Regulatory Coordinator, Clinical Research & IRB Compliance

Pnsoc; Orange (CA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Paid time off

Training & development

Vision insurance

401(k) matching

Dental insurance

Job summary

PNS Clinical Research (PNSCR) in California seeks a Regulatory Coordinator to manage regulatory submissions and maintain study documentation for phase II–IV psychiatry trials across multiple sites.

You will serve as a regulatory expert for providers and sponsors, prepare IRB submissions, write consent forms, ensure HIPAA compliance, and drive study startup and maintenance with accuracy and timeliness.

Qualifications

• Bachelor’s Degree in a health-related discipline or equivalent experience
• 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

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

Skills

Regulatory experience in clinicals

IRB coordination

FDA and GCP knowledge

Regulatory documentation

Education

Bachelor’s Degree in health-related discipline

Job description

PNS Clinical Research (PNSCR) in California seeks a Regulatory Coordinator to manage regulatory submissions and maintain study documentation for phase II–IV psychiatry trials across multiple sites.

You will serve as a regulatory expert for providers and sponsors, prepare IRB submissions, write consent forms, ensure HIPAA compliance, and drive study startup and maintenance with accuracy and timeliness.