What are the responsibilities and job description for the Regulatory Coordinator II - Central Reg Training and QC position at Fred Hutchinson Cancer Center?
Overview:
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 Coordinator II - Central Reg Training and QC is part of our central team providing regulatory support to Principal Investigators (PIs) and research study teams focused on mission-critical clinical trials programs. The role will be responsible for regulatory management of trials, which may cover submissions in the study startup phase through closeout. The incumbent will report to the Assistant Director of Regulatory Operations.
This is a remote position.
Responsibilities:
The annual base salary range for this position is from $77,976 to $102,211, 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 (12-22 days per year), paid sick leave (12-25 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 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 Human Resources at hrops@fredhutch.org or by calling 206-667-4700.
Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.
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 Coordinator II - Central Reg Training and QC is part of our central team providing regulatory support to Principal Investigators (PIs) and research study teams focused on mission-critical clinical trials programs. The role will be responsible for regulatory management of trials, which may cover submissions in the study startup phase through closeout. The incumbent will report to the Assistant Director of Regulatory Operations.
This is a remote position.
- Collaborates on Central Regulatory process development.
- Collaborates and supports the development of Central Regulatory templates and guidance.
- Tracks and Maintains documentation of Central Regulatory.
- Supports the development of regulatory training video walk-throughs.
- Collaborate on the development and updating of QC materials for the Central Regulatory department.
- Perform full and condensed quality control checks of regulatory documents for the Central Regulatory Team.
- Collects and maintains metrics on quality control checks.
- Support evaluation of reporting recommendations for non-compliance and unanticipated problems to IRB as applicable.
- Work professionally and proactively with central offices, research managers and other research collaborators in support of central regulatory quality and training.
- Serve as liaison for internal regulatory bodies (IRB, Clinical Research Support, Regulatory Affairs, etc.)
- Stay abreast of new impacts/areas of knowledge and regulatory changes and disseminate this knowledge to the study/operations team.
- Identify, develop and implement any necessary revisions to related policies and procedures.
MINIMUM QUALIFICATIONS:
- Bachelor's Degree or equivalent experience.
- 3 years working in clinical research environment (oncology preferred).
- Demonstrated knowledge of regulatory guidelines (IRB, IACUC, MUA, etc.), knowledge of FDA, GCP and NIH requirements, ability to interpret and synthesize regulations and guidelines.
- Ability to adapt and adjust priorities based on changing needs, strong written and verbal communication skills, problem solving skills and the ability to reach and reconcile data in reports.
- Ability to use discretion and maintain confidentiality.
- Strong organizational, document management and time management skills.
- Advanced knowledge of MS Word and Acrobat.
PREFERRED QUALIFICATIONS:
- Associate’s or Bachelor’s degree, Clinical Research Coordinator certification (CCRC) or Research Professionals certification (ACRP or SOCRA), prior experience working with NIH, FDA and OHRP regulations.
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.
The annual base salary range for this position is from $77,976 to $102,211, 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 (12-22 days per year), paid sick leave (12-25 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).
Salary : $77,976 - $102,211
