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 RevBio 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 RevBio, 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 RevBio’s clinical operations and external relationships. The successful candidate will be expected to develop a detailed understanding of RevBio’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:
Clinical Operations Management
- Interface with RevBio 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 RevBio 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 RevBio 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 RevBio’s Quality Management System and study requirements.
- Assist with site initiation, routine monitoring, site communication, and closeout activities as applicable.
- Escalate site issues, protocol deviations, data concerns, and operational challenges to appropriate internal team members in a timely manner.
- Support the investigation and follow-up of adverse events in collaboration with the clinical trial team, including the Principal Investigator, site personnel, and RevBio team members, ensuring accurate documentation and timely communication.
- Assist in preparing adverse event narratives, case summaries, and supporting materials for review by the Clinical Events Committee (CEC), Data Safety Monitoring Board (DSMB), and other study oversight groups, as applicable.
- Perform other duties as assigned to support clinical study execution and operational needs.
Site Relationship Management and Business Development
- Serve as RevBio’s primary day-to-day contact for assigned clinical sites, helping maintain productive and professional working relationships.
- Build and maintain strong relationships with surgeons, clinical staff, research coordinators, and hospital personnel to support successful study execution.
- Support identification and preliminary evaluation of potential new clinical sites and Principal Investigators in coordination with RevBio headquarters.
- Assist with site initiation, training, and ongoing engagement activities to promote site readiness, enrollment, and compliance.
- Support the development and organization of training materials, training logistics, and educational resources for new investigators and study personnel.
- Help identify opportunities for relationship building, investigator engagement, and potential future collaboration within the clinical and research communities.
External Engagement and Scientific Communication
- Represent RevBio professionally during site visits, investigator meetings, conferences, and external interactions as assigned.
- Support preparation of investigators and internal team members for scientific meetings and professional conference presentations.
- Assist in the preparation of clinical study summaries, slide materials, posters, abstracts, and other scientific communications.
- Contribute to manuscripts, conference abstracts, and grant support materials as requested.
- Maintain current knowledge of study data, product information, and clinical developments to support effective communication with external stakeholders.
Cross-Functional Collaboration
- Interface with project leaders, internal team members, and external vendors or contractors to support coordination of study activities and site needs.
- Work closely with RevBio’s engineering, regulatory, quality, and clinical teams to communicate site feedback, surgeon observations, and study execution needs.
- Support the identification and communication of practical solutions to site-level clinical and logistical challenges.
- Provide timely updates on site activity, study status, and operational needs to support internal alignment and decision-making.
- Perform other tasks as needed to support RevBio’s clinical, scientific, and strategic objectives.
Essential Education, Skills, Environment Education and Work Experience:
- Bachelor’s degree in Engineering, Biology, Physiology, Life Sciences, or a related field required.
- 0–5 years of experience in clinical research, site management, monitoring, or medical device/pharmaceutical trials. International experience preferred.
- Experience supporting the execution of clinical studies at the site level, including site communication, training, monitoring support, and study documentation.
- Demonstrated ability to work independently while managing multiple priorities and meeting deadlines.
- Strong organizational skills with meticulous attention to detail and accuracy.
- Effective oral and written communication skills, with the ability to interact professionally with surgeons, clinical staff, coordinators, and internal team members.
- Proficient in MS Office Suite (Word, Excel, PowerPoint), Smartsheet, Viedoc or similar EDC platforms, and project tracking tools.
- Experience supporting clinical trial documentation, data collection, query resolution, and site follow-up activities preferred.
- Exposure to manuscript support, abstract preparation, scientific presentations, and/or grant applications is preferred.
- Comfortable working on high-risk, early-stage technologies in a fast-paced, deadline-driven environment.
Specialized Knowledge and Skills:
- Working knowledge of clinical trial processes, Good Clinical Practice, and applicable regulatory requirements in relevant geographic regions, including the United States, Europe, and the United Kingdom.
- Ability to work effectively in multicultural, multidisciplinary environments.
- Strong interpersonal skills and ability to build productive working relationships with medical professionals, research coordinators, and site personnel.
- Ability to identify, communicate, and help resolve site-level operational and compliance issues.
- Familiarity with site interactions, conference participation, and scientific communication is preferred.
- Self-motivated and resourceful, with a willingness to take initiative and support a broad range of clinical activities.
- Entrepreneurial mindset and flexibility to adapt to changing priorities in a growing organization.
- High level of professionalism and discretion in representing company interests.
- Willingness and ability to travel extensively across the United States, Europe, and the United Kingdom, up to 50–75% as required.
- Commitment to doing what is needed to support a fast-growing start-up in achieving clinical and business milestones.
Flexible work from home options available.
