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, which will be responsible for practical/administrative activities in support of a clinical research trial. The role will support and assist 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:

• Responsible for logistical set-up of study 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.

• Assists and/or is responsible for the creation of source documents, labels, and study specific instructions.

• Assists and/or is responsible for creation of study schedules.

• Orders supplies/equipment and dietary needs for assigned studies.

• Liaises with CRU contracted services, such as clinical labs and ECG services.

• Assists and/or is responsible for staff training of study specific procedures.

• Coordinates tasks related to participant check-in and discharge and may assist with resolution of participant issues.

• Is present in the clinical work areas for critical events or as assigned by a senior team member.

• Completes sample shipment documentation, as necessary. May assist with sample shipments as needed.

• Compiles data tables/summaries as requested.

• Assists with on-time CRF completion and query process as appropriate.

• Assists with the compilation of protocol and SOP deviations.

• Provide logistical feasibility for protocol development.

• Attends all required meetings as appropriate.

• Maintains skills to perform study tasks and assists with study procedures, as necessary.

• Maintains accurate records of all work undertaken.

• Maintains an understanding of FDA, GCP and ICH requirements.

• Maintains constant awareness of participant safety and dignity at all times.

• Ensures that client and participant confidentiality is maintained.

• Responds to team queries in a timely manner.

• Takes ownership for the quality and standard of own work.

• Evaluates current SOP's and authors additions/revisions.

• Train and instruct less experienced staff.

• 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 (e.g., pharmaceutical, laboratory, data analysis) will be considered in addition to the experience requirement.

• Basic Life Support Skills (BLS) or CPR/AED Certified.

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

• 1-2 years of professional work experience with at least one year's experience in clinical research.

• Basic knowledge of computers and programs (e.g., Microsoft Word, Excel).

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

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.