Regions Hospital Regulatory and Business Operations Specialist in St Paul, Minnesota
Regulatory and Business Operations Specialist
- Job ID:
St Paul, MN
RH - Regions Hospital & Clinics
- Position Type:
- Anticipated Work Schedule:
- Hrs/Pay Period:
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POSITION SUMMARY STATEMENT:
This position will support the regulatory and business operations functions of the Critical Care Research Center (CCRC) within HealthPartners Institute. The CCRC leads and supports hospital-based research at Regions and Methodist hospitals. Responsibilities will include complete maintenance of regulatory documents for investigator initiated, industry sponsored, and federally funded clinical trials. Other responsibilities include preparation and submission to internal Institutional Review Board (IRB) and external regulatory entities as required. This position serves as the lead coordinator of the business operations of the Critical Care Research Center and maintains all electronic platforms, including the Clinical Trial Management System, EPIC and other financial systems. This position also assists with the coordination of the CCRC’s internship program, providing a valuable and inclusive learning experience for aspiring research and medical staff.
Education: Bachelor’s degree preferred
Experience: A minimum of 2 years’ experience in clinical research.
Strong preference for candidates with:
Experience supporting the regulatory aspect of clinical research studies, including experience with ensuring compliance with preparation and maintenance of required regulatory materials
Previous experience with preparation and submission of IRB applications, annual IRB reviews and IRB amendments.
Previous experience with site initiation, site close-out visits and audits with industry-sponsored projects.
Previous experience with electronic patient care records and electronic clinical databases preferred
Prefer previous experience with Clinical Trial Management Systems
Previous experience with regulatory requirements for clinical research
Previous experience with clinical research budgets and budget negotiations
Minimum 2 years of experience as a clinical research coordinator
Licensure/ Registration/ Certification:
Valid driver’s license
Certification related to clinical research preferred, but not required (CCRC, CRA, etc.)
Knowledge, Skills and Abilities:
Proficiency in Microsoft Office Suite required: Word, Excel, Outlook, PowerPoint
Ability to prioritize and excellent written communication skills required
Ability to establish and maintain effective relationships with patient care providers, regulatory bodies, and HPI and departmental staff
Active problem solving, flexibility, self-motivation and self-learning, with a desire to work with diverse workforce
Must be able to work independently with a high attention to detail
Demonstrated knowledge of and ability to maintain required site regulatory documentation for clinical research studies (Delegation of Authority log, 1572, etc.)
Demonstrated knowledge of IRB application development, submission, and study maintenance.
Knowledge of industry sponsors and clinical trial site regulatory requirements
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.