ThedaCare · 2 weeks ago
Research Regulatory Administrator
ThedaCare Regional Cancer Center
Full-time
Onsite
Mid, Senior Level
3+ years expThedaCare is a health care system dedicated to providing outstanding care and reinventing health care. The Research Regulatory Administrator is responsible for providing regulatory oversight for oncology and system-related research, ensuring compliance with federal and non-federal regulations, and managing the Clinical Research Trials Office.
Health CareHospitalMedical
Responsibilities
Serves as primary accountable leader for all regulatory and contractual research activity on behalf of ThedaCare Cancer Center and other system associated research
Supervises institutional pharmaceutical/industry partnership compliance, as it relates to reviewing proposals to guide negotiation, administration and monitoring of contracts, grants, and subaward/subcontract issuance and execution and response to external audits
Partners with Research Medical Director to act as liaison with grant partners and non-ThedaCare practice partners (i.e., surgical/radiation oncology/ radiology groups and academic partners)
Partners with Research Medical Director to act as liaison with all pharmaceutical and industry grant partners at the Cancer Center and Systemwide
Cultivates and nurtures strategic partnerships with pharmaceutical industry sponsors to drive business and research expansion. Develops professional relationships with key sponsor representatives
Primary accountable leader for contract initiation, renewals, and maintenance in ThedaCare UCM contract management application
Reviews and guides others in the review of financial and administrative management requirements of research contract and grant proposals, awards, and transactions to ensure compliance with institutional and sponsor policies
Provides analytical and financial support in proposal processing, contract and grant administration, and budget development, including pre-award proposal initiatives, management of funds post-award, and closeout activities for federal, state, local, and private sponsors
Leads activities associated with forecasting, planning, and managing of research portfolio by coordinating, identifying, and developing and/or presenting proposals, contracts, and other agreements
Manages large systemwide regulatory projects or processes and analyzes problems/issues of diverse scope and determines solutions (research billing; contractual and legal addendum development and redlining)
Supports thorough understanding of research administration guidelines of Federal and non-Federal sponsors supporting research and educational activities. Seeks information to maintain current knowledge on compliance regulations in all areas of research administration
Develops framework to ensure compliance with all protocol requirements
Develops multidisciplinary plan for opening new studies
Ensures timely submission of required documents to the sponsor and the IRB of record for the study
Maintains complete and accurate collection of research management administration documents for all research studies
Assists in support of audits as directed or required and ensures that documentation is audit ready
Provides administrative and operational support to Principal Investigators proposing for funding through a variety of agencies
Acts as the subject matter expert for new policy creation to comply with research requirements and in the interpretation of policy for others. Generates and approves purchase requisitions for payment and travel reimbursements
Ensures that research-mandated educational requirements for institution/research studies are completed on a regular basis
Prepares/manages agenda and minutes for research and related meetings
Qualification
Required
Bachelor's degree from an accredited college or university in a related field- required
Minimum of three years of experience and knowledge directly related to IRB operations and human research protections including ethics, clinical trial performance, or in an academic IRB- required
Must have familiarity with federal regulations governing human subjects research and conflict of interest
Preferred
Previous human subjects research compliance, contractual management and/or research administration experience- highly preferred
Previous oncology research and/or legal/contract experience- highly preferred
One or more of the following preferred and/or able to obtain within 6 months of hire: CCRC (Certified Clinical Research Coordinator), CIP (Certified IRB Professional), RAC (Regulatory Affairs Certification), CRA (Certified Research Administrator)
Master of Regulatory Affairs (MRA) or Masters in Regulatory Science degree highly preferred
Benefits
Lifestyle Engagement
Access & Affordability
Company
ThedaCare
For nearly 115 years, ThedaCare® has been improving the health and well-being of the communities it serves in northeast and central Wisconsin.
5001-10000 employees
Funding
Current Stage
Late StageLeadership Team
Mark Thompson
Chief Operating Officer/Chief Financial Officer
Recent News
2025-01-17
Milwaukee Business Journal
2024-12-20
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