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    Experienced Cra Denmark

    Syneos Health
    2+ years
    Not Disclosed
    Remote, USA
    10 Oct. 7, 2024
    Job Description
    Job Type: 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

    Clinical Research Associate (CRA) – Denmark

    Company Overview:

    Syneos Health® is a premier, fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into actionable outcomes that address contemporary market realities. Our Clinical Development model places the customer and the patient at the heart of everything we do. We are constantly seeking ways to simplify and streamline our processes, making Syneos Health not only easy to work with but also a great place to work.

    Join us in a Functional Service Provider partnership or a Full-Service environment where you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, motivated by our commitment to changing lives.

    Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE.

    Why Syneos Health:

    We are passionate about developing our people through career advancement opportunities, supportive management, technical and therapeutic training, peer recognition, and a comprehensive total rewards program. Our Total Self culture encourages authenticity, fostering a global community where everyone feels valued and included.

    Job Responsibilities:

    • Perform site qualification, initiation, interim monitoring, management, and close-out visits (both on-site and remotely), ensuring compliance with regulatory standards, ICH-GCP guidelines, and study protocols. Use judgment and experience to evaluate site performance and escalate serious issues as necessary.
    • Verify that informed consent processes are properly executed and documented for each subject/patient, protecting their confidentiality and assessing safety and data integrity.
    • Follow the Clinical Monitoring/Site Management Plan (CMP/SMP) by:
      • Assessing site processes.
      • Conducting source document reviews and verifying the accuracy and completeness of clinical data in case report forms (CRFs).
      • Applying query resolution techniques and guiding site staff to resolve queries within agreed timelines.
      • Ensuring compliance with electronic data capture requirements.
    • Oversee investigational product (IP) inventory and security, ensuring adherence to protocol for dispensation and administration to subjects/patients.
    • Regularly review the Investigator Site File (ISF) for accuracy and completeness, reconciling it with the Trial Master File (TMF).
    • Document activities through confirmation letters, trip reports, and other project documents, tracking observations and action items.
    • Understand project scope, budgets, and timelines, managing site-level activities to meet objectives and adapt to changing priorities.
    • Act as the primary liaison with study site personnel or in collaboration with Central Monitoring Associates, ensuring compliance and training for all assigned sites.
    • Prepare for and attend Investigator Meetings and sponsor meetings, contributing to global project staff meetings and clinical training sessions.
    • Support audit readiness and preparation, ensuring compliance with audit standards.
    • Provide mentorship and training to junior CRAs, including conducting training and sign-off visits.
    • Participate in business development proposals and defense meetings as assigned, under the guidance of an experienced Clinical Operations Lead (COL) or operational line manager.

    Qualifications:

    • Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
    • Strong knowledge of Good Clinical Practice (GCP), ICH Guidelines, and applicable regulatory requirements.
    • Previous monitoring experience in Denmark is preferred.
    • Proficient computer skills and a willingness to embrace new technologies.
    • Excellent communication, presentation, and interpersonal skills, with a moderate level of critical thinking expected.
    • Fluency in Danish and proficiency in English.
    • Ability to manage regular travel throughout Denmark and occasionally in the wider Nordics region.

    Get to Know Syneos Health:

    Over the past five years, we have collaborated on 94% of all novel FDA-approved drugs, 95% of EMA-authorized products, and over 200 studies across 73,000 sites and 675,000+ trial patients.

    No matter your role, you’ll be empowered to take initiative and challenge the status quo in a competitive and evolving environment. Learn more about what it means to work at Syneos Health.

    Additional Information:

    The tasks and responsibilities listed in this job description are not exhaustive. Syneos Health may assign additional duties at its discretion. Equivalent experience, skills, and/or education will be considered, and the company reserves the right to determine qualifications. This description aims to comply with all relevant employment legislation, including the EU Equality Directive and the Americans with Disabilities Act, which mandates reasonable accommodations when necessary.

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