What are the responsibilities and job description for the Regulatory Coordinator position at Remington-Davis, Inc. Clinical Research?
Company Description
Remington-Davis, Inc. (RDI) is a trusted clinical research site based in Columbus, Ohio, with over 30 years of experience and more than 600 completed studies. Since 1992, RDI has partnered with major industry leaders, advancing medicine through its innovative approaches to clinical research. The company collaborates with board-certified physicians from over 20 specialties and maintains a strong connection to the diverse local community through an engaged participant database. RDI's dedicated 7,500-square-foot research facility provides modern amenities for patients and sponsors and supports on-site, hybrid, and decentralized clinical trial designs. Their commitment to fast startup timelines and a 97% retention rate ensures efficient trial execution and sponsor confidence.
Role Description
The Regulatory Coordinator will be responsible for managing the regulatory aspects of clinical research studies to ensure compliance with applicable guidelines and standards. This includes preparing, submitting, and maintaining regulatory documents, ensuring adherence to regulatory requirements, and supporting the coordination of regulatory submissions and approvals. Additional responsibilities include collaborating with internal teams, external sponsors, and regulatory agencies. This is a full-time position based on-site at the Columbus, OH facility.
Qualifications
- Experience in Regulatory Documentation management and preparation
- Understanding and adherence to Regulatory Compliance and Regulatory Requirements
- Proficiency in processing Regulatory Submissions and supporting Regulatory Affairs activities
- Strong organizational and time-management skills
- Ability to ensure accuracy under strict timelines and attention to detail
- Effective communication and collaboration skills with internal and external stakeholders
- Bachelor’s degree in a health science or related field; equivalent experience will also be considered
- Previous experience in clinical research or a regulatory role is highly preferred
- Familiarity with FDA guidelines and ICH-GCP regulations is an asset