Clinical Trial Operations Specialist

Recruit Express Pte Ltd; Singapore; On-site; SGD 55,000 - 75,000; Full time

Job summary

Recruit Express Pte Ltd is seeking a Clinical Research Associate to conduct pre-study activities, site initiation, routine monitoring and close-out visits in adherence to ICH-GCP, SOPs and regulatory requirements.

The role covers site feasibility assessments, investigator/site selection and recruitment support, liaison with PIs, sites, clients and institutional representatives, and management of study documents and regulatory reviews.

Qualifications

• Degree in Pharmacy related discipline.

Responsibilities

• Conduct pre-study, site initiation, routine monitoring and close-out visits in compliance with ICH-GCP, SOPs and regulatory requirements.
• Perform site feasibility assessments and support investigator/site selection and recruitment.
• Liaise with Principal Investigators (PIs), clinical trial sites, clients and institutional representatives.
• Negotiate study budgets and coordinate investigator meetings, client meetings and bid defence presentations.
• Collect, review and process regulatory, administrative and clinical trial documents.
• Review study protocols, Case Report Forms (CRFs) and clinical trial data to ensure accuracy and completeness.
• Monitor clinical trial sites to ensure proper data collection, source documentation and regulatory compliance.
• Prepare Serious Adverse Event (SAE) reports and study status reports.
• Manage study-related queries, issues, supplies and vendors, ensuring timely resolution of data discrepancies.

Education

Degree in Pharmacy related discipline

Job description

Recruit Express Pte Ltd is seeking a Clinical Research Associate to conduct pre-study activities, site initiation, routine monitoring and close-out visits in adherence to ICH-GCP, SOPs and regulatory requirements.

The role covers site feasibility assessments, investigator/site selection and recruitment support, liaison with PIs, sites, clients and institutional representatives, and management of study documents and regulatory reviews.