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
Numbers & Facts
Location
Orange, CA
Job Type
Full-time
Skills
Alzheimer'sunmatched
Biologyunmatched
Clinical Practices/Protocolsunmatched
Clinical Researchunmatched
Clinical Study Publicationsunmatched
Clinical Trialunmatched
Conduct Studiesunmatched
Corrective Actionunmatched
Data Analysisunmatched
Data Collectionunmatched
Dental Insuranceunmatched
Diseaseunmatched
Federal Laws and Regulationsunmatched
GCP (Good Clinical Practices)unmatched
HIPAA (Health Insurance Portability and Accountability Act)unmatched