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    Cra Ii (Cz) - Sponsor-Dedicated

    Syneos Health
    2+ years
    Not Disclosed
    Remote - Europe Remote, USA
    10 Nov. 4, 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, 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

    Description
    Syneos Health® is a premier fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We convert unique clinical, medical affairs, and commercial insights into actionable outcomes that address today’s market realities.

    Our Clinical Development model places the customer and the patient at the forefront of everything we do. We are constantly seeking innovative ways to simplify and enhance our processes, making Syneos Health easier to work with and for.

    In either a Functional Service Provider partnership or a Full-Service environment, you’ll join a team of passionate problem solvers, collaborating to help our customers meet their goals. We are agile and motivated to speed up therapy delivery, driven by our commitment to changing lives.

    Why Syneos Health?
    We are committed to the development of our people through career progression, supportive management, technical training, peer recognition, and a comprehensive rewards program. Our Total Self culture fosters an environment where you can be your authentic self, uniting us globally and ensuring everyone feels they belong.

    Job Responsibilities

    • Conduct site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely) to ensure compliance with regulatory standards, ICH-GCP, and Good Pharmacoepidemiology Practice (GPP). Utilize judgment and experience to assess site performance and escalate serious issues to the project team, developing action plans as needed.
    • Ensure informed consent processes are correctly executed and documented, maintaining confidentiality and assessing factors that may impact subject safety and data integrity.
    • According to the Clinical Monitoring/Site Management Plan (CMP/SMP):
      • Evaluate site processes and perform source document reviews.
      • Confirm that clinical data entered in case report forms (CRFs) is accurate and complete.
      • Apply query resolution techniques both remotely and on-site, guiding site staff as necessary.
      • Use available technology to facilitate effective clinical study data review and ensure compliance with electronic data capture requirements.
    • Oversee investigational product (IP) inventory, ensuring proper dispensing and administration according to protocols while managing risks associated with blinded or randomized information.
    • Regularly review the Investigator Site File (ISF) for accuracy and completeness, reconciling it with the Trial Master File (TMF) and ensuring compliance with archiving requirements.
    • Document activities via confirmation letters, follow-up communications, trip reports, and other project documents per SOPs and the Clinical Monitoring Plan/Site Management Plan. Support subject recruitment and retention initiatives.
    • Understand project scope, budgets, and timelines; manage site-level communication to meet project objectives, adapting to changing priorities as necessary.
    • Act as a primary liaison with study site personnel and ensure compliance among project-specific site team members.
    • Prepare for and attend Investigator Meetings and participate in global clinical monitoring meetings as required.
    • Maintain a working knowledge of ICH/GCP Guidelines and complete necessary training.

    For Real World Late Phase:

    • Provide site support throughout the study lifecycle from site identification to close-out.
    • Conduct chart abstraction activities and collaborate with Sponsor affiliates and local teams.
    • May train junior staff and communicate out-of-scope activities to the Lead CRA/Project Manager.

    Qualifications

    • Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
    • Familiarity with Good Clinical Practice/ICH Guidelines and relevant regulatory requirements.
    • Strong computer skills and the ability to adapt to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Willingness to travel up to 75% regularly.

    Get to Know Syneos Health
    In the last five years, we have collaborated on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and completed over 200 studies across 73,000 sites, involving more than 675,000 trial patients.

    No matter your role, you’ll take initiative and challenge the status quo in a highly competitive and ever-changing environment. Learn more about Syneos Health.

    Additional Information
    The responsibilities outlined in this job description are not exhaustive. The company may assign additional tasks at its discretion. Equivalent experience, skills, and education will also be considered. This description complies with all obligations imposed by legislation in each operating country, including the EU Equality Directive. The company is committed to the Americans with Disabilities Act and will provide reasonable accommodations when appropriate.

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