Start Up Associate Location: Auckland 3 Ferncroft Street Grafton Auckland Reports to: Start Up Team Lead Purpose of Role/Position Summary To provide start up, HDEC and regulatory expertise. To assist SUTL with key responsibilities. KEY RESPONSIBILITIES/TASKS Start Up: o Co-ordinates, writes and submits Ethics, Maori, Medsafe, RRC or any other relevant research applications.

o Maintains up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation. o Writes ICFs and any other documents related to the submission. o Serves as liaison and adviser related to HDEC/Reg as applicable.

o Attends EC meetings with PI as required. o Liaises with SC to transfer fully approved HDEC application o Manages substantial ICF changes, when necessary. o Primary contact for all site start-up activities o Ensures all start up information & requirements are kept up to date in a central repository for project teams.

o Liaises with relevant stakeholders such as sponsors, CROs and internal teams. o Maintains up to date and accurate tracking on the start-up status for each study. Other: o Assists SC in the preparation of study-related documentation.

o Set up and provision of agreements with key stakeholders such as PIs, referrers etc. o Documents/escalates study challenges and communicates updates to SUTL. o Performs other related tasks as required.

o Provides updates to SUTL on a regular basis and communicates any out of scope activities. MINIMUM POSITION QUALIFICATIONS Education: Min Bachelors Degree preferably in Life Sciences. Experience: Min 2 years of experience in clinical research area focusing on start-up or regulatory aspects of clinical trials.

Experience authoring or handling HDEC and regulatory submission deliverables. Strong understanding of local regulatory requirements including but not limited to NEAC guidelines and ICH GCP. KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED Must be self-motivated, well organised and able to follow carefully defined processes Excellent written and verbal communication skills essential.

Meticulous attention to detail. Skill in the use of a networked computer and Microsoft office applications such as Word/Excel. High level Excel skill due to budgetary component.

Ability to take responsibility for own work, and to work in a team Strong interpersonal and communication skills/friendly and personable manner Ability to work to tight deadlines and to accept and respond positively to change Excellent organizational skills Ability to manage multiple tasks with meticulous attention to detail. Previous administrative experience with a customer focused philosophy very desirable. I have read and understood this Position Description and accept the responsibilities outlined Full name: Signed: Date: Start Up Associate Operations Manager Signed: Date:.