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Cra Ii Madrid

3-4 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 transform unique clinical, medical affairs, and commercial insights into impactful outcomes that address the complexities of modern markets. Our Clinical Development model centers around both the customer and the patient, driving us to continually simplify and enhance our operations.

Why Syneos Health?

We are passionate about nurturing our talent through career development, supportive management, technical training, and peer recognition. Our Total Self culture promotes authenticity, creating an inclusive environment where everyone can thrive. By embracing diverse perspectives, we build a workplace where everyone feels they belong.

Key Responsibilities

  • Site Management: Conduct site qualification, initiation, interim monitoring, and close-out visits (both on-site and remotely) to ensure compliance with regulatory standards, ICH-GCP guidelines, and study protocols. Use sound judgment to evaluate site performance and escalate serious issues to the project team as needed.

  • Informed Consent Oversight: Verify that the informed consent process is thoroughly executed and documented, ensuring patient confidentiality and evaluating factors impacting safety and data integrity.

  • Monitoring Tasks: Execute responsibilities per the Clinical Monitoring/Site Management Plan, including:

    • Assessing site processes.
    • Conducting source document reviews and verifying the accuracy of clinical data in case report forms (CRFs).
    • Implementing query resolution techniques and guiding site staff to close outstanding issues.
    • Ensuring compliance with electronic data capture requirements.
  • Investigational Product Management: Oversee investigational product inventory and ensure compliance with protocol for dispensing, labeling, and security.

  • Documentation Management: Maintain accurate records of activities, including confirmation letters, trip reports, and tracking system data to monitor project status.

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

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

  • Meeting Participation: Prepare for and attend Investigator Meetings and project staff meetings, engaging in relevant clinical training sessions.

  • Audit Readiness: Provide guidance on audit preparedness and ensure compliance with applicable standards.

  • Real World Late Phase Responsibilities: When acting as Site Management Associate II, support sites throughout the study lifecycle, conduct chart abstractions, and collaborate with local teams. May also train junior staff and suggest potential study sites based on local insights.

Qualifications

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

Get to Know Syneos Health

In the past five years, we have partnered on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products, working on over 200 studies across 73,000 sites with over 675,000 trial patients. Join us in challenging the status quo in a dynamic and competitive environment.

Additional Information

This job description is not exhaustive and may be subject to change at the company’s discretion. Equivalent experience, skills, and education will also be considered. Syneos Health is committed to compliance with all applicable employment laws, including providing reasonable accommodations for individuals with disabilities.