Instagram
youtube
Facebook

Freelance Cra Georgia (Europe)

0-2 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: Freelance CRA (Clinical Research Associate)
Location: Home-Based (Georgia, Europe)
Job ID: 24006872
Closing Date: Ongoing

Job Description:

Syneos Health is seeking a Freelance Clinical Research Associate (CRA) for monitoring and site management activities across Phase I-IV clinical research projects. The role involves conducting on-site or remote visits to ensure compliance with protocol, regulatory guidelines, and ICH-GCP standards. You will also be responsible for managing site performance, ensuring subject safety, resolving data discrepancies, and maintaining accurate documentation. This is an exciting opportunity for an experienced CRA to take ownership of clinical projects and collaborate with cross-functional teams.

Key Responsibilities:

  • Perform site qualification, initiation, monitoring, and close-out visits (on-site or remote).
  • Ensure compliance with protocol, GCP, and regulatory requirements.
  • Review and verify informed consent processes and subject safety.
  • Conduct source document review and ensure accurate data entry in case report forms (CRF).
  • Manage investigational product (IP) inventory and ensure correct dispensation.
  • Ensure investigator site files (ISF) are accurate and complete, reconciling with trial master files (TMF).
  • Manage site-level activities, ensuring timely and efficient project delivery.
  • Participate in investigator meetings, sponsor meetings, and support audit preparations.

Qualifications:

  • Previous experience as a Clinical Research Associate (CRA) in clinical research.
  • Strong knowledge of ICH-GCP guidelines and regulatory requirements.
  • Ability to manage multiple tasks and adapt to changing priorities.
  • Experience with site management and monitoring across various phases of clinical trials.
  • Strong communication, organizational, and problem-solving skills.