Regulatory Coordinator

PNS Clinical Research (PNSCR) is the research division of Pacific Neuropsychiatric Specialists, a private practice spanning 8 locations and 60+ providers. PNSCR conducts phase II-IV psychiatry trials for indications including MDD, Schizophrenia, Alzheimer's Disease, and bipolar disorder.
Job Summary:
The Regulatory Coordinator will prepare and submit clinical research documentation to regulatory bodies and study sponsors involved in the pre-award and post-award process. Additionally, the Regulatory Coordinator will create and maintain site specific regulatory documents for awarded clinical trials and oversee the regulatory process on behalf of the site. 
Key Responsibilities:
• Serve as primary regulatory resource for providers, sponsors and study team, providing guidance on regulatory statuses and approvals.
• Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional, and federal regulations. Maintain study regulatory binders, ISFs and electronic files. 
• Prepare, track, and maintain all correspondence and regulatory documentation required by the IRB, FDA and other institutional and federal oversight committees. 
• Lead study start-up and close out: prepare and submit all required regulatory documents for new study applications; successfully open new studies from inception to activation; conduct study close out.
• Prepare materials for monitoring visits; serve as primary regulatory point of contact during visits. Independently follow-up and resolve all issues related to regulatory concerns identified during monitoring visits. 
• Prepare and submit modifications/amendments and continuing reviews for ongoing study maintenance. 
• Process safety reports; maintain documentation of PI review and submit/escalate safety reports as appropriate. 
• Report non-compliance and unanticipated problems to IRB as applicable. Perform internal audit and quality assurance checks on regulatory documents. 
• Stay current on new impacts/areas of knowledge and regulatory changes and spread this knowledge to the study/operations team. 
• Identify quality and performance improvement opportunities to support efficient workflows.
• Maintain strict patient confidentiality according to HIPAA regulations and follow guidance according to applicable law and research practices using Good Clinical Practice (GCP) guidelines.
• Identify noncompliance events; collect and analyze data and information related to the noncompliance events to determine if reporting to institutional and regulatory oversight bodies is required; determine the root cause of the events; and prepare reports and corrective and preventive action plans (CAPAs).
• Write and update clear and accurate informed consent forms (ICF) and HIPAA documents.
• Assist with study source creation and QC based on protocol requirements

Qualifications:
• Bachelor’s Degree in a health-related discipline (i.e. pharmacology, nursing, biology, etc.), or equivalent experience required
• Minimum one year of clinical research regulatory experience 
• Experience using central IRB
• Ability to interpret and apply local, state, and federal regulatory requirements
• Knowledge of FDA and GCP guidelines