Clinical Research Associate

Job Summary:

Clinical Research Associate

Key Responsibilities:

• Monitor ongoing clinical trials to ensure compliance with study protocols, SOPs, and regulatory requirements.
• Conduct site visits, including initiation, monitoring, and close-out visits.
• Review case report forms (CRFs) and ensure accurate data collection.
• Assist in site selection, training, and performance evaluation of investigators.
• Identify, document, and communicate deviations, issues, and adverse events.
• Support regulatory submissions and maintain essential study documentation.
• Collaborate with cross-functional teams including clinical operations, data management, and medical affairs.
• Ensure patient safety and data integrity throughout the clinical trial process.

Required Skills & Qualifications:

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or related field.
• Knowledge of GCP, ICH guidelines, and clinical trial regulations.
• Strong understanding of clinical trial protocols and documentation standards.
• Excellent attention to detail, analytical skills, and problem-solving abilities.
• Proficiency in Microsoft Office and clinical trial management systems (CTMS).

Preferred Skills:

• Experience with electronic data capture (EDC) systems.
• Familiarity with pharmacovigilance and safety reporting.
• Certification in clinical research (e.g., ACRP, SOCRA) is a plus.
• Strong communication and interpersonal skills for interacting with site staff and investigators.