Start Up Associate

New Zealand Clinical Research; Auckland; On-site; NZD 90,000 - 120,000; Full time

Benefits offered by this job

Discretionary bonus

Referral bonus programme

Retail discounts

Leadership development

AI tools access

Wellbeing programme

Generous leave from day one

Job summary

New Zealand Clinical Research is seeking a Start-Up Regulatory Lead to drive ethics and regulatory submissions in its Start Up team. You will manage study start-up processes and collaborate with sponsors, CROs, investigators, and internal teams to ensure timely approvals and readiness to commence studies.

The role requires a life sciences degree and experience in regulatory submissions, with a strong grasp of NZ and international regulatory standards.

Qualifications

• Degree in Life Sciences or related discipline.
• Clinical research experience in start-up or regulatory activities.
• Experience preparing HDEC and regulatory submissions.
• Understanding of ICH-GCP, NZ regulatory frameworks.
• Strong organisation, communication and stakeholder management skills.

Responsibilities

• Prepare and submit HDEC, Māori, Medsafe and RRC applications.
• Draft participant information sheets and consent forms.
• Act as the primary contact for start-up activities.
• Liaise with sponsors, CROs, investigators and regulators.
• Maintain start-up timelines and documentation.
• Ensure compliance with NZ and international regulatory requirements.
• Support study teams with documentation and approvals.
• Manage amendments and significant changes to studies.
• Establish and maintain stakeholder agreements.
• Identify and communicate start-up risks and issues.

Skills

Clinical start-up experience

Regulatory submissions

Stakeholder management

Organizational skills

Communication

Education

Degree in Life Sciences

Tools

HDEC submissions

NZ regulatory frameworks (NZRFB)

Job description

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, escalation 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.

When you apply for this role, you consent to NZCR sharing your application with our sister company, Optimal, where additional career opportunities may arise.