Minnnesota Bioscience Jobs

Regulatory Specialist .6D

• Job ID:

57458

• Department:

Critical Care Research

• City:

St Paul, MN

• Location:

RH - Regions Hospital & Clinics

• Position Type:

Part-Time

• Anticipated Work Schedule:

M, W, F 8:00am-4:00pm

• Shift:

Day

• Hrs/Pay Period:

48

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Job Description:

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.

MINIMUM QUALIFICATIONS:

Experience:

• 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.

PREFERRED QUALIFICATIONS:

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.)

Additional Information:

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.