Clinical Research Coordinator I, Early Phase Clinical Research - Dallas, TX
About the role
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.
Responsibilities
- Lead study start-up activities, including developing study-specific documents, schedules, and procedures.
- Cook up 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.
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.
- Customer service or team coordination experience preferred.
Qualifications
- 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.
Skills
- 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.
Benefits
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.
Pay
Regular, full-time, or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to: Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers), 401(K), Paid time off (PTO), Employee recognition awards, Multiple ERG’s (employee resource groups).
Schedule
Regular, full-time, or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to: Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers), 401(K), Paid time off (PTO), Employee recognition awards, Multiple ERG’s (employee resource groups).