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    Home-Based Senior Cra The Netherlands

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

    Senior Clinical Research Associate - The Netherlands

    Syneos Health®

    About Syneos Health
    Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization committed to accelerating customer success. We leverage unique clinical, medical affairs, and commercial insights to address the complexities of modern market realities.

    Our Clinical Development model centers on the customer and the patient, and we are continuously seeking ways to simplify and streamline our processes. Whether you join us in a Functional Service Provider (FSP) partnership or a Full-Service environment, you will collaborate with a passionate team dedicated to accelerating the delivery of therapies that will change lives.

    Why Syneos Health?
    At Syneos Health, we are committed to career development, offering opportunities for progression, training, and recognition. Our Total Self culture promotes being your authentic self, helping us to create an environment where everyone belongs.

    Job Responsibilities

    • Site Monitoring & Management: Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remotely). Ensure compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and study protocols. Evaluate site performance and escalate issues when necessary.
    • Informed Consent & Patient Safety: Ensure informed consent is correctly obtained and documented. Safeguard patient confidentiality and assess potential risks affecting safety and data integrity.
    • Data Management & Query Resolution: Review site source documents and medical records to verify clinical data accuracy. Resolve data queries remotely or on-site, ensuring timely resolution.
    • Investigational Product (IP) Management: Oversee IP inventory, security, and compliance. Ensure IP is dispensed and administered per protocol.
    • Documentation & Reporting: Ensure accurate documentation of site activities, including confirmation letters and trip reports. Support patient recruitment and retention strategies, track action items to resolution.
    • Project Management: Manage site-level activities to meet project objectives and timelines. Adapt to changing priorities to ensure goals are met.
    • Audit Preparation: Maintain audit readiness, assist in audit preparations, and provide follow-up actions when necessary.
    • Real World Late Phase (RWLP): Support Real World Late Phase studies, including site management, data collection, and chart abstraction. Collaborate with local and global teams to ensure compliance with local regulations.
    • Mentorship & Training: Provide training and mentorship to junior CRAs. Participate in the development of informed consent forms and identify operational improvements.

    Qualifications

    • Bachelor’s degree or RN in a related field or equivalent combination of education and experience.
    • Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other applicable regulatory requirements.
    • Strong computer skills and willingness to embrace new technologies.
    • Excellent communication, presentation, and interpersonal skills. Basic critical thinking ability required.
    • Fluency in Dutch and proficiency in English.
    • Ability to travel across The Netherlands for site monitoring visits.

    About Syneos Health
    Over the past 5 years, Syneos Health has worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and conducted over 200 studies across 73,000 sites and 675,000+ trial patients. Join us in driving innovation and challenging the status quo in a dynamic, ever-changing environment.

    Additional Information
    The responsibilities outlined in this job description are not exhaustive. Syneos Health reserves the right to modify or assign additional tasks, duties, or responsibilities as needed. Equivalent experience and qualifications will be considered. All applicants will be evaluated in compliance with local legislation, including the EU Equality Directive.

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