Note: The job is a remote job and is open to candidates in USA. Virtue America is seeking a Clinical Research Coordinator to support clinical research activities in pharmaceutical, biotechnology, or life sciences settings. The role assists with clinical study coordination, documentation, patient and site activities, data collection, and compliance with GCP, FDA requirements, and study protocols.
Responsibilities
- Coordinate day-to-day activities for clinical research studies and clinical trials
- Support study start-up, site activation, and ongoing study activities
- Maintain clinical trial documentation, study files, and essential documents
- Assist with patient recruitment, screening, scheduling, and follow-up activities
- Collect, review, and maintain accurate clinical study data
- Enter and update information in EDC/CTMS systems
- Support preparation for monitoring visits, audits, and regulatory inspections
- Ensure study activities follow protocols, SOPs, ICH-GCP , and applicable FDA requirements
- Identify and document protocol deviations, issues, and data discrepancies
- Collaborate with Clinical Operations, Data Management, Safety, Quality, and Regulatory teams
- Assist with informed consent documentation and study-related records
- Prepare study reports, tracking logs, and other clinical documentation
Skills
- Bachelor's degree in Life Sciences, Clinical Research, Pharmacy, Biology, Biotechnology, Nursing, Public Health , or a related field
- 0–3 years of experience in clinical research, clinical trials, healthcare, or pharmaceutical/life sciences environments
- Understanding of ICH-GCP, FDA regulations, and clinical trial processes
- Strong documentation, organizational, and communication skills
- Ability to work with clinical databases and Microsoft Office applications
- Experience with EDC, CTMS, eTMF, or other clinical trial systems
- Knowledge of clinical trial phases and study documentation
- Exposure to SOPs, protocol deviations, CAPA, and audit readiness
- Clinical research internship or academic project experience
Benefits
- Remote work
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