Regions Hospital Regulatory Specialist .6D in St Paul, Minnesota
Regulatory Specialist .6D
- Job ID:
Critical Care Research
St Paul, MN
RH - Regions Hospital & Clinics
- Position Type:
- Anticipated Work Schedule:
M, W, F 8:00am-4:00pm
- Hrs/Pay Period:
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Position Summary:The Regulatory Specialist will support the regulatory and administrative aspects of the Critical Care Research Center (CCRC) at Regions Hospital. 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. Additional responsibilities include administrative assistance to the CCRC Clinical Research Manager, Director, and other staff as needed in support of general research and office activities.
- A minimum of 2 years administrative experience managing multiple projects and tasks, preferably in a medical or research related field.
Licensure/ Registration/Certification: Valid driver’s license
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.
Education: Bachelor’s degree preferred
Experience: Strong preference for candidates with:
Experience supporting the regulatory aspect of clinical research studies, including experience with preparation of various required materials and IRB submissions
Previous experience with electronic patient care records and electronic clinical databases preferred
Previous experience with Clinical Trial Management Systems
Previous experience with regulatory requirements for clinical research
Knowledge of industry sponsors and clinical trial site regulatory requirements preferred
Licensure/ Registration/Certification: Certification related to clinical research preferred but not required (CCRC, CRA, etc.)
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.