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 Regulatory Coordinator works in coordination with other Study Startup team members to perform comprehensive study startup support. The Regulatory Coordinator will be responsible for expeditious coordination of the regulatory submissions in the study startup phase to support key metrics reported to institutional leadership. At any given time, there will be 5 to 15 trials actively in startup. The incumbent will report to the Start-Up Operations Manager. Responsibilities - Prepare and submit required internal and external submissions over the course of study startup and site activation. These include but are not limited to the submissions to an Institutional Review Board (central or local), the Institutional Biosafety Committee, the Radiation Safety Committee, and the Scientific Review Committee.
- Write informed consent forms in accordance with GCP and FDA guidelines, ensuring all appropriate elements of informed consent. Must be able to explain complicated research protocol requirements to research participants using easily understood language.
- Integrate information from multiple sources and use specialized knowledge of institutional, state, and federal requirements to ensure compliance with those entities
- Understand the timing and implications of other team members startup requirements to ensure accurate and effectively timed submissions
- Liaise with investigators, industry sponsors, and study teams to ensure accuracy of documentation
- Create, manage, and supply supportive documents such as 1572s, financial disclosures, laboratory accreditations, laboratory reference ranges, CVs, medical licensures, delegation of authority logs, and required training documentation
- Create tools to support organized startup efforts to be used within the team, Clinical Research Support, and the Cancer Consortium
Qualifications Experience and Abilities - 3+ years working in clinical research environment (oncology preferred)
- Demonstrated ability to write informed consent documents
- Experience using central and local IRBs
- Ability to interpret and apply local, state, and federal requirements
- Demonstrated ability to work as part of an integrated team
- Demonstrated ability to deliver a high standard of work
Knowledge and Skills - Bachelors Degree
- Clinical research related certification preferred
- FDA, GCP, and NIH requirements relating to research involving human subjects
- Strong organizational and document management skills
- Strong and effective verbal and written communication skills
- Strong analytical and problem-solving skills
- Excellent time management skills
- Advanced knowledge of MS Word and Acrobat
A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through 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. |
