Clinical Research Associate

Company Overview

RevBio, Inc. is at the forefront of medical device innovation, focusing on bone repair through its breakthrough regenerative bone adhesive, TETRANITE®. This product is currently being evaluated in seven clinical trials approved by the FDA and offers superior adhesion in wet environments, rapid mechanical support, and promotes bone regeneration. Engineered for applications in fields such as neurosurgery, orthopedics, and dentistry, TETRANITE® targets a $10 billion market with plans for commercialization by the third quarter of 2027. Its patented technology outperforms traditional bone fixation methods, aiming to enhance patient outcomes.

Role Overview

The Clinical Research Associate (CRA) will play an essential role in managing and executing clinical trials across various indications and regions including the United States, Europe, and the United Kingdom. This role involves collaborating with investigative sites, internal teams, and external partners to ensure that clinical studies comply with protocols, regulatory standards, Good Clinical Practice (GCP), and company objectives.

Key Responsibilities

• Develop a comprehensive understanding of RevBio’s TETRANITE® applications and clinical study requirements by liaising with internal experts and clinical specialists.
• Assist in the daily operational aspects of clinical trials, including site initiation, training, routine monitoring, and study closeout, ensuring compliance with protocols and regulatory frameworks.
• Educate clinical sites on protocols, investigational product usage, and instructions for use (IFU) under guidance from leadership.
• Gather and organize clinical data from study sites systematically.
• Support site visits, including surgical enrollment, to enhance adherence to study protocols and foster strong relationships with clinical teams.
• Track trial progress at sites and communicate updates, risks, and challenges to the company headquarters to maintain compliance and timelines.
• Ensure timely data entry, source documentation completion, query resolution, and data uploads via electronic data capture systems.
• Verify documentation to assist with payment approvals related to product delivery and data submissions.
• Help prepare and submit clinical trial documentation such as protocols, informed consent forms, regulatory submissions, and related amendments.
• Support ethics committee and Institutional Review Board (IRB) applications, modifications, and renewals.
• Maintain organized and compliant clinical site documentation per quality management standards.
• Promptly escalate protocol deviations, data discrepancies, and operational concerns to internal teams.
• Assist in managing adverse event reporting, documentation, and communication with clinical oversight committees.
• Participate in additional tasks that promote clinical study execution and support organizational operations.

Education and Experience Requirements

• Bachelor’s degree in fields such as Engineering, Biology, Physiology, Life Sciences, or related disciplines.
• Between 0 to 5 years of relevant experience in clinical research, site management, trial monitoring, or related roles in medical device or pharmaceutical sectors; international clinical research experience is advantageous.
• Proven experience supporting clinical trial site operations including training, monitoring, communication, and documentation management.
• Strong organizational skills with high attention to detail and accuracy.
• Ability to independently manage multiple tasks and meet deadlines.
• Effective verbal and written communication capabilities, suited for interaction with surgeons, clinical staff, and team members.
• Proficiency in MS Office (Word, Excel, PowerPoint), Smartsheet, Viedoc or equivalent electronic data capture systems, and project management tools.
• Experience with clinical trial documentation, data querying, and site follow-up preferred.
• Familiarity with scientific writing, abstract development, presentations, and grant proposals is a plus.

Specialized Skills and Knowledge

• Solid understanding of clinical trial operations, GCP guidelines, and regulatory requirements applicable to the US, European, and UK markets.
• Capability to operate effectively within multicultural and multidisciplinary teams.
• Strong interpersonal skills for building collaborative relationships with medical professionals and research staff.
• Skill in identifying and addressing site operational or compliance challenges.
• Experience with clinical site engagement, conference representation, and scientific communication considered beneficial.
• Self-driven with the ability to take initiative and support diverse clinical activities.
• Adaptable and entrepreneurial mindset to navigate the dynamic environment of a growing start-up.
• High professionalism and discretion in representing company interests.
• Willingness to travel extensively (50–75%) across the US, Europe, and UK as needed.
• Committed to supporting the company’s growth and achievement of clinical and business milestones.