Clinical Research Associate

@ Activ

Job Overview

Activ Surgical is seeking a highly motivated and detail-oriented Clinical Research Associate to support the planning, execution, and monitoring of clinical studies for advanced surgical visualization technologies. This role involves managing pre-clinical trials, first-in-human trials, Phase I and II studies, and ongoing clinical investigations across domestic and international sites.

Key Responsibilities

Clinical Trial Management: Support planning, initiation, execution, and close-out of various clinical trials including pre-clinical, first-in-human, Phase I, and Phase II studies. Coordinate trial activities domestically and internationally while ensuring compliance with protocols, SOPs, GCP, ICH, and local regulatory requirements. Serve as the primary liaison with clinical sites, investigators, and study staff, ensuring accurate collection, verification, and reporting of data.

Site Monitoring & Compliance: Conduct site selection, qualification, initiation, routine monitoring, and close-out visits. Monitor adherence to study protocols, regulatory requirements, and patient safety standards. Identify and resolve protocol deviations and maintain up-to-date Trial Master File (TMF) and essential study documentation.

Regulatory & Quality Oversight: Ensure all clinical trials are executed under FDA regulations, ISO standards, ICH/GCP guidelines, and Activ Surgical’s quality systems. Contribute to regulatory submissions, safety reporting, and audit preparations. Assist with the preparation of key documents including the Investigator’s Brochure and Clinical Study Reports.

Cross-Functional Collaboration: Partner with R&D, Regulatory, Quality, and Commercial teams to align trial execution with corporate strategy. Provide clinical input to the development of innovative surgical visualization technologies such as Laser Speckle Contrast Imaging (LSCI), Multispectral Imaging (MSI), and AI-based applications. Support KOL engagement and training related to clinical trials.

Qualifications

Bachelor’s or Master’s degree in Life Sciences, Nursing, Biomedical Engineering, or a related field. 2-5+ years of CRA experience in medical device or biotech clinical trials, with preference for surgical device or imaging experience. Expertise in first-in-human studies, Phase I and II trials, FDA, ICH, GCP, ISO 14155, and global regulatory frameworks. Proficient in electronic data capture systems and common office software, with a willingness to travel 15-25% domestically and internationally.

Personal Attributes & Benefits

Team-oriented, adaptable, and customer/patient-focused with strong communication and organizational skills. Benefits include Health Care Plan (Medical, Dental & Vision), Retirement Plan (401k, IRA), Life Insurance, Paid Time Off, Family Leave, Short & Long Term Disability, Training & Development, Work From Home, and Wellness Resources.

Key skills/competency

Clinical Trials, FDA, GCP, ICH, Regulatory Compliance, Site Monitoring, Data Verification, Surgical Visualization, Medical Devices, International Coordination