Clinical Research Associate

Job Description:

The Clinical Research Associate will support the execution and oversight of clinical studies across multiple indications and geographic regions, including the United States, Europe, and the United Kingdom. This individual will work closely with investigative sites, internal team members, and external partners to help ensure that clinical trials are conducted in accordance with study protocols, applicable regulations, Good Clinical Practice, and corporate objectives.

The Clinical Research Associate will play a key role in site management and study execution, including supporting site initiation, training, routine monitoring, and close-out activities as applicable. They will assist in ensuring that sites are properly trained on study protocols, investigational use requirements, and study procedures, and will help monitor adherence to protocol, informed consent requirements, data collection expectations, and reporting obligations.

The Clinical Research Associate will also support the review of study data, identification and follow-up of discrepancies or compliance issues, and timely communication of site needs, risks, and study progress to Rev Bio headquarters.

This role requires strong attention to detail, organization, and communication skills, as well as the ability to build productive working relationships with surgeons, clinical staff, and research coordinators. The Clinical Research Associate will help maintain effective communication between clinical sites and Rev Bio, support site performance and enrollment efforts, assist with essential study documentation, and contribute to inspection readiness and overall study quality.

In addition to supporting study execution, the Clinical Research Associate may assist with conference attendance, investigator engagement, clinical material preparation, and other activities that strengthen Rev Bio’s clinical operations and external relationships. The successful candidate will be expected to develop a detailed understanding of Rev Bio’s products, clinical studies, and therapeutic applications, and to serve as a reliable operational partner in the advancement of the company’s clinical programs.

Essential Duties and Responsibilities:

• Interface with Rev Bio team members and clinical subject matter experts to develop working knowledge of the clinical applications, study requirements, and product use considerations for Tetranite in each indication under investigation.
• Support the day-to-day execution of clinical studies across multiple indications and geographic regions in accordance with protocol, Good Clinical Practice, applicable regulations, and company procedures.
• Train and support clinical sites on study protocols, investigational product use, and applicable Instructions for Use (IFU) under the direction of Rev Bio leadership.
• Collect, collate, organize, and track scientific and clinical study data from participating sites.
• Attend surgical enrollment visits and site interactions, as needed, to support protocol adherence, product use compliance, and strong working relationships with investigators and site staff.
• Monitor site-level trial progress and communicate status updates, risks, and issues to Rev Bio headquarters to support compliance with protocol, timelines, and regulatory requirements.
• Follow up with investigators and site personnel to support timely completion of EDC entries, source documentation needs, query resolution, and required data uploads.
• Review site activity and supporting documentation to assist with payment approvals and verification of corresponding product delivery and data submission.
• Assist in the preparation and submission of clinical trial protocols, informed consent documents, study materials, and regulatory documentation required to initiate and maintain clinical studies, including amendments and supplements.
• Assist in the preparation and submission of ethics committee and IRB applications, including supplements, renewals, and amendments as needed.
• Maintain organized, accurate, and complete clinical site files and documentation packages in accordance with Rev Bio’s Quality Management…