Clinical Research Coordinator I, Early Phase Clinical Research - Dallas, TX

Fortrea•Dallas, TX

About The Position

Join one of the world’s largest Clinical Research Organizations and support early-phase clinical trials in a fast‑paced, highly collaborative environment. As a Clinical Research Coordinator, you will oversee the operational execution of assigned studies, ensuring compliance with protocols, regulations, and SOPs while maintaining participant safety and data integrity. In this role, you’ll work closely with Project Managers, Principal Investigators, and site teams, serving as the primary site contact for study updates, issue escalation, and client requirements. You may also mentor junior staff and support moderately complex studies. What You’ll Do Lead study start-up activities, including developing study-specific documents, schedules, and procedures. Coordinate key study events (check‑ins, PK days, check‑outs), ensuring participant safety, comfort, and protocol adherence. Attend and contribute to study meetings (e.g., Start-Up, Planning, Site Initiation). Review study protocols and provide site feedback on feasibility, logistics, and safety considerations. Partner with Operations, Pharmacy, and lab teams to ensure readiness, proper resourcing, and smooth dosing processes. Support client interactions, including visits, calls, and audits. Maintain accurate study documentation and oversee contributions to the eTMF. Identify and document protocol deviations and support quality improvement efforts. Complete other duties as assigned. What You Bring Bachelor’s degree in life sciences, pharmacy, or related field preferred; clinical/technical certifications accepted. 3+ years of experience in a clinical research or related environment (experience may substitute for education). Knowledge of study protocols, ICH/GCP guidelines, and the drug development process. Strong coordination, communication, and problem‑solving skills. Customer service or team coordination experience preferred. Work Environment: Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment. Occasional drives to site locations, occasional domestic travel. Exposure to biological fluids. Personal protective equipment required such as protective eyewear, garments, and gloves. Physical Requirements: Ability to work in an upright and /or stationary position for 6-8 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Regular and consistent attendance. Varied hours may be required. The important thing for us is you are comfortable working in an environment that is: Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue. Changing priorities constantly asking you to prioritize and adapt on the spot. Teamwork and people skills are essential for the study to run smoothly. Technology based. We collect our data directly into an electronic environment.

Requirements

Bachelor’s degree in life sciences, pharmacy, or related field preferred; clinical/technical certifications accepted.
3+ years of experience in a clinical research or related environment (experience may substitute for education).
Knowledge of study protocols, ICH/GCP guidelines, and the drug development process.
Strong coordination, communication, and problem‑solving skills.

Nice To Haves

Customer service or team coordination experience preferred.
Experience coordinating people or processes; customer‑service experience helpful.

Responsibilities

Lead study start-up activities, including developing study-specific documents, schedules, and procedures.
Coordinate key study events (check‑ins, PK days, check‑outs), ensuring participant safety, comfort, and protocol adherence.
Attend and contribute to study meetings (e.g., Start-Up, Planning, Site Initiation).
Review study protocols and provide site feedback on feasibility, logistics, and safety considerations.
Partner with Operations, Pharmacy, and lab teams to ensure readiness, proper resourcing, and smooth dosing processes.
Support client interactions, including visits, calls, and audits.
Maintain accurate study documentation and oversee contributions to the eTMF.
Identify and document protocol deviations and support quality improvement efforts.
Complete other duties as assigned.