As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.
With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
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, to be responsible for the logistical set up of studies to ensure good study flow and adequate resources are assigned.
Assists the Clinical Research Coordinator with their responsibilities and acts as their back-up, as needed. Each day is different, you will be exposed to a wide variety of Therapeutic Indications and study types (ascending dose, first-in-human, food effect, drug to drug interactions, etc.)
This is a full-time, office-based position in Dallas, TX.
If you join us, you will work with some of the world s 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 practice your clinical skills and knowledge, you ll be involved with the latest medical technologies and treatments, witnessing their development firsthand.
When the drug you worked with gets approved, you know you ll touch many patient s 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 :
Create source documents, labels, and study-specific instructions.
Develop study schedules.
Order supplies, equipment, and dietary needs for studies.
Liaise with CRU contracted services (e.g., clinical labs, ECG services).
Train staff on study-specific procedures.
Coordinate participant check-in, discharge, and issue resolution.
Complete sample shipment documentation.
Compile data tables and summaries.
Ensure timely CRF completion and manage queries.
Compile protocol and SOP deviations.
Provide logistical feasibility for protocol development.
Maintain accurate work records.
Stay updated on FDA, GCP, and ICH requirements.
Ensure client and participant confidentiality is maintained.
Evaluate and revise SOPs.
Assist with form reviews and activity plans on bedside date capture.
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).
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
1-2 years of professional work experience with at least 1 year experience in clinical research.
Basic Life Support Skills (BLS) or CPR / AED Certified.
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)
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials.
Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.
Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.