Clinical Trial/Project Assistant #HRY

RECRUIT EXPRESS PTE LTD; Singapore; On-site; SGD 45,000 - 65,000; Full time

Job summary

RECRUIT EXPRESS PTE LTD is seeking a Clinical Research Associate to conduct pre-study activities, site initiation visits, routine monitoring and close-out visits in line with ICH‑GCP and ClinActis SOPs.

You will coordinate with Principal Investigators, assist with site feasibility and investigator/site selection, review CRFs and regulatory documents, manage data queries and prepare study status reports for clients and internal management.

Qualifications

• Min 1 year clinical research experience.
• Familiarity with ICH-GCP and SOPs (ClinActis) is preferred.

Responsibilities

• Conduct pre-study, site initiation, routine monitoring and close-out visits in accordance with ICH-GCP and ClinActis SOPs.
• 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

Skills

Clinical research

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