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    Sr Cra Ii- Rare Disease

    Syneos Health
    3-5 years
    Preffered by Company
    Remote, USA
    10 Sept. 2, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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

    Location: Sofia, Bulgaria (Hybrid: Office/Remote)

    About Syneos Health®

    Syneos Health® is a leading integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We harness unique clinical, medical affairs, and commercial insights to address modern market challenges and bring innovative therapies to market faster.

    Our Clinical Development model places the customer and patient at the heart of everything we do. We continuously seek ways to simplify and streamline our work to enhance both our client relationships and our work environment.

    Join our team of passionate problem solvers and innovators who are driven to make a difference. Discover why our 29,000 employees in 110 countries believe that:

    WORK HERE MATTERS EVERYWHERE

    Why Syneos Health

    • Career Development: We focus on the growth of our people through career progression, supportive management, technical training, and peer recognition.
    • Inclusive Culture: Our Total Self culture encourages authenticity and inclusivity, creating a workplace where everyone feels they belong.
    • Company Growth: We are committed to building a workplace that everyone wants to be part of, leveraging diverse perspectives and experiences.

    Job Responsibilities

    • Perform site qualification, initiation, interim monitoring, management, and close-out visits (both on-site and remotely) while ensuring compliance with regulatory, ICH-GCP, and/or GPP guidelines and protocols.
    • Evaluate site performance and provide recommendations; escalate serious issues and develop action plans as needed.
    • Ensure informed consent is obtained and documented appropriately, while safeguarding patient confidentiality.
    • Assess site processes, review source documents, verify clinical data accuracy, and resolve queries.
    • Monitor investigational product inventory, security, and compliance with labeling and dispensing protocols.
    • Maintain the Investigator Site File (ISF) and ensure accurate documentation and archiving.
    • Manage site-level activities to meet project objectives, deliverables, and timelines, and adapt to changing priorities.
    • Act as a primary liaison with study site personnel and collaborate with the Central Monitoring Associate.
    • Prepare for and attend Investigator Meetings and sponsor meetings; lead global clinical monitoring staff meetings as needed.
    • Provide supervision, training, and mentorship to junior CRAs and support audit readiness.

    For Real World Late Phase (RWLP) studies:

    • Support site management from identification through close-out.
    • Conduct chart abstraction and data collection, and collaborate with sponsors and local staff.
    • Suggest sites based on local treatment patterns and patient advocacy, and contribute to process improvements.

    Qualifications

    • Bachelor’s degree or RN in a related field or equivalent education, training, and experience.
    • Proficiency in Good Clinical Practice/ICH Guidelines and other regulatory requirements.
    • Strong computer skills and adaptability to new technologies.
    • Excellent communication, presentation, and interpersonal skills, with moderate critical thinking abilities.
    • Ability to travel up to 75% regularly.

    Additional Information

    • Salary: $62,000 to $145,100 annually, based on qualifications, skills, and experience.
    • Benefits: Includes a company car or car allowance, health benefits (medical, dental, vision), 401k match, Employee Stock Purchase Plan, performance-based bonuses, and flexible PTO.
    • COVID-19 Policy: Vaccination is strongly encouraged; proof of vaccination may be required for certain roles based on local regulations or client requirements.

    Apply Now

    At Syneos Health, we believe in creating a thriving environment where our people can develop and succeed. Explore how you can make a meaningful impact with us. Learn more about Syneos Health and apply today!

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