What are the responsibilities and job description for the Senior Research Regulatory Specialist-PTNE, NHORA Research Operations, Days position at Norton Healthcare?
Responsibilities
The responsibilities include oversight of the research regulatory team workload distribution, development of institutional regulatory workflows, serve as consistent point of contact for the regulatory team for routine issues, participate on institutional committees and attend meetings on behalf of the Director of Research Compliance and Regulatory Affairs. Role is responsible for quality assurance, IRB submissions, and timeliness of reporting. This individual will oversee correspondence to the Norton-approved Institutional Review Boards, and ensure compliance with the internal Norton Healthcare Office of Research Administration (NHORA) requirements, Norton Healthcare policies, Good Clinical practice (GCP) for all phases of clinical trials, and local, state and federal regulations. This includes gathering all documentation for the submission of new protocols, amendments to protocols, and continuing annual review reports. Also, this position is responsible the maintenance of all federal and locally required regulatory documentation for every research study performed by a Norton investigator, and oversees the work distribution for this area. Candidate is responsible for representing NHORA to internal and external research professionals (e.g. Sponsors, Monitors, and Clinical Investigators) and regulators. Up to 10% local and national travel may be required.
Qualifications
Required:
- Five years in a clinical research field
- Bachelor Degree
Desired:
- Master Degree
- Certified Clinical Research Associate OR Certified Clinical Research Coordinator OR Certified Clinical Research Professional OR One of: CCRA or CCRC or CCRP