Clinical Research Coordinator - 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 a Clinical Research Coordinator, to have overall accountability for the operational conduct of assigned studies, working closely with the Project Manager, Principal Investigator and operational staff and ensuring that all studies are conducted in accordance with regulatory and protocol requirements, and standard operating procedures whilst maintaining the safety and integrity of the study. The Clinical Research Coordinator is the primary site contact for the Project Manager (PM) communicating any potential issues and assists in taking appropriate action in response to these issues, ensuring that client requirements and timelines are always met or exceeded. Undertake moderately complex studies. May mentor and train Clinical Research Coordinators, Operation Coordinators, and junior members of staff, supplying constructive feedback as required.

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: Performs all aspects of the set-up process to include the development and approval of study specific documents, study schedules and clinical procedure planning.

• Coordination: Coordinates the running of critical events, i.e., check in, PK days, check out by resolving/escalating issues identified by both staff and study participants. Monitors and maintains participant safety, dignity, and compliance, including coordination of appropriate medical consultation/treatment as appropriate. Provides updates regarding study participants wellbeing to the investigators and Project Manager including adverse event updates.

• Study Meetings: Facilitates/attends and contributes to all key Study Planning meetings, i.e., Clinical Start Up Meeting, Clinical Planning Meeting, Site Initiation Meeting.

• Protocol Review: Reviews protocols, provides consolidated comments from the clinical site on the draft study protocol to the Project Manager or Medical Writer, considering the logistics, safety (staff and study participants), and site's capabilities. May distributes final protocols and amendments to the site.

• Study Planning: Proactively works with the site to ensure that the laboratory, equipment, and all operational requirements are fulfilled and that the study is adequately resourced. Working closely with the Operations and Pharmacy to ensure dosing runs efficiently and that all documentation is completed accurately within a timely manner. Reviews and creates data source as needed.

• Clients: Is aware of client expectations for trial conduct and works to meet or exceed them. Facilitates client visits and attends client calls with the assistance of the Project Manager where appropriate. Participates in client and process audits by covering study conduct questions.

• Oversees maintenance of study master file ensuring that site related documents are available for uploading to the eTMF.

• Quality: Ensures all protocol deviations and or unscheduled events are properly documented and communicated. Applies lessons learned to prevent recurrence of protocol deviations or errors identified via quality control checks.

• 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.

• Typically, a minimum 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.