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    Cra Ii- Scra Ii (Melbourne/ Sydney)

    Syneos Health
    2+ years
    Not Disclosed
    Remote
    10 Oct. 22, 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

    Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities.

    Our Clinical Development model puts the customer and the patient at the center of everything we do. We continuously seek ways to simplify and streamline our operations, making Syneos Health easier to work with—and for.

    Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.

    Discover why our 29,000 employees across 110 countries believe: WORK HERE MATTERS EVERYWHERE.

    Why Syneos Health?

    • Career Development: We invest in your growth through career progression, supportive management, technical training, and peer recognition.
    • Total Self Culture: Our inclusive culture encourages you to be your authentic self, fostering a sense of belonging.
    • Diversity: We bring together diverse thoughts, backgrounds, and perspectives to create a workplace where everyone feels valued.

    Key Responsibilities:

    • Site Management: Perform site qualification, initiation, interim monitoring, and close-out visits (both on-site and remotely) while ensuring compliance with regulatory standards, ICH-GCP, and Good Pharmacoepidemiology Practice (GPP).
    • Data Integrity: Verify informed consent processes, assess factors affecting patient safety, and ensure clinical data integrity.
    • Monitoring Activities: Assess site processes, conduct source document reviews, and verify clinical data accuracy in case report forms (CRFs).
    • Query Resolution: Apply query resolution techniques and provide guidance to site staff to drive timely resolutions.
    • Inventory Management: Oversee investigational product (IP) inventory and compliance, ensuring appropriate handling and documentation.
    • Documentation: Maintain accurate Investigator Site Files (ISF), reconcile them with the Trial Master File (TMF), and support audit readiness.
    • Communication: Act as a liaison with study site personnel and participate in investigator meetings, ensuring all team members are trained and compliant.
    • Project Management: Understand project scope, budgets, and timelines, managing site-level activities to meet objectives.

    For Real World Late Phase Studies:

    • Site Management Associate II: Support sites throughout the study lifecycle, from identification to close-out, and engage in chart abstraction and data collection.
    • Collaboration: Work with Sponsor affiliates, medical science liaisons, and local staff, while identifying potential sites based on local healthcare knowledge.

    Qualifications:

    • Education: Bachelor’s degree or RN in a related field, or equivalent experience.
    • Knowledge: Familiarity with Good Clinical Practice (GCP) and ICH guidelines.
    • Skills: Strong computer skills and adaptability to new technologies; excellent communication and interpersonal skills.
    • Travel: Ability to manage travel of up to 75% regularly.

    Get to Know Us:

    Over the past five years, we’ve collaborated on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and conducted over 200 studies across 73,000 sites with more than 675,000 trial patients.

    Join Us: If you’re ready to take on this exciting CRA II role and make a meaningful impact in clinical research, we want to hear from you!

    Additional Information:

    This job description is not exhaustive and may be adjusted at the company's discretion. Equivalent experience will be considered. This posting complies with applicable laws and regulations, including the Americans with Disabilities Act, providing reasonable accommodations as needed.

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