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
Prior internship experience in regulatory affairs would be an added advantage!
Interested applicants, please email your updated CV to rachel.lim@recruitexpress.com.sg for more information.
We regret to inform that only shortlisted candidates will be contacted.
EA Personnel: Lim Ruo Yi, Rachel (R23116144)
Company EA license No.: Recruit Express Pte Ltd (99C4599)
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