(Senior) Clinical Research Associate
1개월전에
Job Description:
About the Company:
BeiGene (NASDAQ: BGNE; HKEX: 06160; SHA: 688235) is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical trial candidates, we are committed to expediting the development of our diverse pipeline of novel therapies through collaborations or our own internal capabilities, with the aspirational goal of radically improving access to medicines for billions more people by 2030. BeiGene is a headquarter-less company by design, with a growing global team of approximately 8,000 colleagues across five continents. Job 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
Qualification Required:
• 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)
What we offer to our valued employees:
Market competitive compensation package including performance-based annual bonus scheme Company shares (generous welcome grant and performance-based annual equity plan) Full-time working from home In-house and external learning and development opportunities Fantastic benefits program as per the current policy including;Health Insurance providedMedical Check-up, flu vaccine reimbursementHome-office setup allowanceMonthly reimbursement for home office expenses (i.e. internet, mobile..)Wellness benefits (Employee Assistance Program)Paid parental leaveAnnual leaveMarriage leave and allowance, condolence leave and allowanceAnd more as the benefit programs keep improvingPlus you get to work with a dynamic team of collaborative, supportive, diverse, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
BeiGene is proud to be an Equal Opportunity Employer:
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