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Senior Cra Ukraine

2+ years
Not Disclosed
10 Dec. 18, 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 Title: Senior Clinical Research Associate (CRA)
Location: Ukraine – Kyiv
Job ID: 24006655
Updated: December 16, 2024

Job Description:

Syneos Health is seeking an experienced Senior Clinical Research Associate (CRA) to join our team in Ukraine. This role offers an exciting opportunity to manage clinical monitoring and site management, ensuring compliance with regulatory standards, ICH-GCP guidelines, and study protocols. As a Senior CRA, you will be responsible for site qualification, monitoring visits, site management, and close-out activities, both on-site and remotely, and ensuring data integrity and patient safety throughout the clinical trial process.

Key Responsibilities:

  • Perform site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remotely).
  • Ensure regulatory, ICH-GCP, and protocol compliance at each site.
  • Monitor the informed consent process and ensure patient confidentiality and safety.
  • Review source documents, medical records, and clinical data for accuracy and completeness.
  • Resolve queries and guide site staff to ensure data quality and protocol adherence.
  • Monitor investigational product (IP) handling, storage, and administration according to protocol.
  • Maintain the Investigator Site File (ISF) and ensure timely and accurate documentation in the Trial Master File (TMF).
  • Support patient recruitment and retention strategies, ensuring project milestones are met.
  • Train and mentor junior CRAs and assist in their development.
  • Act as a liaison with project site personnel and support audit readiness.
  • Participate in global clinical monitoring staff meetings and investigator meetings.

Qualifications:

  • Bachelor’s degree or RN in a related field, or equivalent combination of education and experience.
  • Previous clinical monitoring experience in Ukraine.
  • Strong knowledge of ICH-GCP Guidelines and other regulatory requirements.
  • Proficient in computer skills and the use of clinical trial technologies.
  • Excellent communication, presentation, and interpersonal skills.
  • Fluency in Ukrainian and proficiency in English.
  • Ability to manage required travel for monitoring visits.