Clinical/Medical Research (Healthcare & Medical)Full-TimeCompany Description Established in 2020 through the merger of Auckland Clinical Studies (ACS) and Christchurch Clinical Studies Trust (CCST), NZCR is at the forefront of early-phase clinical research in New Zealand. With over 35 years of combined research excellence, we have successfully completed 750 trials involving 15,000 participants, showcasing our commitment to advancing medical research. Our physician-led, world-class research units in Auckland, Christchurch, Wellington, and Hamilton conduct complex studies in both healthy participants and patient populations. Partnering with global pharmaceutical and biotech companies, we deliver excellence in clinical research and explore potential new medicines. Recognizing the pivotal role of study participants, NZCR prioritizes their safety and comfort through detailed study information, expert clinical care, and comprehensive support services.Our ValuesAt NZCR, our core values guide our actions and decisions:We Do What's Right: Integrity is at the heart of our organization. We are committed to ethical practices and doing what is right, even when faced with challenges.We're In It Together: Collaboration is key to our success. We foster a culture of teamwork and mutual support, recognizing that our collective efforts drive our accomplishments.We Strive for Excellence: Excellence is our standard. We continually push ourselves to achieve the highest quality in our research, services, and interactions.We Find Better Ways: Innovation is in our DNA. We actively seek improvements and embrace creative solutions, always looking for better ways to advance clinical research.The RoleReporting to the Head of Quality, the Senior Quality Assurance Advisor is responsible for supporting the wider team to deliver successful clinical trials that meet regulatory requirements. You will do this by ensuring the quality management system is maintained at the highest possible levels by:Manage document control processes, including writing SOPs and documents.Deliver quality-related training programmes.Conduct internal audits to ensure clinical trials and NZCR activities are conducted in accordance with SOPs, protocols, ICH-GCP, and other applicable regulations and guidelines.Conduct audits of vendors, ensuring their compliance with contractual obligations, trial protocol requirements, and regulatory standards.Support audits of NZCR conducted by external clients and regulatory authorities e.g. FDA or EMA.Managing the CAPA system and conducting root cause analysis investigations.A quality superstar who has a sound understanding of quality management principals.About You:Preferred 3-6 years' experience in a quality assurance role.Ability to communicate their ideas and works well in a geographically dispersed team (two sites).Good knowledge of the national and international regulatory and ethics principles, and procedures governing clinical research including ICH-GCP.Ability to gather information/data, compile information, prepare reports, and meet timelines.Preferred training in ISO:9001 (2015).Preferred audit training (internal or lead auditor).A logical and organised approach to problem solving, and ability to put information in context/perspective.Experience in a Research/Health/Medical industry preferred.Working with Q-Pulse preferred, but not essential.Experience in conducting root cause analysis investigations.A relevant professional qualification is also preferred.Additional Information: When you join us, we offer a range of benefits that work for you, your lifestyle and your career development which include: Boost - Employee Benefits Programme: Currently offering seventy-seven benefits, such as health insurance, gym memberships, discounts for Torpedo7 and more.Participation in the Farm Source discounts and rewards.Discretionary short term incentive payments permanent employment adds only Mentorship to advance your professional journey. Enjoy freshly brewed coffee from our coffee machines at all locations, complete with a choice of plant-based milk options. Engage in a vibrant workplace within a rapidly expanding company, providing opportunities for continuous learning, personal growth, and success. For more information about NZCR visit www.nzcr.co.nz.If you are interested in this great opportunity and you are available, please click Apply for this job to submit your CV and cover letter.To apply for this role, you must have a right to work in NZ and being fully vaccinated against Covid 19 is preferable.When you apply for this role, you are consenting to us sharing your information with our sister company, Optimal Clinical Trials, where additional opportunities for career growth and development may arise.Report this job advert Don't provide your bank or credit card details when applying for jobs. #J-18808-Ljbffr
