Regulatory Coordinator I

St. Luke's University Health Network•Allentown, PA

62d•Onsite

About The Position

The Regulatory Coordinator I is responsible for reviewing, preparing, and submitting clinical trial protocols to the IRB, ensuring compliance with all local, state, ICH/GCP Guidelines, and federal regulations. This role also provides administrative support to the regulatory team within the SLUHN Clinical Trials Office.

Requirements

Associate degree required; will accept High School degree with 1-2 years regulatory or administrative assistant/office management experience.
Familiar with medical terminology preferred.
Knowledge of Microsoft Office Programs: Word, Excel, Access, Outlook; Internet Functions.
Must possess strong organizational skills and strong attention to detail.
Must be able to multi-task efficiently.

Responsibilities

Demonstrates basic knowledge and practice of ICH/GP guidelines, FDA regulations and guidelines, HIPPA Regulations and Confidentiality Policy, and IRB policies related to clinical research.
Apply knowledge and skills to independently process IND Safety reports via Excel for all industry, Institutional, and NCTN (cooperative group) studies in an expeditious manner.
Track IRB submissions, approvals and expiration dates for all protocols, including initial, annual and amendment submissions to ensure timely turnaround times.
Ensure that submissions are accurate, properly formatted, complete, and in compliance with regulations and IRB policies and procedures.
Collaborates with the Regulatory team and other clinical trials staff to develop and maintain procedures for management of all regulatory aspects of the clinical trials.
Acquire the appropriate signatures for regulatory forms, and develop tracking tools for this process.
Prepare, maintain, and file all essential regulatory documentation required by sponsor or CRO (1572s, Financial Disclosure Forms, Delegation Logs, CVs and Medical Licenses, FCOI forms, SAEs and UAPs, training logs, etc.) within the study and regulatory binders.
Collect, maintain, and file all institutional clinical trials training requirements and tracking logs (NIH COI tutorial, CITI GCP, SLUHN COI disclosure statement, CVs, and Medical Licenses)
Collect, maintain, and file all institutional laboratory documents and tracking logs for Network (Lab Normal Reference Ranges, CAP, CLIA, Lab Permits, and Lab Director CV and Medical License)
Maintain NCI Investigator registration on a yearly basis as required by the NCI for NCTN studies.