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Cra Ii Madrid

2+ years
Not Disclosed
10 Sept. 27, 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 II

About Syneos Health

Syneos Health® is a leading integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We bring together clinical, medical affairs, and commercial insights to address the challenges of modern markets. Our Clinical Development model prioritizes the customer and patient, striving to simplify processes and enhance collaboration for better outcomes.

Why Syneos Health?

We are committed to developing our people through career progression, engaged management, technical training, and recognition programs. Our Total Self culture allows you to be authentically yourself, fostering a diverse environment where everyone feels a sense of belonging.

Job Responsibilities

  • Site Management: Conduct site qualification, initiation, interim monitoring, and close-out visits (on-site or remotely) to ensure compliance with regulatory standards, ICH-GCP guidelines, and study protocols. Assess site performance and communicate any serious issues to the project team, developing action plans as necessary.

  • Informed Consent: Verify that the informed consent process is performed and documented appropriately, safeguarding patient confidentiality and assessing safety and data integrity at sites.

  • Monitoring Activities: Execute tasks per the Clinical Monitoring/Site Management Plan, including:

    • Assessing site processes.
    • Reviewing source documents and medical records.
    • Ensuring data accuracy in case report forms (CRFs) and resolving queries effectively.
    • Complying with electronic data capture requirements.
  • Investigational Product Oversight: Manage investigational product inventory and verify compliance with protocols regarding dispensing, labeling, and security.

  • Investigator Site File Management: Regularly review the Investigator Site File (ISF) for accuracy and completeness, ensuring alignment with the Trial Master File (TMF).

  • Documentation: Maintain comprehensive documentation through confirmation letters, trip reports, and tracking systems to monitor project status and action items.

  • Project Coordination: Understand project scope, budgets, and timelines, managing site-level communications to achieve objectives. Adapt to changing priorities as needed.

  • Liaison Role: Serve as the primary contact with study site personnel, ensuring compliance and training for project-specific requirements.

  • Meetings and Training: Prepare for and attend Investigator Meetings, project staff meetings, and clinical training sessions as required.

  • Audit Readiness: Provide guidance for audit preparedness, ensuring compliance with relevant standards.

  • Real World Late Phase Responsibilities: For this phase, act as Site Management Associate II, supporting sites throughout the study lifecycle, conducting chart abstractions, and collaborating with local teams.

Qualifications

  • Bachelor’s degree or RN in a related field, or equivalent experience.
  • Strong knowledge of Good Clinical Practice/ICH Guidelines and applicable regulations.
  • Proficient computer skills and ability to embrace new technologies.
  • Excellent communication, presentation, and interpersonal skills.
  • Willingness to travel up to 75% regularly.

Join Us at Syneos Health

With a strong track record—working with 94% of all Novel FDA Approved Drugs and over 200 studies across 73,000 sites—we encourage you to challenge the status quo and take initiative in our dynamic environment.

Additional Information

This job description may not cover all tasks and responsibilities, as Syneos Health reserves the right to assign additional duties at its discretion. We are committed to compliance with all relevant employment laws, including reasonable accommodations for individuals with disabilities.

If you're ready to make a difference and grow with us, apply today!