Job Description

Clinical Research Coordinator

We are seeking a Clinical Research Coordinator. The ideal candidate will have at least 1 year of clinical research experience , hold current IATA and GCP certifications , and be proficient in phlebotomy .

Responsibilities:

• Recruit, screen, and enroll participants for the clinical study.
• Obtain and document informed consent in compliance with ICH-GCP and institutional requirements.
• Conduct study visits and perform protocol-specific assessments, ensuring accurate and timely documentation in source according to ALCOA-CC principles.
• Perform phlebotomy, process, and ship blood and urine specimens in accordance with study protocols and IATA shipping regulations .
• Accurately enter source data into electronic data capture (EDC) systems (e.g., Medidata RAVE ) and resolve data queries promptly.
• Conduct study-related procedures, including vital signs, ECGs, and other required assessments.
• Record, report, and follow up on adverse events (AEs) and serious adverse events (SAEs) per sponsor and regulatory guidance.
• Manage investigational product (IP) accountability, including dispensing, collection, temperature monitoring, and IRT system documentation.
• Coordinate and prepare for sponsor and CRO visits, including qualification, site initiation, monitoring, and close-out visits.

Qualifications:

• Minimum 1 year of clinical research experience .

• Current IATA and GCP certifications required.

• Phlebotomy experience required.

• Strong understanding of ICH-GCP guidelines and regulatory documentation standards.

• Excellent attention to detail, organization, and communication skills.

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