Senior Clinical Research Coordinator
Pharmaceutical Research Unit
Total years of experience :4 years, 5 Months
• Lead the team of Clinical Research Coordinators.
• Oversee the conduct of clinical studies and ensure compliance with guidelines and protocols.
• Review the status and contents of essential documents throughout all stages of clinical conduct, ensuring that all
regulatory requirements and internal SOP instructions are met.
• Train clinical department staff on clinical research principles, e.g., GCP.
• Prepare daily, weekly, and monthly reports pertaining to the progress of clinical studies.
• In-charge of the Clinical Data Review Project in PRU, which pertains to all clinical study documents starting at protocol writing and initiation, up until the issuance of the Clinical Study Report.
• Assist in implementing and upgrading the quality management system including issuance and strengthening of
standard operating procedures (SOPs) and quality system parameters, i.e., risk assessment, root cause
analysis, and quality deviations
• Conduct periodic facility, documentation, and in-process compliance audits and interpret reports with various
departments and make sure findings are recorded and followed-up so that issues can be rectified
• Audit study protocols and final study reports prior to their submission to sponsors and regulatory authorities
and follow-up on the progress of amendment issuance and protocol approvals
• Assure implementation and compliance with international guidelines and internal standard operating
procedures throughout all activities performed and documents submitted
• Perform external inspections of contractors and facilities
• Investigate irregularities and non-compliance issues, and follow-up on the outcomes of investigations
• Contribute to robust and effective compliance controls within the organization
• Collaborate with other departments to develop and maintain constructive and cooperative working
relationships with staff and outside entities
• Follow-up audit findings with external auditors and inspectors
• Work with management to investigate areas of concern, and implement proper corrective and preventative
actions
• Generate monthly and quarterly quality reports to determine workload management
• Query assistance and investigation
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