About the role
AI summarisedJoin our global team supporting top pharmaceutical companies and biotechs across various clinical trials. As a Clinical Research Associate, you will conduct monitoring activities to ensure trial compliance with protocol, regulatory guidelines, and ICH-GCP standards while maintaining strong relationships with investigational sites.
Life SciencesOnsite
Key Responsibilities
- Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis to address process failures and implement corrective/preventive actions.
- Ensure data accuracy through Source Data Review (SDR), Source Document Verification (SDV), and Case Report Form (CRF) review during on-site and remote monitoring.
- Assess investigational product through physical inventory checks and record reviews.
- Document observations in reports and letters adhering to approved business writing standards, escalating deficiencies promptly to clinical management.
- Maintain regular contact with investigative sites between visits to confirm protocol adherence, resolution of issues, and timely data recording.
- Conduct monitoring tasks strictly in accordance with the approved monitoring plan.
Requirements
- Knowledge of ICH-GCP guidelines and applicable regulations.
- Basic medical/therapeutic area knowledge and understanding of medical terminology.
- Strong oral and written communication skills for effective interaction with medical personnel.
- Ability to apply critical thinking, including in-depth investigation and problem-solving.
- Proficiency in managing Risk Based Monitoring concepts and processes.
- Good organizational, time management, and attention to detail skills.
- Ability to work effectively both independently and as part of a team.
- Solid computer skills, including Microsoft Office proficiency.