Clinical Project Admin Assistant (Biotech) #HRY

Recruit Express Pte Ltd; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Recruit Express Pte Ltd in Singapore is seeking a Clinical Research Associate to conduct pre-study, site initiation, routine monitoring and close-out visits in accordance with ICH-GCP and ClinActis SOPs.

You will coordinate investigator sites, recruit and communicate with Principal Investigators, review protocols and CRFs, negotiate study budgets, and prepare SAE reports and study status updates for clients and internal management.

Qualifications

• Knowledge of ICH-GCP guidelines and clinical trial procedures.
• Experience coordinating site initiation and monitoring visits.
• Familiarity with regulatory and administrative documents for trials.

Responsibilities

• Perform pre-study, site initiation, routine monitoring and close-out visits.
• Conduct feasibility assessments and assist with investigator/site selection.
• Recruit and communicate with Principal Investigators and sites.
• Negotiate study budgets with investigators and institutions.
• Collect, review and process regulatory and administrative documents.
• Review protocols and CRFs.
• Coordinate and present at Investigator Meetings.
• Prepare SAE reports and project status updates for clients and management.
• Manage study-related requests, queries and third-party vendors.
• Verify CRFs and resolve data queries with site personnel.
• Review tables and listings generated from study data.
• Conduct on-site monitoring to ensure data collection and regulatory compliance.
• Ensure sites operate according to regulations and quality standards.

Skills

ICH-GCP knowledge

Regulatory understanding

Site coordination communication

Education

Degree in Pharmacy related discipline

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

Degree in Pharmacy related discipline