CRA I (Immediate Joiners)

Roles & Responsibilities:
• Conduct on-site and remote monitoring visits using a Risk-Based Monitoring (RBM) approach
• Perform Source Data Review (SDR), Source Data Verification (SDV), and CRF review to ensure data accuracy
• Ensure compliance with approved protocol, ICH-GCP guidelines, SOPs, and applicable regulations
• Perform investigational product accountability through inventory and documentation review
• Identify site process gaps, perform Root Cause Analysis (RCA), and implement corrective/preventive actions
• Prepare monitoring visit reports and follow up on findings until resolution
• Initiate, monitor, and close-out clinical trial sites as per regulatory requirements
• Ensure essential documents are complete, accurate, and audit-ready
• Maintain and update study systems such as CTMS
• Coordinate communication between investigational sites, sponsors, and internal teams
• Participate in investigator meetings and assist in site identification
• Support audits, inspections, and regulatory submissions
• Contribute to process improvement initiatives and project-related activities

Qualification:
• Bachelor’s degree in Life Sciences or related field
• OR Registered Nursing certification
• OR Equivalent academic/vocational qualification

Experience:
• Minimum ~2 years of clinical monitoring experience (or equivalent exposure in clinical trials/healthcare research environment)
• Experience in clinical trials, medical research, or healthcare settings preferred

Skills:
• Strong knowledge of ICH-GCP and regulatory requirements
• Understanding of medical terminology and therapeutic areas
• Risk-Based Monitoring (RBM) knowledge
• Strong critical thinking and problem-solving abilities
• Good organizational and time management skills
• Effective written and verbal communication skills (English proficiency)
• Proficiency in Microsoft Office and clinical trial systems
• Ability to work independently and collaboratively
• Willingness to travel frequently (60–80%)

About the Organization:
The organization is a global clinical research partner supporting leading pharmaceutical and biotechnology companies across 100+ countries. It has contributed to thousands of clinical trials in recent years, focusing on high-quality monitoring, regulatory compliance, and innovative clinical development solutions.