Job Description

Position Overview

Activ Surgical is seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to support the planning, execution, and monitoring of clinical studies for our advanced surgical visualization technologies. The CRA will play a critical role in pre-clinical trials, first-in-human trials, Phase I and Phase II studies, and ongoing clinical investigations across domestic and international sites. This position requires strong knowledge of FDA guidelines, Good Clinical Practice (GCP), and International Council for Harmonisation (ICH) regulations, with a proven ability to operate in fast-paced environments involving novel technologies.

Key Responsibilities

Clinical Trial Management

• Support planning, initiation, execution, and close-out of pre-clinical, first-in-human, Phase I, and Phase II clinical trials.
• Coordinate domestic and international trial activities, ensuring compliance with protocol, SOPs, GCP, ICH, and local regulatory requirements.
• Serve as primary liaison with clinical sites, investigators, and study staff.
• Ensure accurate collection, verification, and reporting of clinical trial 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, document, and resolve protocol deviations, ensuring corrective actions are implemented.
• Maintain up-to-date Trial Master File (TMF) and essential study documentation.

Regulatory & Quality Oversight

• Ensure clinical trials are executed under FDA regulations, ISO standards, ICH/GCP guidelines, and Activ Surgical's quality system.
• Contribute to regulatory submissions, safety reporting, and preparation for FDA, EMA, or other agency audits/inspections.
• Assist with preparation of Investigator's Brochure, Clinical Study Reports, publications and presentations.

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 novel surgical visualization technologies including Laser Speckle Contrast Imaging (LSCI), Multispectral Imaging (MSI), and AI-based applications.
• Support KOL engagement and training activities related to clinical trials.

Qualifications

• Bachelor's or Master's degree in Life Sciences, Nursing, Biomedical Engineering, or related field.
• 2-5+ years CRA experience in medical device or biotech clinical trials; surgical device or imaging experience preferred.
• Demonstrated expertise in first-in-human studies, Phase I and II trials, and novel technology evaluation.
• Strong working knowledge of FDA, ICH, GCP, ISO 14155, and global regulatory frameworks.
• Experience with domestic and international site management and multi-country trial coordination.
• Excellent communication, organizational, and problem-solving skills.
• Proficiency in electronic data capture systems and common office software.
• Willingness to travel (15-25% domestic and international).

Personal Attributes:

Teamwork-oriented with the ability to collaborate across functions and geographies

Operates with a sense of urgency in fast-paced, high-growth environments

Demonstrated adaptability, thriving in dynamic and evolving business models

Deeply customer- and patient-focused, ensuring solutions create measurable clinical and economic value

Skilled at balancing priorities in the order of
Company Team Self
to drive aligned outcomes

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