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    Cra Ii

    Syneos Health
    5+ years
    Not Disclosed
    Remote, USA
    10 Sept. 19, 2024
    Job Description
    Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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

    Clinical Research Associate II

    Company Overview

    Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage unique clinical, medical affairs, and commercial insights to address modern market realities. Our Clinical Development model places both the customer and the patient at the center of everything we do, continuously seeking ways to simplify and enhance our operations for the benefit of all.

    Join us, and collaborate with passionate problem solvers who innovate as a team to help our customers achieve their goals. With 29,000 employees across 110 countries, we know that WORK HERE MATTERS EVERYWHERE.

    Why Syneos Health?

    We are committed to developing our people through career advancement, supportive management, comprehensive training, peer recognition, and a total rewards program. Our Total Self culture fosters authenticity and unity, allowing everyone to feel they belong. Together, we are building a workplace that meets the needs of our employees and our customers.

    Job Responsibilities

    • Conduct site qualification, initiation, interim monitoring, management, and close-out visits—either on-site or remotely—ensuring compliance with regulatory standards, ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and study protocols.
    • Evaluate site performance, communicate serious issues to the project team, and develop action plans as needed.
    • Verify that the informed consent process is adequately documented and that patient confidentiality is upheld.
    • Assess safety and data integrity at investigator sites, addressing protocol deviations and pharmacovigilance issues.
    • Perform Source Document Reviews and ensure the accuracy and completeness of clinical data entered in case report forms (CRFs).
    • Resolve queries efficiently, providing guidance to site staff to ensure timely closure within agreed timelines.
    • Manage investigational product (IP) inventory, ensuring compliance with protocols for dispensing and administration.
    • Review the Investigator Site File (ISF) for accuracy and completeness, reconciling it with the Trial Master File (TMF).
    • Document all activities according to SOPs, including communication logs, trip reports, and follow-up letters.
    • Support subject recruitment and retention strategies, and track observations and action items to resolution.
    • Serve as the primary liaison with study site personnel, ensuring compliance and training for site team members.
    • Prepare for and participate in Investigator Meetings and global clinical monitoring/project staff meetings.
    • Maintain audit readiness standards and support preparation for audits and follow-up actions.

    For Real World Late Phase studies, you will also:

    • Provide site support throughout the study lifecycle, from identification to close-out.
    • Conduct chart abstraction activities and collaborate with Sponsor affiliates and local country staff.
    • Train junior staff as needed and suggest potential sites based on local knowledge of treatment patterns.

    Qualifications

    • Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
    • Strong understanding of Good Clinical Practice (GCP), ICH Guidelines, and relevant regulatory requirements.
    • Proficient in computer skills and adaptable to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Willingness to travel up to 75% regularly.

    About Syneos Health

    In the past five years, we have partnered on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, overseeing over 200 studies across 73,000 sites with more than 675,000 trial patients. Join us in taking initiative and challenging the status quo in a dynamic and competitive environment.

    Additional Information:
    This job description is not exhaustive; the company may assign other tasks and responsibilities at its discretion. Equivalent experience and skills will also be considered. This description aims to comply with all applicable legislation regarding recruitment and employment, including provisions for reasonable accommodations under the Americans with Disabilities Act.

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