Regulatory Coordinator

Pacific Neuropsychiatric Specialists•Orange, CA

22h•$60,000 - $80,000

About The Position

Responsible for the preparation, organization and implementation of regulatory research documents such as pre-study activities, initiation, execution, and reporting on the various status of research tasks in accordance with FDA guidelines, ICH GCP and SOPs. Prepares, submits, and maintains clinical research regulatory documentation in accordance with FDA regulations, ICH-GCP guidelines, and sponsor requirements. Supports clinical trial start-up, ongoing study activities, and close-out processes, ensuring documentation is accurate, complete, and timely.

Requirements

Bachelor’s Degree in a health-related discipline (i.e. pharmacology, nursing, biology, etc.), or equivalent experience required
1+ year of clinical research regulatory experience required
Experience using central IRB, familiarity with local, state, and federal regulatory requirements and knowledge of FDA and GCP guidelines
Demonstrated prioritization and organizational skills to efficiently and effectively, providing accurate information in a timely manner
Proficient in eRegulatory systems (CRIO, Florence, etc.), IRB portals, vendor portals and sponsor portals (strongly preferred)

Responsibilities

Serve as primary regulatory resource for providers, sponsors and study team, providing guidance on regulatory statuses and approvals.
Submit all regulatory documents including modifications, advertisement, continuing review, close out, etc. to the IRB and other governing bodies to maintain study compliance with GCP, institutional, and federal regulations.
Maintain site regulatory binders under the electronic regulatory platform CRIO, sponsor specific regulatory platforms, and any provided paper ISFs.
Collects, prepares, and submits documentation to various sponsors/CROs during study start-up, including: Submission documents/approval, Protocol amendments with respective signature pages, Informed consent documents, FDA form 1572, Lab normal result documents, financial disclosure forms, Delegation of authority logs, Licenses, Reports
Maintain all regulatory logs including temperature logs, master subject logs, screening and enrollment logs, informed consent logs, monitoring visit logs, training logs, etc.
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.
Write and update clear and accurate informed consent forms (ICF) and HIPAA documents.
Prepares appropriate reports for submission as required to the IRB including Serious Adverse Events (SAE's), protocol deviations and other required reports
Process safety reports; maintain documentation of PI review and submit/escalate safety reports as appropriate.
Identify and report non-compliance and unanticipated problems to IRB as applicable; 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).
Maintain strict patient confidentiality according to HIPAA regulations and follow guidance according to applicable law and research practices using Good Clinical Practice (GCP) guidelines.
Create study source documents based on protocol requirements within the electronic source platform, CRIO.
Make required updates to source based on protocol and eCRF amendments.
Maintain strict patient confidentiality according to HIPAA regulations and follow guidance according to applicable law and research practices using Good Clinical Practice (GCP) guidelines.