MSD CRA 

Taiwan, Taipei 

424854846

Job Description

• Develops strong site relationships and ensures continuity of site relationships through all
phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP,
Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated
documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve
Site Ready.
• Participates & provides inputs on site selection and validation activities.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure:
o Data generated at site are complete, accurate and unbiased.
o Subjects’ right, safety and well-being are protected.
• Conducts site visits including but not limited to validation visits, initiation visits, monitoring
visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact
reports appropriately in a timely manner.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study
maintenance and study close-out.
• Communicates with Investigators and site staff on issues related to protocol conduct,
recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections
and overall site performance.
• Identifies, assesses and resolves site performance, quality or compliance problems andManager, CRM, TA Head and CRD as needed.
• Works in partnership with GCTO country operations, finance, regulatory affairs,
pharmacovigilance, legal and regional operations, HQ functional areas and externally with
vendors and IRB/IECs and Regulatory Authorities in support of assigned sites.
• Manages and maintains information and documentation in CTMS, eTMF and various other
systems as appropriate and per timelines.
• Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME),
buddy/mentor and sharing best practices as appropriate/required.
• Supports and/or leads audit/inspection activities as needed.
• Performs co-monitoring visits where appropriate.
• Following the country strategy defined by CRD and/or CRA manager, contributes to the
identification of new potential sites and works closely with them to develop strong clinical
research capabilities.

Current Contingent Workers apply

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