We are seeking a detail-oriented and motivated Clinical Research Associate (CRA) to oversee and monitor clinical trials while ensuring compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements. The ideal candidate will have experience in site monitoring, clinical trial management, and maintaining high-quality clinical data.
Key Responsibilities
- Monitor clinical trial sites to ensure compliance with study protocols, ICH-GCP, SOPs, and applicable regulatory guidelines.
- Conduct Site Initiation Visits (SIV), Site Monitoring Visits (SMV), and Close-Out Visits (COV).
- Verify source data and ensure data accuracy, integrity, and completeness.
- Maintain Trial Master File (TMF) and essential study documentation.
- Build and maintain strong relationships with investigators and site staff.
- Identify, document, and resolve protocol deviations and study-related issues.
- Ensure timely reporting of adverse events (AEs) and serious adverse events (SAEs).
- Review informed consent documentation and ensure participant safety.
- Prepare monitoring visit reports and follow-up letters.
- Coordinate with Clinical Operations, Data Management, Biostatistics, Medical Writing, and Regulatory teams.
- Support study start-up, patient recruitment, and site management activities.
- Ensure studies are completed within timelines and quality standards.
Required Qualifications
- Bachelor's or Master's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, or a related field.
- 2–6 years of experience as a Clinical Research Associate in clinical trials.
- Strong knowledge of ICH-GCP, FDA, EMA, and local regulatory requirements.
- Experience with EDC systems, CTMS, and eTMF platforms.
- Excellent communication, documentation, and organizational skills.
- Willingness to travel for site monitoring visits.
Preferred Skills
- Clinical site monitoring experience across multiple therapeutic areas.
- Knowledge of protocol review, source document verification (SDV), and risk-based monitoring.
- Strong analytical and problem-solving abilities.
- Ability to manage multiple studies simultaneously and work independently.
Benefits
- Competitive salary and performance incentives.
- Health insurance and employee wellness programs.
- Learning and career development opportunities.
- Collaborative and supportive work environment.
Company Description
NexPro Technologies offers robust, responsive and value-driven IT consulting and placement services.