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Cra I - Paris - Study Coordinator Or Cra Intern Experience

2+ years
Not Disclosed
10 Dec. 6, 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, 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

Job Opportunity: Clinical Research Associate I

Company: Syneos Health
Position: Clinical Research Associate I
Location: Remote/Travel-Based Role
Experience: Entry-Level Role


About Syneos Health

Syneos Health is a globally integrated biopharmaceutical solutions organization, driving innovation and excellence in clinical, medical, and commercial services. With a strong commitment to simplifying processes and placing patients and customers at the center, Syneos Health is shaping the future of biopharmaceutical advancements.


Why Join Syneos Health?

  • Passionate career development with supportive management and structured training programs.
  • Emphasis on a Total Self Culture that celebrates authenticity and diversity.
  • Continuous innovation and a collaborative work environment to foster personal and professional growth.

Job Responsibilities

As a Clinical Research Associate I, you will:

  • Perform site qualification, initiation, monitoring, and close-out visits.
  • Ensure compliance with ICH-GCP guidelines, regulations, and protocols.
  • Verify informed consent processes, protect patient confidentiality, and assess clinical data integrity.
  • Conduct data review, query resolution, and ensure EDC (Electronic Data Capture) compliance.
  • Handle investigational product (IP) management, including inventory and reconciliation.
  • Review, reconcile, and archive clinical study documents (ISF, TMF).
  • Track site-level activities, manage communications, and adapt to changing project priorities.
  • Provide audit readiness support and facilitate training for project-specific team members.

For Real-World Late Phase Studies, additional responsibilities include:

  • Supporting site operations through the study lifecycle.
  • Engaging in chart abstraction and data collection.
  • Collaborating with sponsor affiliates and local medical staff.

Qualifications

  • Bachelor’s degree or RN in a related field (or equivalent education/training).
  • Strong understanding of Good Clinical Practice/ICH Guidelines and regulatory requirements.
  • Excellent computer skills and adaptability to new technologies.
  • Effective communication, presentation, and interpersonal skills.
  • Willingness to travel up to 75% regularly.

About Syneos Health's Impact

  • Partnered with 94% of all FDA-approved novel drugs over the past 5 years.
  • Engaged in over 200 studies across 73,000 sites, involving 675,000+ trial patients.

Additional Information

This role includes tasks that may evolve based on company discretion and project needs. Syneos Health is committed to providing reasonable accommodations to support employees or applicants with disabilities.