Start Up Associate

NZCR Clinical Trials; Auckland; On-site; NZD 70,000 - 100,000; Full time

Benefits offered by this job

Generous leave entitlements from day 1

Leadership development and learning

AI tools, training and Trans-Tasman机会

Retail discounts and exclusive deals

Wellbeing and connectedness programme

Referral bonus programme

Job summary

NZCR Clinical Trials in Auckland, North Island, is seeking a Start Up professional to lead ethics and regulatory submissions and manage study start-up processes. You will collaborate with sponsors, CROs, investigators and internal teams to ensure studies are approved and ready to commence.

Reporting to the Start Up Team Lead, you will prepare HDEC, Māori, Medsafe and RRC applications, draft participant information sheets, act as the primary contact, maintain timelines and ensure NZ and

Qualifications

• Degree in Life Sciences or related discipline.
• Clinical research start-up or regulatory submissions experience.
• Experience preparing HDEC and regulatory submissions.
• Understanding of ICH-GCP, NEAC and 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 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

Organisational skills

Communication skills

Stakeholder management

Leadership development

AI tools access and training

Education

Life Sciences degree

Job description

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NZCR Clinical Trials – Auckland, North Island

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
• 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.

To be considered for this role, you must have current New Zealand working rights.