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.
This team member:
1. Is responsible for administrative functions of regulatory submissions to internal and external Institutional Review Boards (IRB) and provides support to investigators and study team members. 2. Ensures proper compliance with institutional policies and procedures to ensure Dignity Health’s compliance with Federal, State and local laws/regulations. 3. Liaises between IRB, investigators, program managers, study team and industry sponsors. Acts as primary point of contact for industry sponsors relating to regulatory issues. 4. Maintains in-depth knowledge of frequently changing federal regulations and guidelines, and other literature related to human subject protections. 5. Ensures new protocols are submitted to the IRB within established time frames by compiling and coordinating appropriate paperwork. 6. Reviews incoming protocol amendments and revisions from sponsors, identifying necessary steps for processing, and consulting with Principal Investigator, Program Managers and other staff as needed. 7. Completes, maintains and updates study regulatory/legal documents per guidelines. 8. Maintains investigator CVs and medical licenses, staff CVs and licenses, training certificates, and lab licenses/certifications, ensuring all documents are current and on file. 9. Prepares for and assists with internal and external audits/inspections and monitoring visits. 10.Collaborates with investigators and program managers to complete FDA submissions. 11.Serves as a consultant to new investigators/staff interested in submitting projects to IRB. 12.Participates in the development and review of operating procedures for efficiency and effectiveness, recommends changes or improvements. 13.Performs related duties as required.
Minimumrequirements: 3-5 years related experience with associate degree or equivalent combination of education and experience.
Preferred: 5 years or more experience with bachelor's degree.
Additional Salary Information: Wages depend on education and experience.
Internal Number: 43310
About Dignity Health Research Institute - Arizona
At Dignity Health, we believe research is the cornerstone of every cure. We believe research provides opportunity to improve quality of life, an opportunity to improve health care for the next generation, an opportunity to find a cure. And we believe that connecting people and our patients with that opportunity is a basic tenet of humankindness.
Dignity Health offers more than 1,000 active clinical trials and research protocols to patients in California, Nevada, and Arizona.
Our investigators are among the nation’s most renowned doctors in their fields and are supported by dedicated staff.
The Dignity Health Research Institute team participates in multi-center, national and international clinical research trials, including many National Institutes of Health studies. The team also works in conjunction with highly-regarded academic institutions across the country. The ongoing growth both in trial volume and trial diversity represents a significant opportunity to patients and doctors, both within our care sites and in the communities we serve.
The mission of the Dignity Health Research Institute is to support continued innovation with the goal of finding new ways to provide t...imely and effective treatment to patients.
To learn more about the Dignity Health Research Institute ARIZONA region please call 866-367-4373 or DHRIAZ@DignityHealth.org