CLINICAL RESEARCH ASSOCIATE - [E711]

Tigermed Group


This position is responsible for project management and study site management from site selection to initiation, monitoring, and close-out of assigned clinical studies in accordance with Tigermed sponsor Standard Operating Procedures (SOPs), International Conference on Harmonization Good Clinical Practice (ICH-GCP), Clinical Practice standards (GCP), and other applicable regulations. The role ensures that all data generated by the sites is of high quality, collected on time, and within budget. Responsibilities: 1. Study site selection, initiation (SIV), and clinical monitoring; 2. Provide ongoing training to site staff regarding ICH-GCP, GCP, study protocol, and requirements; 3. Conduct site initiation to ensure thorough understanding of the study protocol and requirements; 4. Ensure timely collection and proper documentation of essential documents during study start-up, conduct, and close-down, maintaining investigator files and trial master files; 5. Prepare and archive study records according to protocol and sponsor requirements; 6. Disseminate safety information to all sites following SOPs and regulations; 7. Report Serious Adverse Events (SAEs) within the specified timelines in compliance with SOPs and regulations; 8. Finalize budget and obtain signed contracts prior to site initiation; 9. Ensure execution of Study Payment Schedule and retain relevant documentation; 10. Update and maintain study tools and systems promptly. Qualifications: - Bachelor's degree or higher in Medical, Pharmacology, Biology, or related fields; - Good understanding of GCP and clinical trial operations; - 1-2 years of Clinical Research Associate (CRA) experience; - Proficiency in written and spoken English; - Skills in Microsoft Word, Excel, PowerPoint, Outlook, etc.; - Strong communication and information-gathering skills; knowledge or experience in medical practice is a plus. We welcome passionate and creative individuals! We look forward to receiving your CV. Seniority level - Entry level Employment type - Full-time Job function - Research and Project Management Industries - Pharmaceutical Manufacturing and Research Services Referrals increase your chances of interviewing at Tigermed by 2x. Set job alerts for “Clinical Research Associate” roles. Location: Bogotá, D.C., Capital District, Colombia #J-18808-Ljbffr Required Skill Profession Investigación, Desarrollo Y Laboratorios

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