, and submit to institutional office according to established timelines
Assist in the coordination of regulatory compliance activities with various stakeholders
Perform internal audit and quality assurance reviews of regulatory documents, as directed by senior staff
Provide timely, clear, and professional communication
Perform other responsibilities as assigned
Associate degree or minimum two years of experience in a health-care related field
Proficient in Microsoft Office, Adobe Acrobat Pro, and electronic data systems
Well-developed effective verbal and written communication skills
Must be very organized, exhibit strong attention to detail, and be able to manage multiple tasks and deadlines
Able to work with minimal supervision and collaboratively 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 research or clinical trials
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 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.