Coordinator - Medical Records

Louisiana State University

1d•Onsite

About The Position

Pennington Biomedical Research Center, a world-renowned academic research institute of Louisiana State University, is seeking a Medical Records Coordinator in the Clinical Trials Unit. The Medical Records Coordinator supports clinical research operations by coordinating the retrieval, organization, maintenance, and secure management of participant medical records and research documentation for clinical trials. The position ensures study records are accurate, complete, and maintained in accordance with Good Clinical Practice (GCP), HIPAA, FDA regulations, sponsor requirements, and institutional policies. This role collaborates closely with investigators, clinical research coordinators, regulatory staff, and healthcare providers to facilitate efficient study conduct, monitoring visits, audits, and regulatory inspections while safeguarding participant confidentiality and maintaining data quality. The ideal candidate enjoys working in a collaborative, fast-paced research environment, has a strong understanding of regulatory requirements, and takes pride in maintaining organized, audit-ready records that support high-quality clinical research. This role is well suited for someone who thrives on precision, values confidentiality, and is committed to advancing scientific discovery through exceptional documentation and data management practices.

Requirements

Associate's degree in Health Information Management, Health Sciences, Clinical Research, Healthcare Administration, Medical Office Administration, or a related field.
Two (2) years of experience managing medical records, clinical documentation, or research records in a healthcare, academic medical center, or clinical research environment.
Working knowledge of Good Clinical Practice (GCP), HIPAA, FDA regulations, and Institutional Review Board (IRB) requirements.
Demonstrated ability to manage multiple studies and competing priorities while maintaining exceptional attention to detail, organization, and accuracy.
Strong written and verbal communication skills with the ability to collaborate effectively.
Proficiency with Microsoft Office Suite.
Other duties as assigned.

Nice To Haves

The ideal candidate enjoys working in a collaborative, fast-paced research environment, has a strong understanding of regulatory requirements, and takes pride in maintaining organized, audit-ready records that support high-quality clinical research.
This role is well suited for someone who thrives on precision, values confidentiality, and is committed to advancing scientific discovery through exceptional documentation and data management practices.

Responsibilities

Coordinate the collection, organization, maintenance, and secure storage of medical records and source documentation for multiple clinical research studies, ensuring records are accurate, complete, and audit-ready throughout the study lifecycle.
Manage essential clinical trial documentation, including informed consent forms, medical records, laboratory and diagnostic results, treatment documentation, protocol deviations, adverse event reports, protocol amendments, study correspondence, and other required regulatory records.
Maintain Trial Master Files (TMFs) and other study documentation in accordance with Good Clinical Practice (GCP), FDA regulations, HIPAA, Institutional Review Board (IRB) requirements, sponsor expectations, and institutional policies.
Enter, validate, and maintain study information within electronic health records (EHRs), electronic data capture (EDC) systems, clinical trial management systems (CTMS), and other research databases, ensuring data accuracy, completeness, and timely documentation.
Collaborate with principal investigators, clinical research coordinators, sponsors, monitors, and other research professionals to obtain, reconcile, and maintain study documentation that supports clinical trial operations.
Prepare and maintain documentation for sponsor monitoring visits, quality assurance reviews, audits, and regulatory inspections by ensuring study records are complete, organized, and readily accessible.
Identify and resolve documentation discrepancies while maintaining the confidentiality, integrity, and security of participant information and supporting the successful execution of clinical research studies.
Other duties as assigned.