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MSG
BeiGene
Clinical Research Associate
Full-Time
Seoul, South Korea
Clinical Research
Health & Biotech
06 October 2023
Description
- Conducts monitoring (pre study, initiation, routine monitoring and closeout visit), if require
- Conducts co monitoring visits, if required
- Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
- Attends onboarding--, disease indication and project specific training and general CRA training as required
- Documents monitoring activities appropriately following ICH GCP and BeiGene standards
- Conducts Quality Oversight Visits (QOV), as requested
- Completes monitoring visit/ QOV reports timely
- Assists with investigator/site identification
- Assists site to prepare Ethics Committee submissions
- Facilitates clinical trial site contract and budget negotiation
- Manages site queries and communications
- Assists in managing clinical trials, if required
- Establishes regular lines of communication with sites and COMs
- Provides protocol and related study training to assigned sites
- Evaluates the quality and integrity of site practices escalating quality issues as appropriate
- Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
- Collaborates with CRA Group / CRM to ensure recruitment plans and execute contingency plans, as needed
- Performs additional task as assigned
Qualifications
- Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical
- Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
- 1-3 years or more (SCRA) monitoring experience in the pharmaceutical or CRO industry
- Excellent communication and interpersonal skills
- Excellent organizational skills and ability to prioritize and multi-task
- Fluent in English (writing and speaking)
Apply
