Research Regulatory Administrator

Thedacare • Appleton, WI

1d

About The Position

The Research Regulatory Administrator provides regulatory, monitoring, policy development, contractual and administrative oversight for all oncology and system related research. Provides direction for the operation of the Clinical Research Trials Office, including guiding the staff in addressing priorities and workload guidelines. Provides operational leadership for research regulatory compliance, contractual oversight, research billing and grants management, and maintenance of research associated operational policies and procedures. Serves as the ThedaCare Cancer Center and System accountable leader with the Institutional Review Board (IRB) of record for the study. Serves as a liaison between research staff, investigators, nurses, sponsor, internal/external regulatory oversight groups, government agencies (FDA, OHRP, HHS, etc.) and other organizations. Complies with program administration guidelines of federal and non-federal sponsors supporting research. Maintains awareness/knowledge of current and changing federally mandated regulations, policies and procedures related to research administration. Possess ability to interpret and apply sponsor, institutional, and departmental policies.

Requirements

• 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.

Nice To Haves

• 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

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

Benefits

• Lifestyle Engagement
• e.g. health coaches, relaxation rooms, health focused apps (Wonder, Ripple), mental health support
• Access & Affordability
• e.g. minimal or zero copays, team member cost sharing premiums, daycare

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees