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    Sponsor Dedicated Cra Ii - Home Based Portugal

    Syneos Health
    2+ years
    Not Disclosed
    Remote, USA
    10 Nov. 18, 2024
    Job Description
    Job Type: Full Time 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

    Sponsor Dedicated Clinical Research Associate II - Home Based Portugal

    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 the customer and patient at the center of everything we do. We continuously strive to simplify and streamline processes to make 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, driven, and passionate about delivering therapies that change lives.

    Why Syneos Health We are committed to developing our people through career growth, supportive management, therapeutic training, peer recognition, and a robust total rewards program. Our Total Self culture, where you can authentically be yourself, unites us globally and allows us to take care of our people.

    We aim to create an inclusive environment where everyone feels like they belong and where diversity of thought, background, culture, and perspectives makes us stronger.

    Job Responsibilities

    • Perform site qualification, initiation, interim monitoring, management activities, and close-out visits (either on-site or remotely) ensuring compliance with regulatory, ICH-GCP, and protocol standards. Evaluate site performance and develop action plans for improvement while escalating serious issues promptly.
    • Ensure informed consent is properly obtained and documented. Safeguard confidentiality and assess potential risks affecting patient safety and clinical data integrity.
    • Conduct source document reviews, ensure accurate clinical data entry, resolve queries, and ensure compliance with electronic data capture requirements.
    • Manage investigational product (IP) inventory, ensure proper dispensation and security, and verify proper protocol compliance.
    • Review Investigator Site Files (ISF) for accuracy and ensure compliance with archiving regulations.
    • Document activities through trip reports, communication logs, and other required project documentation. Contribute to patient recruitment and retention strategies.
    • Maintain understanding of project scope, budgets, timelines, and adapt to changing priorities as needed.
    • Act as a liaison with study site personnel and collaborate with Central Monitoring Associates. Ensure proper training and compliance for assigned sites.
    • Attend Investigator Meetings, sponsor face-to-face meetings, and participate in clinical training sessions.
    • Support audit readiness standards and assist with audit preparation and follow-up actions.

    Qualifications

    • Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience.
    • Minimum of 2 years of experience as a Clinical Research Associate.
    • Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other relevant regulatory requirements.
    • Strong computer skills and adaptability to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage up to 75% travel regularly.

    About Syneos Health With over 29,000 employees across 110 countries, Syneos Health has worked on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, conducting over 200 studies across 73,000 sites with over 675,000 trial patients.

    Join us in making an impact. Work here. It matters everywhere.

    Additional Information The duties and responsibilities listed in this job description are not exhaustive and may evolve. The company reserves the right to modify the job description as necessary. Equivalent experience, skills, or education may also be considered. This is not intended to create an employment contract. The company is committed to compliance with applicable labor laws, including the Americans with Disabilities Act, providing reasonable accommodations when needed.

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