Regulatory Coordinator

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

• 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
  
  

• Bachelors 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

Pacific Neuropsychiatric Specialists specializes in high quality mental health care for patients of all ages offering advanced diagnosis and treatment for a wide range of psychiatric conditions including anxiety depression ADHD trauma and other complex mental health conditions.

PNS was founded on a simple conviction: every person deserves access to compassionate expert psychiatric care. Our roots trace back over 30 years to groundbreaking psychiatric research and since 2006 that same commitment has grown PNS into one of Southern Californias largest outpatient psychiatric groups.

In 2024 ATP Clinical Research became part of PNS and Dr. Gustavo Alva joined as Medical Director Clinical Research making PNS one of the largest community based psychiatric research programs in the country.

Today were Southern Californias trusted name in high quality mental health care and were growing: 60 full-time providers 200 clinical trials and 8 locations across the region.

Whether youre providing direct patient care supporting groundbreaking research or helping run one of our clinics youll be part of a team that treats children teenagers and adults facing anxiety depression PTSD bipolar disorder schizophrenia postpartum depression dementia and more.

Come grow with us. Were looking for people who want their work to matter.