Operations 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 are currently seeking an Operations Coordinator I, responsible for practical/administrative activities in support of a clinical research trial. This role supports and assists the senior study team members such as the Clinical Research Coordinator and Project Manager as appropriate.

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.

WHAT YOU WILL DO

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

Other key responsibilities:

• Support study logistics by coordinating setup, scheduling, and resource allocation to ensure smooth study execution.

• Assist Clinical Research Coordinators and serve as a backup, contributing to source documentation, study instructions, and CRF completion.

• Manage study-specific materials including supplies, equipment, dietary needs, and liaise with contracted services (e.g., labs, ECG).

• Facilitate participant check-in/discharge, address participant concerns, and ensure safety, dignity, and confidentiality throughout the study.

• Lead or support staff training in study procedures and protocol adherence; evaluate and revise SOPs as needed.

• Maintain accurate records, compile data summaries, and assist with protocol/SOP deviation tracking and query resolution.

• Provide logistical input during protocol development and attend required meetings to ensure alignment across teams.

• Train and mentor junior staff, uphold quality standards, and stay current with FDA, GCP, and ICH guidelines.

• All other duties as needed or assigned.

YOU NEED TO BRING...

• University/college degree (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 2 years' experience in a related field will be considered in addition to the experience requirement.

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

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

• Knowledge of computers and programs (e.g., word processing and spreadsheet applications).

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.