Regulatory Coordinator

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

Benefits

• Health insurance
• Paid time off
• Training & development
• Vision insurance
• 401(k) matching
• Dental insurance

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