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    Senior Cra Ii - Must Have Early Phase Neurology Expereince - Sponsor Dedicated - Bulgaria (Homebased)

    Syneos Health
    3-5 years
    Not Disclosed
    Bulgaria
    10 Nov. 23, 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 II – Job Description

    Company Overview: Syneos Health® is a global biopharmaceutical solutions organization, dedicated to accelerating customer success by translating clinical, medical, and commercial insights into outcomes that address the complexities of modern market needs. With a focus on collaboration and innovation, Syneos Health is committed to simplifying the clinical development process and making a positive impact on patients' lives.

    Why Syneos Health? Syneos Health values the development of its people through career progression, technical and therapeutic training, and a supportive workplace culture. We believe in creating an inclusive environment where diversity, authenticity, and personal growth are central to success. Our employees are driven by a shared passion to change lives and help customers achieve their goals.

    Key Responsibilities:

    1. Site Management and Monitoring:

      • Perform site qualification, initiation, interim monitoring, and close-out visits, ensuring regulatory compliance, adherence to ICH-GCP, and protocol guidelines.
      • Evaluate site performance, provide recommendations for improvement, and escalate significant issues to the project team for resolution.
      • Verify informed consent procedures, ensuring they are appropriately performed and documented.
      • Assess factors impacting patient safety and clinical data integrity, including protocol deviations and pharmacovigilance issues.

    2. Clinical Data and Compliance:

      • Conduct Source Document Review (SDR) and Source Data Verification (SDV) of clinical trial records and ensure accuracy of case report form (CRF) entries.
      • Address and resolve queries remotely or onsite, ensuring timely closure within agreed timelines.
      • Ensure compliance with electronic data capture (EDC) requirements and review Investigator Site Files (ISF) for accuracy and completeness.
      • Ensure investigational products (IP) are handled and stored according to protocols, and resolve any related issues (e.g., blinding, randomization).

    3. Training, Supervision, and Collaboration:

      • Act as the primary liaison with site personnel or collaborate with the Central Monitoring Associate.
      • Ensure sites and team members are appropriately trained and compliant with study requirements.
      • Mentor and provide training to junior CRAs, including conducting sign-off visits and supporting their development.
      • Participate in investigator meetings and sponsor meetings to ensure alignment with study objectives and timelines.

    4. Documentation and Reporting:

      • Document all monitoring activities including trip reports, communication logs, and follow-up letters in compliance with SOPs.
      • Manage data tracking systems to monitor ongoing site activities, status, and resolution of action items.
      • Prepare and submit reports in line with regulatory and operational standards.

    5. Study Lifecycle Management:

      • Participate in business development proposals, scope definitions, and budgeting for clinical trials.
      • Assist in the design and review of Case Report Forms (CRFs) and ensure informed consent forms are up to date and compliant with local regulations.
      • Identify operational efficiencies and contribute to process improvements to enhance clinical trial execution.

    6. Real-World Late Phase (RWLP) Responsibilities:

      • Support site management throughout the study lifecycle from site identification to close-out.
      • Manage local real-world late-phase studies, chart abstraction activities, and data collection.
      • Collaborate with sponsors, affiliates, and local teams to align on study requirements and local regulations.

    Qualifications:

    • Education: Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
    • Experience: Minimum of 2-4 years of experience in clinical monitoring or site management for a contract research organization (CRO) or pharmaceutical company. Experience in late-phase or oncology studies is preferred but not required.
    • Skills:
      • Strong knowledge of Good Clinical Practice (GCP) and ICH Guidelines.
      • Proficient in the use of clinical trial management systems (CTMS), electronic data capture (EDC), and Investigator Site Files (ISF).
      • Excellent communication, presentation, and interpersonal skills.
      • Strong organizational and time-management abilities.
      • Proficient in using new technologies and systems.
    • Languages: Proficiency in English (both written and spoken). French is a plus.
    • Travel: Willingness to travel up to 75% for site visits and monitoring activities.

    Behavioral Competencies:

    • Critical thinking and problem-solving skills with the ability to manage complex situations.
    • Ability to build and maintain relationships with site staff and other stakeholders.
    • Strong attention to detail and commitment to meeting project timelines.
    • Demonstrated ability to adapt to evolving project requirements and technologies.

    Why work at Syneos Health?
    At Syneos Health, you will have the opportunity to work in a dynamic, collaborative environment where you can develop your skills and make an impact on global clinical research. Join us and be a part of a company committed to improving the lives of patients and the success of our clieNTS.

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