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    Sr Cra I

    Syneos Health
    5+ years
    Not Disclosed
    Remote, USA
    10 Aug. 7, 2024
    Job Description
    Job Type: Full Time Remote 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

    Position: Senior Clinical Research Associate I

    Location: Remote (must reside in the Lubbock, TX area)

    Company Overview:

    Syneos Health® is a leading biopharmaceutical solutions organization dedicated to accelerating customer success. We integrate clinical, medical affairs, and commercial insights to address modern market realities. Our mission is to simplify and streamline our operations, making Syneos Health an excellent place to work and collaborate with. With 29,000 employees across 110 countries, we are committed to delivering therapies that make a difference.

    Why Syneos Health:

    • Career Development: We invest in our people through career growth, supportive management, training, and peer recognition.
    • Inclusive Culture: Our Total Self culture embraces diversity and ensures everyone feels they belong.
    • Innovation and Support: We continuously build a company that aligns with our values and customer needs.

    Job Responsibilities:

    • Conduct site qualification, initiation, interim monitoring, management, and close-out visits (on-site or remotely) while ensuring compliance with regulatory standards, ICH-GCP, and protocols.
    • Evaluate site performance and provide recommendations; escalate serious issues and develop action plans as necessary.
    • Verify informed consent processes and protect patient confidentiality. Assess safety and data integrity at investigator sites.
    • Review source documents and case report forms for accuracy, and drive query resolution.
    • Ensure compliance with electronic data capture requirements and manage investigational product inventory and storage.
    • Maintain accurate records and support site recruitment, retention, and awareness strategies.
    • Manage site-level activities to meet project objectives and timelines; adapt to changing priorities.
    • Act as a liaison with site personnel and support audit readiness and preparation.
    • Provide mentorship to junior CRAs and lead site management tasks under supervision.

    Additional Responsibilities for Real World Late Phase (RWLP):

    • Support sites throughout the study lifecycle, including chart abstraction and data collection.
    • Collaborate with sponsors, medical science liaisons, and local staff to identify operational efficiencies and process improvements.
    • Develop informed consent forms and participate in bid defense meetings.

    Qualifications:

    • Bachelor’s degree or RN in a related field, or equivalent education and experience.
    • Knowledge of Good Clinical Practice/ICH Guidelines and relevant regulatory requirements.
    • Proficiency with computer systems and new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage up to 75% travel regularly.

    About Syneos Health:

    In the past 5 years, Syneos Health has collaborated on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, supporting over 200 studies across 73,000 sites and more than 675,000 trial patients.

    Additional Information:

    The tasks and responsibilities listed are not exhaustive. The company may assign other duties as needed and considers equivalent experience, skills, and education. Syneos Health is committed to compliance with the Americans with Disabilities Act and provides reasonable accommodations when necessary.

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