Clinical Research Associate II/III - New Zealand

Role Overview

The Clinical Research Associate II/III is mainly tasked with safeguarding the rights and wellbeing of participants in clinical trials and verifying that collected data is precise, fully documented, and backed by source materials. Acting as the primary liaison among investigational sites, Novotech, and the study sponsors, the CRA ensures that all clinical research complies with ICH GCP standards, pertinent national and international regulations, and all company and client SOPs.

This position is based in New Zealand and benefits from flexible hybrid working conditions and adaptable work hours to support an optimal work-life balance.

Qualifications and Experience

• Bachelor's degree in clinical or life sciences or related disciplines; relevant allied health qualifications may also be accepted.
• Strong organizational and time management skills with meticulous attention to detail.
• Ability to collaborate effectively within multidisciplinary teams.
• Proficiency with computer and digital tools.
• Experience requirements: For CRA II, a minimum of 6 months of independent clinical monitoring; for CRA III, at least 2 years of independent clinical monitoring experience.
• Applicants must have unrestricted work authorization for New Zealand; sponsorship will not be provided.

Primary Responsibilities

• Establish and maintain strong working relationships with Principal Investigators, study coordinators, pharmacists, and other site personnel to facilitate efficient clinical trial management.
• Maintain positive internal and external stakeholder relations to ensure projects are delivered on time and meet all study criteria.
• Work closely with In-house CRAs and Regulatory Start Up Associates to organize essential documentation and aid ethics and regulatory submissions and approvals.
• Collaborate with the Regulatory Start-Up team to comprehend and adhere to applicable local and global regulatory guidelines relevant to specific studies.
• Ensure that participant recruitment targets at sites are met by supporting recruitment strategies and preparing/updating site-specific recruitment plans.
• Conduct monitoring visits per ICH GCP, including site selection, initiation, ongoing monitoring, closeout, unblinded pharmacy inspections, and co-monitoring, using both remote and onsite modes as stipulated by Clinical Monitoring Plans.

Company Commitment and Benefits

Novotech fosters an inclusive and supportive work culture, championing gender equality and diversity. The company promotes a respectful environment for all team members, including those from underrepresented communities such as LGBTIQ+, persons with disabilities, and individuals with caregiving responsibilities. Benefits include flexible work schedules, paid parental leave for all parents, flexible leave policies, wellness initiatives, and continuous professional development opportunities.

Novotech is a Circle Back Initiative Employer, ensuring each candidate receives a response regarding their application.