Operations Coordinator I - Dallas, TX

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. Conducting operations in ~100 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, 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)

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. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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If, as a result of a disability, you require a reasonable accommodation to complete your job application, pre-employment testing, job interview or to otherwise participate in the hiring process, please contact: taaccommodationsrequest@fortrea.com. Please note that this e-mail address is only for job seekers requesting an accommodation. Please do not use this e-mail to check the status of your application.