- Manage study team post approval impact following regulatory committee approvals to include electronically filing of approvals in CTMS, distribution of updated study documents and management of required training documentation.
- Management of Investigator Site files in electronic Florence database including DOA and coordination of ongoing monitor activities.
- Coordinate distribution of third-party safety reports for Investigator review.
- Provide administrative support for queries and required follow-up from the CRS office.
- Support the Regulatory A?airs Associates in ongoing continuous improvement activities.
- Liaise with Investigators and Clinical Operations study team to ensure accuracy of documentation.
- Other duties as assigned.
- Bachelor's degree or equivalent combination of education and experience.
- Minimum 1 year of prior experience in a clinical research setting.
- Knowledge of regulations and guidelines for conducting clinical research. Previous experience with regulatory document preparation and prior experience working with E-Binders (e.g. Florence).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.
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Regulatory Affairs Coordinator - Seattle, United States - Fred Hutchinson Cancer Research Center
Description
OverviewFred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases.
With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers.
Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states.
Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.
At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. These values are grounded in and expressed through the principles of diversity, equity and inclusion.Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter.
Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.The Regulatory Affairs Coordinator will work with faculty and staff within the IIRC, along with regulatory bodies and other departments at Fred Hutch to ensure all clinical trials are supported for regulatory compliance.
Responsible for ensuring all clinical trials and other research projects are compliant with federal and institutional policies.The role assists with the preparation, submission, and maintenance of clinical trials regulatory data which requires compliance with several sources of complex regulations, policies, and procedures for how clinical trials are conducted.
At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.
This hybrid position and requires candidates be onsite at least one day a week.ResponsibilitiesPRIMARY/ESSENTIAL DUTIES:
QualificationsMINIMUM QUALIFICATIONS:
PREFERRED QUALIFICATIONS:
The hourly pay range for this position is from $26.99 to $38.43 and pay offered will be based on experience and qualifications.
Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security.Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation days per year), paid sick leave days per year), paid holidays (13 days per year), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).Our Commitment to DiversityWe 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 Human Resources at or by calling #J-18808-Ljbffr
Regulatory Affairs Coordinator professionals in Seattle
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Nicole Zhang
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Tryniti Smith
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