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    Cra Ii- Scra (Melbourne/ Sydney/ Brisbane))

    Syneos Health
    1+ years
    Not Disclosed
    Remote, USA
    10 Aug. 5, 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, 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

    Join Our Team as an Experienced Clinical Research Associate in Denmark!

    At Syneos Health®, we are a top-tier, fully integrated biopharmaceutical solutions organization committed to accelerating customer success. Our mission is to transform clinical, medical affairs, and commercial insights into actionable outcomes that address today’s market challenges.

    Our Clinical Development model is designed with the customer and patient at its core. We constantly seek to simplify and streamline our processes to ensure Syneos Health is not only easier to work with but also a great place to work.

    Whether you join us through a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers. Together, we innovate to help our customers achieve their goals, driven by our shared passion to change lives.

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

    Why Syneos Health?

    • Career Development: We are passionate about nurturing our people through career development and progression.
    • Supportive Management: Enjoy supportive and engaged line management.
    • Training & Recognition: Benefit from technical and therapeutic area training, peer recognition, and a total rewards program.
    • Inclusive Culture: Our Total Self culture allows you to be authentically yourself, uniting us globally in our dedication to taking care of our people.
    • Diversity & Belonging: We believe in creating a place where everyone feels they belong by embracing diversity of thoughts, backgrounds, cultures, and perspectives.

    Job Responsibilities

    • Conduct site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely) ensuring compliance with regulatory, ICH-GCP, GPP, and protocol requirements.
    • Evaluate overall site performance, provide recommendations, and escalate serious issues to the project team.
    • Ensure informed consent processes are performed and documented appropriately.
    • Protect the confidentiality of each subject/patient and assess factors affecting their safety and clinical data integrity.
    • Execute Clinical Monitoring/Site Management Plans:
      • Assess site processes
      • Review site source documents and medical records
      • Verify accuracy and completeness of clinical data in case report forms
      • Apply query resolution techniques and guide site staff as needed
      • Ensure site compliance with electronic data capture requirements
    • Perform investigational product (IP) inventory, reconciliation, and review storage and security.
    • Review and reconcile the Investigator Site File (ISF) with the Trial Master File (TMF).
    • Document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents.
    • Support subject/patient recruitment, retention, and awareness strategies.
    • Manage site-level activities and communications to meet project objectives, deliverables, and timelines.
    • Act as the primary liaison with study site personnel or collaborate with Central Monitoring Associates.
    • Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings.
    • Provide guidance towards audit readiness standards and support preparation for audit follow-up actions.
    • Provide direct supervision, training, and mentorship to junior CRA staff.
    • May be mentored and assigned lead tasks under the supervision 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.
    • Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements.
    • Previous monitoring experience in Denmark.
    • Proficient in new technologies and good computer skills.
    • Excellent communication, presentation, and interpersonal skills.
    • Moderate level of critical thinking skills.
    • Fluency in Danish and proficiency in English.
    • Ability to manage required travel regularly throughout Denmark and occasionally in the wider Nordics region.

    About Syneos Health

    Over the past 5 years, we have contributed to 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 Studies across 73,000 Sites involving 675,000+ Trial patients. No matter your role, you'll challenge the status quo with us in a competitive and ever-changing environment.

    Additional Information: Tasks, duties, and responsibilities listed are not exhaustive. The Company may assign other tasks and responsibilities as needed. Equivalent experience, skills, and education will be considered. This job description does not create an employment contract. The Company complies with all obligations imposed by country-specific legislation, including the EU Equality Directive. We are committed to the Americans with Disabilities Act and will provide reasonable accommodations when appropriate.

    Apply for this job or Join our Talent Network to stay connected to additional career opportunities.

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