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Cra Ii - Sponsor Dedicated - Bulgaria (Homebased)

2+ years
Not Disclosed
10 Dec. 5, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Here is a concise summary of the Clinical Research Associate II position at Syneos Health:


About Syneos Health

Syneos Health is a global biopharmaceutical solutions company dedicated to accelerating customer success through integrated clinical, medical affairs, and commercial services. The organization emphasizes collaboration, innovation, and inclusivity to improve therapeutic outcomes.


Role Overview

The Clinical Research Associate II (CRA II) manages clinical site activities, including monitoring, compliance, and patient safety, for biopharmaceutical studies. The role involves ensuring adherence to ICH-GCP guidelines, regulatory standards, and protocols, with a strong focus on site-level communication and data integrity.


Key Responsibilities

  • Monitoring and Site Management: Conducts site qualification, initiation, monitoring, and close-out visits. Evaluates site performance, resolves issues, and ensures protocol compliance.
  • Data Verification and Integrity: Reviews source documents, case report forms (CRFs), and ensures accurate data capture.
  • Regulatory Compliance: Maintains adherence to GCP, ICH, and sponsor SOPs. Verifies investigational product (IP) handling and documentation.
  • Documentation: Prepares confirmation letters, follow-up letters, trip reports, and communication logs. Maintains detailed records in tracking systems.
  • Collaboration: Acts as a liaison with site staff, sponsor teams, and regulatory bodies. Participates in investigator and sponsor meetings.
  • Real-World Late Phase (RWLP): Supports study lifecycles, develops local informed consent forms, and ensures compliance with country-specific requirements.

Qualifications

  • Education: Bachelor’s degree or RN equivalent in a related field.
  • Experience: Proficiency in GCP/ICH guidelines and clinical monitoring.
  • Skills: Strong communication, presentation, and interpersonal skills. Technological aptitude and adaptability.
  • Travel Requirement: Willingness to travel up to 75%.

Why Join Syneos Health?

  • Development Opportunities: Comprehensive training, mentorship, and career progression pathways.
  • Inclusive Culture: Commitment to diversity and fostering a supportive work environment.
  • Industry Leadership: Partnering with 94% of FDA-approved drugs over the past five years, providing opportunities to contribute to cutting-edge therapies.

Additional Information

The role may include tasks outside the listed description to meet project needs. Syneos Health is an equal opportunity employer and provides reasonable accommodations as per ADA requirements.

For more information about Syneos Health and its mission, visit their careers page or contact their team directly.