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    Sponsor Dedicated Cra Ii - Home Based

    Syneos Health
    2+ years
    Not Disclosed
    Remote - Europe
    10 Sept. 9, 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

    Sponsor Dedicated Clinical Research Associate II - Home-Based in Portugal

    Oncology Experience Required

    Syneos Health® is a leading integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We leverage our expertise in clinical, medical affairs, and commercial insights to address modern market challenges and streamline our processes, making Syneos Health both an exceptional partner and employer.

    Join Our Team: Our Clinical Development model places the customer and patient at the heart of everything we do. As part of our team, you will collaborate with passionate problem-solvers and innovators, working together to achieve our clients' goals and accelerate the delivery of transformative therapies. Discover why our 29,000 employees in 110 countries know: Work Here Matters Everywhere.

    Why Syneos Health:

    • Career Development: We are committed to your growth through career progression, comprehensive training, and a supportive management team.
    • Total Self Culture: Our inclusive culture encourages you to be your authentic self, fostering a global environment where everyone feels a sense of belonging.
    • Innovation and Inclusion: We continually strive to create a workplace that blends diverse perspectives and experiences, making it a place where both employees and customers thrive.

    Job Responsibilities:

    • Site Management: Perform site qualification, initiation, monitoring, management, and close-out visits (both on-site and remotely). Ensure compliance with regulatory standards, ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and study protocols. Evaluate site performance, address serious issues, and develop action plans as needed.
    • Informed Consent: Verify that informed consent processes are conducted and documented correctly, ensuring patient confidentiality and addressing any issues related to safety or data integrity.
    • Data Verification: Review site processes, source documents, and medical records. Ensure accuracy and completeness of clinical data in case report forms (CRFs), resolve queries, and support effective data capture and review.
    • Investigational Product (IP) Management: Oversee IP inventory, reconciliation, storage, security, and dispensing according to protocol. Ensure proper labeling, importation, and handling of IP.
    • Document Review: Regularly review and reconcile Investigator Site File (ISF) with the Trial Master File (TMF), ensuring compliance with document archiving requirements.
    • Recruitment and Retention: Support patient recruitment, retention, and awareness strategies. Document site activities and track observations and action items.
    • Project Management: Understand project scope, budgets, and timelines. Manage site-level activities and communications to meet project objectives and adapt to changing priorities.
    • Liaison and Training: Act as a primary liaison with study site personnel and ensure compliance with training requirements. Prepare for and attend investigator meetings, sponsor meetings, and clinical training sessions.
    • Audit Readiness: Provide guidance on audit readiness and support preparation for audits and follow-up actions.

    Additional Responsibilities for Real World Late Phase (RWLP) Studies:

    • Support site activities throughout the study lifecycle.
    • Understand local requirements for late-phase study designs.
    • Perform chart abstraction and data collection.
    • Collaborate with sponsors, medical science liaisons, and local staff.
    • Train junior staff and suggest potential sites based on local knowledge.

    Qualifications:

    • Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
    • Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and regulatory requirements.
    • Proficiency with technology and data management tools.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage up to 75% travel regularly.

    Get to Know Syneos Health: Over the past five years, Syneos Health has been involved in 94% of all Novel FDA-Approved Drugs, 95% of EMA-Authorized Products, and more than 200 studies across 73,000 sites with over 675,000 trial patients. Embrace the opportunity to challenge the status quo and make a significant impact in a dynamic and competitive environment.

    Additional Information: This job description is not exhaustive and may be subject to change. Qualifications may vary based on equivalent experience. Syneos Health is committed to compliance with the Americans with Disabilities Act and providing reasonable accommodations as needed.

    Apply Now: Explore this opportunity and others by joining our Talent Network to stay connected with future career possibilities at Syneos Health.

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