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    Sr Cra Ii

    Syneos Health
    2+ years
    Not Disclosed
    Remote, USA
    10 Sept. 17, 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

    Position Title: Senior Clinical Research Associate II

    Company: Syneos Health®

    Location: Multiple Locations (Home-Based / Hybrid / Office-Based)

    Company Overview:

    Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage unique clinical, medical, and commercial insights to address modern market challenges. Our Clinical Development model places the customer and patient at the center of our work, continuously seeking ways to enhance efficiency and simplify processes.

    Joining us means becoming part of a collaborative team that values innovation and is driven to deliver therapies that transform lives. With 29,000 employees across 110 countries, we are united by the belief that WORK HERE MATTERS EVERYWHERE.

    Why Syneos Health?

    • Career Development: We are committed to fostering career growth through progression opportunities, supportive management, specialized training, peer recognition, and a comprehensive rewards program.
    • Inclusive Culture: Our Total Self culture ensures you can be your authentic self, contributing to a global environment where diversity of thought and perspective is valued.
    • Impactful Work: We continuously strive to create an organization where our people and customers thrive, embracing diverse perspectives to foster a sense of belonging.

    Key Responsibilities:

    • Site Management: Conduct site qualification, initiation, interim monitoring, and close-out visits (both on-site and remote). Ensure compliance with regulatory requirements, ICH-GCP, and protocols. Evaluate site performance, address serious issues, and develop action plans.
    • Informed Consent: Verify that informed consent is obtained and documented correctly. Protect patient confidentiality and address factors impacting patient safety and data integrity.
    • Data Review: Review site source documents and medical records, ensuring accuracy and completeness of clinical data. Resolve queries and provide guidance to site staff.
    • Investigational Product (IP) Management: Oversee IP inventory, reconciliation, and storage. Ensure proper handling and compliance with protocols regarding IP dispensing and administration.
    • Documentation: Maintain and reconcile Investigator Site File (ISF) with Trial Master File (TMF). Ensure essential documents are archived as required. Document site activities and manage subject recruitment and retention.
    • Project Management: Understand project scope, budgets, and timelines. Manage site-level activities and communication to meet project objectives and adapt to changing priorities.
    • Training & Mentorship: Provide training and mentorship to junior CRAs. Lead and participate in global monitoring/project staff meetings and audit preparations.
    • Real World Late Phase (RWLP) Responsibilities: For RWLP studies, support site activities from identification through close-out, collaborate with sponsors and local staff, and contribute to study design and regulatory compliance.

    Qualifications:

    • Education: Bachelor’s degree or RN in a relevant field or equivalent combination of education and experience.
    • Experience: Proficiency in Good Clinical Practice (GCP), ICH Guidelines, and other regulatory requirements. A minimum of 3 years of relevant experience is preferred.
    • Skills: Strong communication, presentation, and interpersonal skills. Proficient in using technology and managing up to 75% travel.
    • Critical Thinking: Moderate level of critical thinking skills required.

    Additional Information:

    • Salary: The annual base salary ranges from $62,000 to $145,100, depending on qualifications and experience.
    • Benefits: Includes a company car or car allowance, comprehensive health benefits (Medical, Dental, Vision), 401k match, Employee Stock Purchase Plan, performance-based bonuses, and flexible paid time off (PTO) and sick time.
    • COVID-19 Policy: We encourage COVID-19 vaccination and adhere to local or client-specific vaccine requirements. Proof of vaccination may be required.

    Application:

    Become a part of our dynamic team where your work has a meaningful impact. Apply now at Syneos Health Careers.

    Equal Opportunity Employer:

    Syneos Health is committed to creating a diverse environment and is proud to be an equal opportunity employer. We comply with all applicable regulations and provide reasonable accommodations to support our employees.

    Note: This job description provides a general overview of the position. Responsibilities and qualifications may evolve based on company needs and project requirements.

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