Clinical Research Associate

1 week ago

India CareerUS Solutions Full time

Job Description Job Summary: We are seeking a detail-oriented Clinical Research Associate to monitor clinical trials, ensure compliance with regulatory standards, and support the timely execution of study protocols. The ideal candidate will work closely with clinical sites, investigators, and internal teams to ensure high-quality data collection and adherence to Good Clinical Practice (GCP). 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.

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