New Zealand Job Openings
BeiGene
(Senior) Clinical Research Associate (New Zealand Wide & home-based)
FULL TIME
August 22, 2024
Job Description:
How you will add value:
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Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit), if require
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Conducts co-monitoring visits, if required
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Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
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Attends onboarding-, disease indication and project specific training and general CRA training as required
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Documents monitoring activities appropriately following ICH-GCP and Bei Gene standards
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Conducts Quality Oversight Visits (QOV), as requested
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Completes monitoring visit/ QOV reports timely
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Assists with investigator/site identification
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Assists site to prepare Ethics Committee submissions
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Facilitates clinical trial site contract and budget negotiation
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Manages site queries and communications
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Assists in managing clinical trials, if required
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Establishes regular lines of communication with sites and COMs
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Provides protocol and related study training to assigned sites
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Evaluates the quality and integrity of site practices – escalating quality issues as appropriate
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Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
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Collaborates with CRA Group / CRM to ensure recruitment plans and execute contingency plans, as needed
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Performs additional task as assigned
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Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical
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Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
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+1 year (Over 4 years for SCRA) of monitoring experience in the pharmaceutical or CRO industry
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Excellent communication and interpersonal skills
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Excellent organizational skills and ability to prioritize and multi-task
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Fluent in English (writing and speaking)
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Applicant must have full New Zealand working rights to be considered.
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Market competitive compensation package including performance-based annual bonus scheme
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Company shares (generous welcome grant and performance-based annual equity plan!)
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Full-time working from home (with an option to work from the Sydney office, available soon)
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In-house and external learning and development opportunities
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Fantastic benefits program as per the current policy including;
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Personal health insurance reimbursement
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Home-office setup allowance
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Monthly reimbursement for home office expenses (i.e. internet, mobile..)
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Group life insurance & income protection insurance
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Wellness benefits (Employee Assistance Program)
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Paid parental leave
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Active social club
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And more as the benefit programs keep improving!
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We are proud to be an equal opportunity employer and we value diversity. Bei Gene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
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