Job Title: Clinical Research Associate - Clinical Trial
Ahmedabad, India
ORGANISATIONAL OVERVIEW
Lambda Therapeutic Research is a leading Global Clinical Research Organization (CRO), headquartered in Ahmedabad, India, with operations across Mehsana (India), Las Vegas (USA), Toronto (Canada), London (UK), Barcelona (Spain), and Warsaw (Poland).
At Lambda, a team of 1,200+ highly skilled professionals and advanced digital platforms to ensure precision and efficiency in every project. By prioritizing secure IT infrastructure, automation, and data integrity, Lambda ensures timely project delivery while meeting stringent global regulatory standards. Lambda’s reputation for compliance and quality is backed by an exceptional regulatory track record. Over the past five years, Lambda has successfully completed 60+ international inspections and audits by leading authorities, including USFDA, EMA, MHRA, EU member states, and other global regulatory bodies. This achievement showcases Lambda’s unwavering commitment to global clinical research excellence, consistently meeting and exceeding international regulatory standards.
JOB DETAILS
Role of a Clinical Research Associate (CRA)
A CRA ensures the smooth conduct of clinical trials by acting as a key link between the sponsor and investigational sites. The role involves:
- Site Management: Conduct site visits (selection, initiation, monitoring, and close-out) to ensure compliance with study protocols and regulatory requirements.
- Regulatory & Protocol Compliance: Ensure adherence to GCP, SOPs, and local regulations; verify informed consent and patient safety.
- Training & Communication: Train investigators and site staff on study protocols and regulatory guidelines; maintain timely communication with sites and sponsors.
- Data & Documentation: Review CRFs/eCRFs for accuracy, verify source data, reconcile discrepancies, and maintain Site Master File.
- Reporting: Prepare monitoring visit reports and follow-up letters promptly.
- Investigational Product Oversight: Monitor drug accountability and coordinate trial material distribution.
- Quality Assurance: Ensure equipment calibration, proper documentation, and timely archival of study records.
EXPERIENCE
Total Experience: 5 years in Clinical Research, preferably in Clinical Trials.
Specialization: Minimum 1 year as a Clinical Research Associate (CRA).
Expertise: Clinical trial management, regulatory compliance, site monitoring, and documentation.
EDUCATIONAL QUALIFICATION
- Bachelor’s degree (e.g., B.Pharm, M.Pharm, M.Sc.) or equivalent in life sciences.
COMPETENCIES