Clinical Research Associate (Biotech) #HRY

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 48,000 - 78,000; Full time

Job summary

RECRUIT EXPRESS PTE LTD in Singapore is seeking an experienced Clinical Research Monitor to oversee site activities in accordance with ICH-GCP and SOPs. You will conduct pre-study visits, site initiation, routine monitoring and data verification to ensure study quality.

The role involves coordinating with Principal Investigators and sites, negotiating budgets, reviewing CRFs and SAE reports, and preparing status updates for clients while maintaining regulatory compliance across sites.

Qualifications

• Min 1 year clinical research experience.
• Experience with ICH-GCP and SOPs.
• Ability to coordinate with investigators and sites.

Responsibilities

• Conduct pre-study, site initiation, routine monitoring and close-out visits per ICH-GCP and SOPs.
• Recruit and communicate with Principal Investigators (PIs) and investigator sites.
• Negotiate study budgets with investigators and institution representatives.
• Collect, review and process regulatory and administrative documents from trial sites.
• Review clinical trial protocols and CRFs; verify data and resolve data queries.
• Coordinate and present at Investigator Meetings and client meetings.

Skills

Clinical research

GCP compliance

Site monitoring

Budget negotiation

Regulatory documentation

Job description

Job Scope

• Conduct pre-study, site initiation, routine monitoring and close-out visits in accordance with ICH-GCP, ClinActis SOPs and client requirements.
• Conduct site feasibility assessments and assist with investigator/site selection.
• Recruit and communicate with Principal Investigators (PIs) and investigator sites .
• Negotiate study budgets with investigators and institution representatives.
• Collect, review and process regulatory and administrative documents from clinical trial sites.
• Review clinical trial protocols and Case Report Forms (CRFs) .
• Coordinate and present at Investigator Meetings .
• Participate in client meetings and bid defence meetings .
• Prepare and review Serious Adverse Event (SAE) reports .
• Prepare project/study status reports for clients and internal management.
• Manage study-related requests, queries and issues, including study supplies and third-party vendors .
• Verify completed CRFs and review clinical trial data.
• Resolve data queries with clinical trial site personnel.
• Review tables and listings generated from study data.
• Conduct on-site monitoring to oversee data collection, source documentation, CRFs and regulatory compliance .
• Ensure clinical trial sites are operating according to applicable regulations, protocols and quality standards

Requirement

• Min 1 year clinical research experience