Job Description: Clinical Research Associate (CRA)

Position Overview

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts. Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.

Location/Division Specific Information

This home-based position requires candidates to currently be resident in New Zealand, located within proximity of a well-connected air travel hub, ideally Auckland.

Requirements

• Three or more years of onsite monitoring experience.
• At least 1 year of experience within New Zealand.
• Ability to travel 40%-60% nationally, and occasionally internationally, dependent on business needs.

Responsibilities

• Performs and coordinates all aspects of the clinical monitoring and site management process.
• Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation.
• Manages procedures and guidelines from different sponsors.
• Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects' rights, well-being, and data reliability.
• Ensures audit readiness.
• Develops collaborative relationships with investigational sites.
• Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
• Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
• Assesses investigational product through physical inventory and records review.
• Documents observations in reports and letters in a timely manner using approved business writing standards.
• Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution.
• Maintains regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved, and that the data is being recorded in a timely manner.
• Conducts monitoring tasks in accordance with the approved monitoring plan.
• Participates in the investigator payment process.
• Ensures a shared responsibility with other project team members on issues/findings resolution.
• Investigates and follows-up on findings as applicable.
• Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.
• Ensures study systems are updated per agreed study conventions (e.g., Clinical Trial Management System).

Employment Details

• Employment Type: Full time
• Work Schedule: Standard (Mon-Fri)
• Environmental Conditions: Office

Application Instructions

• (No specific application instructions were provided in the original text.)

Company Information

• Company: Thermo Fisher Scientific
• Mission: Enabling our customers to make the world healthier, cleaner and safer.
• Portfolio: PPD® clinical research services