29 days old

Clinical Research Regulatory Specialist

Dignity Health Research Institute - Arizona
Phoenix, Arizona 85013
  • Job Code
  • Job Type
  • Job Status
    Full Time

The Clinical Research Regulatory Specialist is responsible and accountable for ensuring inpatient and outpatient research protocols are coordinated through the regulatory process at study start-up and through the life of the study.  Job duties will include the review and preparation of site informed consent forms, collection and maintenance of regulatory documents, completion of Institutional Review Board (IRB) applications and modifications, tracking of IRB approvals, completion of continuing review reporting, and preparation and assistance with internal and sponsor monitoring visits.  Demonstrated knowledge and understanding of human research policies, regulations, procedures and standards according to FDA, ICH, GCP guidelines is required.  This position interacts with a variety of customers, both internal and external, requiring exceptional communication skills.  The ability to multi-task and remain organized in a high volume clinical trial setting is required. 


Minimum Required: 3-5 years related experience. Previous training in the area of regulatory submissions, research administration or other clinical trial experience required. Must be proficient in computer skills possessing a proactive strong organizational skill set.  Must have excellent verbal and written interpersonal skills to foster a team-spirited environment while always placing the patient or study subject, first.

Preferred experience: 5+ years experience

Minimum Education: Associate degree or equivalent combination of education and experience.

Preferred education: Bachelor's degree.


Posted: 2018-11-15 Expires: 2018-12-15

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Clinical Research Regulatory Specialist

Dignity Health Research Institute - Arizona
Phoenix, Arizona 85013

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