(Senior) Clinical Research Associate (New Zealand Wide & home-based)

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 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 :

Additional Job Description

What 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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