Employment Type: Permanent Position

Job Category: Clinical Research / Trial Operations

Department: Clinical Operations

Reports To (Position): Director of Clinical Operations

Job Number: 3323074

Position Overview

We are seeking a Senior Clinical Research Associate to lead the execution of clinical trials across multiple diagnostic studies. This role is pivotal in ensuring protocol compliance, efficient site management, and high-quality data collection — all while supporting national trial expansion.

This is a long-term career opportunity with significant room for advancement. We offer a clear path for professional growth, including support toward SOCRA CRA certification and leadership development opportunities.

Responsibilities

• Lead the planning, execution, and monitoring of diagnostic clinical trials
• Oversee protocol development, CRF design, and site-level contracting and budgeting
• Serve as the primary liaison between sites — ensuring clear communication, support, and compliance
• Manage IRB submissions and regulatory documentation
• Develop and execute monitoring plans; conduct site qualification, initiation, monitoring, and close-out visits
• Ensure timely resolution of queries, deviations, and data issues
• Maintain and update Diagnostica, company’s proprietary CTMS platform
• Provide mentorship to junior CRAs and support process optimization as the team grows
• Collaborate closely with project managers, regulatory, and lab teams to align on study goals

Qualifications / Skills

• 2–4 years of clinical research experience, with at least 1 year as a CRA or senior CRC with audit experience
• Proven ability to manage multiple sites and studies independently
• Deep knowledge of Good Clinical Practice (GCP) and FDA/IVD study requirements
• Exceptional organizational, communication, and problem-solving skills
• Experience with site budgeting and contract negotiation is a plus
• Comfortable working in a fast-paced, entrepreneurial environment
• Willingness to travel as needed (20–30%)
• SOCRA or ACRP certification (or willingness to pursue with support) 

The physical demands and work environment that have been described are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions in accordance with the Americans with Disabilities Act.

The above job description is an overview of the functions and requirements for this position. This document is not intended to be an exhaustive list encompassing every duty and requirement of this position; your supervisor may assign other duties as considered necessary.