Job Description:
The CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Hematology clinical trials within the country.
The CRA is responsible to deliver data within timelines and required quality standards, responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.
How you will add value:
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 Bei Gene 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:
Additional Job DescriptionWhat we expect from the successful candidate:
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 year (Over 4 years for SCRA) of 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)
Applicant must have full New Zealand working rights to be considered.
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