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    Operations Coordinator

    Fortrea
    1-2 years
    Not Disclosed
    Dallas
    10 Aug. 2, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    As a leading global contract research organization (CRO) with a deep commitment to scientific excellence and extensive experience in clinical development, Fortrea offers pharmaceutical, biotechnology, and medical device companies a comprehensive suite of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With a dedicated workforce of over 19,000 professionals operating in more than 90 countries, Fortrea is at the forefront of advancing drug and device development globally.

    We are excited to announce an opportunity within our Centralized Delivery Hub in Dallas, TX. We are seeking an Operations Coordinator to ensure the efficient logistical setup of studies, facilitating smooth operations and adequate resource allocation. As an integral member of our team, you will support the Clinical Research Coordinator and act as their backup as needed. You will gain exposure to a wide variety of therapeutic indications and study types, including ascending dose studies, first-in-human trials, food effect studies, and drug-to-drug interaction evaluations.

    Position: Operations Coordinator
    Location: Dallas, TX
    Type: Full-time, Office-based

    Key Responsibilities:

    • Create e-source documents, labels, and study-specific instructions.
    • Host clinical planning meetings for each stage of study start-up.
    • Develop and manage study schedules.
    • Order and coordinate supplies, equipment, and dietary needs for studies.
    • Liaise with contracted services (e.g., clinical labs, ECG services).
    • Train staff on study-specific procedures and protocols.
    • Coordinate participant check-in, discharge, and issue resolution.
    • Complete sample shipment documentation and compile data tables and summaries.
    • Ensure timely completion of Case Report Forms (CRFs) and manage related queries.
    • Document and track protocol and SOP deviations.
    • Provide logistical feasibility for protocol development and maintain accurate work records.
    • Stay updated on FDA, GCP, and ICH requirements, ensuring client and participant confidentiality.
    • Evaluate and revise Standard Operating Procedures (SOPs).
    • Assist with form reviews and activity plans for bedside data capture.
    • Perform additional duties as needed or assigned.

    Qualifications:

    • University/college degree in life sciences, pharmacy, or a related field preferred, or certification in a related allied health profession (e.g., nursing, medical or laboratory technology) from an accredited institution. Equivalent relevant experience may be considered.
    • 1-2 years of professional work experience, including at least 1 year in clinical research.
    • Basic Life Support (BLS) or CPR/AED certification.
    • Ability to work in a fast-paced environment with strict adherence to study protocols and timelines.
    • Strong teamwork and interpersonal skills are essential for smooth study operations.
    • Proficiency with technology and electronic data collection systems.

    What We Offer:

    • Comprehensive benefits package for full-time and part-time employees working 20 or more hours per week, including medical, dental, vision, life insurance, and STD/LTD coverage.
    • 401(K) plan.
    • Paid Time Off (PTO).
    • Employee recognition awards.
    • Access to multiple Employee Resource Groups (ERGs).

    Fortrea is dedicated to overcoming challenges in clinical trials and revolutionizing the development process to deliver transformative therapies to patients. By joining our team, you will be part of a dynamic and collaborative environment that supports personal and professional growth, allowing you to make a significant global impact. For more information, visit www.fortrea.com.

    Equal Opportunity Employer:

    Fortrea is an Equal Opportunity Employer committed to diversity and inclusion. We do not tolerate harassment or discrimination and make employment decisions based on business needs and individual qualifications. We encourage all qualified individuals to apply.

    For details on how we collect and store your personal data, please review our Privacy Statement.

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