About this role
About the Role
Permanent, Full Time
Christchurch or Auckland Location
Join NZCR's Start Up team and play a critical role in bringing clinical trials to life. Reporting to the Start Up Team Lead, you'll lead ethics and regulatory submissions, manage study start-up processes, and work closely with sponsors, CROs, investigators, and internal research teams to ensure studies are approved and ready to commence.
Key Responsibilities
• Prepare and submit HDEC, Māori, Medsafe and RRC applications
• Draft participant information sheets and informed consent forms
• Act as the primary contact for study start-up activities
• Liaise with sponsors, CROs, investigators and regulatory bodies
• Maintain start-up timelines, tracking tools and documentation
• Ensure compliance with NZ and international regulatory requirements
• Support study teams with documentation and approval processes
• Manage amendments and substantial changes to approved studies
• Establish and maintain key stakeholder agreements
• Identify, escalate and communicate study start-up risks and issues
Skills & Experience
• Degree in Life Sciences or a related discipline
• Clinical research experience in start-up or regulatory activities
• Experience preparing HDEC and regulatory submissions
• Understanding of ICH-GCP, NEAC and NZ regulatory frameworks
• Strong organisation, communication and stakeholder management skills
Benefits
• Discretionary bonus opportunities
• Generous employee referral bonus programme
• Retail discounts and exclusive deals
• Leadership development and learning pathways
• Access to AI tools, training and Trans-Tasman career opportunities
• Wellbeing and connectedness programme
• Generous leave entitlements from day one
• Join a globally respected organisation advancing global health
About NZCR
Established in 2020 through the merger of Auckland Clinical Studies and Christchurch Clinical Studies Trust, NZCR is New Zealand's leading early-phase clinical research organisation. Across Auckland, Christchurch, Wellington and Hamilton, our physician-led teams partner with global pharmaceutical and biotech companies to advance new medicines and improve health outcomes worldwide.
People enjoy working at NZCR because we're united by a shared purpose, advancing global health. We support each other's growth, celebrate success together, and encourage new ideas that help us find better ways of working. Our values guide everything we do: We Do What's Right, We're In It Together, We Strive for Excellence, and We Find Better Ways.
For more information about NZCR, visit www.nzcr.co.nz.
To be considered for this role, you must have current New Zealand working rights. Please submit your CV and cover letter by clicking Apply.
When you apply for this role, you consent to NZCR sharing your application with our sister company, Optimal, where additional career opportunities may arise.