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Cra Belgium - Single Sponsor

0-5 years
Not Disclosed
15 June 10, 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

Position: Clinical Research Associate

Location: Belgium

Employment Type: Full-time

About Syneos Health: Syneos Health® is a fully integrated biopharmaceutical solutions organization committed to accelerating customer success. With a focus on bringing the customer and the patient to the center of everything, Syneos Health translates clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Whether through Functional Service Provider partnerships or Full-Service environments, Syneos Health collaborates with passionate problem solvers to accelerate the delivery of therapies and change lives.

Why Syneos Health:

  • Career development and progression opportunities
  • Supportive and engaged line management
  • Technical and therapeutic area training
  • Peer recognition and total rewards program
  • Total Self culture fostering authenticity and belonging

Responsibilities:

  1. Perform site qualification, initiation, monitoring, and close-out visits, ensuring regulatory and protocol compliance.
  2. Verify the process of obtaining informed consent and protect subject/patient confidentiality.
  3. Assess factors affecting subject/patient safety and data integrity.
  4. Conduct source document review, verify clinical data accuracy, and resolve queries.
  5. Perform investigational product inventory and reconciliation.
  6. Maintain Investigator Site File and Trial Master File accuracy and completeness.
  7. Document activities and support subject/patient recruitment and retention.
  8. Manage site-level activities and communication to meet project objectives and timelines.
  9. Act as the primary liaison with study site personnel and participate in clinical training sessions.
  10. Provide guidance towards audit readiness standards and support audit preparation.
  11. Maintain knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs.

Qualifications:

  • Bachelor’s degree or RN in a related field or equivalent experience
  • Previous monitoring experience in Belgium
  • Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
  • Strong computer skills and ability to embrace new technologies
  • Excellent communication skills in Dutch, French, and English
  • Ability to travel for monitoring visits

Additional Information: Tasks, duties, and responsibilities are not exhaustive and may vary. The Company may assign other tasks as needed. Equivalent experience, skills, and education will also be considered. The Company is committed to compliance with relevant legislation and providing reasonable accommodations when appropriate.

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At Syneos Health, diversity and inclusion are core values. Candidates are encouraged to apply even if their past experience does not align perfectly, as transferrable skills are considered. Join our Talent Network for additional career opportunities.