CRA II (Auckland Home based)

Overview

CRA II (Auckland Home based) role at Syneos Health.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model centers the customer and the patient, with a focus on simplifying and streamlining work to be easier to work with and for. Whether in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers to help customers achieve their goals. We are agile and driven to accelerate the delivery of therapies and to change lives.

Why Syneos Health : we are committed to developing our people through career development, supportive line management, training, recognition and total rewards; we maintain a Total Self culture; and we value diversity of thoughts, backgrounds, cultures, and perspectives so everyone feels they belong.

Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remote) ensuring regulatory, ICH-GCP and / or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Evaluates site and staff performance and communicates / escalates serious issues to the project team, developing action plans. Maintains knowledge of ICH / GCP Guidelines, relevant regulations, and SOPs / processes.
• Verifies informed consent processes and documentation; protects subject confidentiality; assesses factors affecting subject safety and data integrity at investigator sites, including protocol deviations / violations and pharmacovigilance issues.
• Per CMP / SMP : assesses site processes, conducts Source Document Review, verifies CRF data accuracy / completeness, resolves data queries, and supports site staff to close queries within timelines. Uses hardware / software to support data review and ensures IS / EDC compliance.
• May perform investigational product (IP) inventory, reconciliation, storage and security reviews; ensures IP dispensing per protocol and proper labeling, importation and release / return per GCP / local regulations.
• Routinely reviews ISF for accuracy and complete TMF reconciliation; ensures archiving of essential documents per regulations.
• Documents activities via letters, trip reports and logs; supports recruitment and retention strategies; enters data into tracking systems to monitor observations and actions to resolution.
• Understands project scope, budgets and timelines; manages site-level activities and communications to meet project objectives; adapts to changing priorities.
• Acts as liaison with study site personnel or Central Monitoring Associate; ensures sites and team members are trained and compliant with requirements.
• Prepares for and attends Investigator Meetings; participates in sponsor meetings and training as required.
• Provides guidance toward audit readiness and supports audit preparation and follow-up actions.
• Maintains knowledge of ICH / GCP Guidelines and SOPs; completes required training. For Real World Late Phase, the CRA II may use the business card title Site Management Associate II and may have site lifecycle responsibilities including site identification, chart abstraction and collaboration with sponsor affiliates and local staff. The SMA II may train junior staff and identify out-of-scope activities for escalation.

Qualifications

Note : This posting is intended for a possible upcoming opportunity rather than a live role. By expressing interest, you’ll be added to our talent pipeline and considered if the role becomes available.

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