Regulatory Coordinator II

 

The Regulatory Coordinator II will provide and manage support for comprehensive startup in the Cancer Consortium. The incumbent will work closely with CRS managers, startup team members, internal and external study teams, central offices, clinic partners, faculty members and research collaborators to ensure regulatory requirements are met.

 

The role will be a resource to CRS Central Startup Team members relative to central startup standard practices, generation and submission of regulatory documents and consents in support of larger CRS strategic goals initiatives.

 

The Regulatory Coordinator II will be responsible for expeditious coordination of the regulatory submissions in the study startup phase to support key metrics reported to institutional leadership. This position requires specific understanding of the research process for industry-sponsored and investigator-initiated clinical trials, advanced institutional knowledge of startup requirements, and dependencies, site specific clinic implementation processes and requirements, regulatory requirements, financial requirements and resources required to conduct clinical research.

• Manage startup timeline, ensuring that all regulatory requirements are executed in parallel with fnancial, clinic and contractual milestones accurately and expeditiously. Engage stakeholders throughout the study startup lifecycle to ensure adherence to timeline goals.
• Be a resource for investigator-initiated trials to ensure continuity with industry-sponsored trial startup standards, institutional goals, best practices, and standards in support of larger CRS strategic initiatives to increase quality and compliance.     
• Work closely with Startup Regulatory Operations Manager to ensure investigator-initiated trial startup processes are coordinated, transparent, efficient and support timeline metric goals; help determine and improve operational process standards based on feedback and data from internal and external partners.
• Manage required internal and external submissions including but are not limited to: Institutional Review Board (central or local), Institutional Biosafety Committee(s), Human Subjects Division, Institutional Review Office, Radiation Safety Committee, Scientific Review Committee, etc.
• Create informed consent forms in accordance with GCP and FDA guidelines, ensuring all appropriate elements of informed consent; 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.
• Ensure regulatory documentation is accurate and compliant by working proactively with central offices, clinic partners, faculty members and research collaborators.
• Create and manage 1572s, financial disclosures, laboratory accreditations, laboratory reference ranges, CVs, medical licensures, delegation of authority logs, and required training documentation on behalf of study teams to ensure continuity with best practices.
• Serve as a subject matter expert in central startup intake, clinical trial regulatory startup operations and resource allocation.
• Collaborate with pharmaceutical sponsors, institutional sponsors, and study teams to integrate and implement regulatory oversight and review.
• Manage source documentation and records practices throughout the startup process for continuity with CRS standards and best practices in support of IRB, FDA and other institutional and federal oversight.
• Support communications and trackers to maximize transparency and efficiency from intake to handoff.
• Report startup progress to Investigators, study teams, internal and external stakeholders to ensure transparency throughout the startup process in support of larger strategic initiatives.
• Support CRS initiatives that will maximize efficiencies in startup and intake.
• Other duties as assigned.

MINIMUM QUALIFICATIONS:

• Bachelor’s Degree or equivalent years of experience.
• 3 years' experience working in clinical research environment.
• Experience using central and local IRBs.
• FDA, GCP, and NIH requirements relating to research involving human subjects.
• Demonstrated ability to write informed consent documents.
• Demonstrated ability to work as part of an integrated team.
• Demonstrated ability to deliver a high standard of work.
• Ability to interpret and apply local, state, and federal requirements.
• 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.

PREFERRED QUALIFICATIONS:

• 3 years’ experience starting and managing clinical trials, preferably oncology trials both industry-sponsored and investigator-initiated.
• Clinical research related certification.
• Demonstrated ability to deliver outcomes in fast paced environments.
• Demonstrated ability to work as an effective member of an interdisciplinary team.
• Demonstrated skills in critical thinking and problem solving.
• Ability to process complex documents and extract key information.
• Working with multi-disciplinary teams.
• Forecasting and meeting deadlines.
• Communicating with all levels of a research organization.
• Familiarity with project management tools and techniques.
• Familiarity with CTMS and systems to support workflow & metrics.
• Proficiency in use of Excel.
• Strong attention to detail and ability to work according to CRS central office standards and best practices.
• Excellent interpersonal skills and ability to build positive and professional working relationships with internal and external stakeholders. 
• Effectively able to communicate and demonstrate accountability in a remote setting.

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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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The annual base salary range for this position is from $68,162 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). 

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.