Clinical Research Coordinator I - Dallas, TX

As one of the largest Clinical Research Organizations in the world, we have four Early Phase Clinical Research Units in the UK and US.

We're seeking a Clinical Research Coordinator to oversee the operational conduct of assigned clinical studies. This role partners closely with the Project Manager, Principal Investigator, and site staff to ensure studies are executed in compliance with protocols, regulations, and SOPs, while prioritizing participant safety and data integrity. The Coordinator serves as the primary site contact for the PM, proactively addressing issues and ensuring client expectations and timelines are met. May lead moderately complex studies and mentor junior staff.

This is a full-time, office-based position in Dallas, TX.

If you join us, you will work with some of the worlds leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability, and pharmacokinetics of a new drug.

Many Coordinators are drawn to their profession because of its direct impact on patient care. If this is your case, you will not miss that working in Phase 1 trials. Whilst allowing you to have a close face-to-face relationship with participants, and as you continue to practice your clinical skills and knowledge, youll be involved with the latest medical technologies and treatments, witnessing their development firsthand. When the drug you worked with gets approved, you know youll touch many patients lives around the world.

WHAT YOU WILL DO

You will utilize your skills, knowledge, and clinical judgement to provide a high standard of clinical research.

Other key responsibilities:

• Study Set-Up: Lead development and approval of study-specific documents, schedules, and clinical procedures.

• Event Coordination: Manage key study events (e.g., check-in, PK days, check-out), ensuring participant safety, dignity, and protocol compliance. Escalate issues and coordinate medical consultations as needed.

• Study Meetings: Actively participate in planning meetings including Start-Up, Clinical Planning, and Site Initiation.

• Protocol Review: Evaluate protocols for feasibility and safety; consolidate site feedback and distribute final versions and amendments.

• Operational Planning: Ensure site readiness, including lab, equipment, and staffing. Collaborate with Operations and Pharmacy to support accurate and timely dosing and documentation.

• Client Engagement: Support client expectations through site visits, calls, and audits. Address study conduct inquiries and contribute to continuous improvement.

• Documentation Oversight: Maintain study master file and ensure timely upload of site documents to the eTMF.

• Quality Assurance: Document and communicate protocol deviations and unscheduled events. Apply lessons learned to improve future study conduct.

• All other duties as needed or assigned.

YOU NEED TO BRING...

• University/college degree desirable (life science, pharmacy or related subject preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).

• In lieu of a degree, typically 3 years' experience in a related field will be considered.

• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

• 3-4 years' experience in a research environment.

• Knowledge of protocol designs, study objectives and study procedures.

• Knowledge of drug development process, ICH guidelines and GCP.

• Previous customer service experience desirable.

• Previous experience of coordinating people or processes desirable.

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.

What do you get?

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)

Learn more about our EEO & Accommodations request here.