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

3-5 years
Not Disclosed
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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