Site Activation Specialist

We are currently seeking a for a full-time 12-month fixed-term Paternity Leave contract, with the potential for this position to transition into a permanent opportunity. In this role, you will serve as the Single Point of Contact (SPOC) in assigned studies, acting as the primary liaison among investigative sites, Site Activation Manager (SAM), and the Project Management team. You'll be responsible for managing and executing start-up and site activation activities, including amendment activities at a country level.

We are open to considering applications from all across Australia and New Zealand for remote work opportunities.

Job Overview:

Your responsibilities will include performing start-up and site activation activities in accordance with applicable regulations, Standard Operating Procedures (SOPs), and work instructions. You will provide local expertise to SAMs and the project team during the initial and ongoing project timeline planning phases. Additionally, you will be responsible for preparing and reviewing ethics and regulatory documentation, ensuring their completeness and accuracy. Monitoring and tracking the progress, approval, and execution of various documents such as questionnaires, regulatory submissions, ethics approvals, Informed Consent Forms (ICFs), and Investigator Pack (IP) release documents will be a crucial part of your role.

You will also review, prepare, and negotiate study budgets and contracts with sites, while ensuring accurate maintenance of internal systems, databases, and tracking tools with project-specific information. Conducting quality control of documents provided by sites, obtaining the necessary documentation and approvals, and handling maintenance activities such as site budget and contract amendments will be among your key responsibilities.

Lastly, you will review site performance metrics and provide feedback to management based on your observations and analysis.

Qualifications:

• Bachelor’s Degree in Life Sciences or equivalent work experience
• 0 - 2 years’ experience Clinical Research or Site Start-Up within a CRO/Pharmaceutical Company, ideally in Australia/New Zealand
• Knowledge of clinical systems, procedures, and corporate standards
• Good communication skills, ability to negotiate and problem solve.
• Good interpersonal and organisational skills
• Ability to work on multiple projects balancing competing priorities
• Willingness to learn and embrace emerging technology
• Knowledge and ability to apply ICH GCP and applicable regulatory guidelines

If this sounds like you, please hit the APPLY button and the Talent Acquisition Team is looking forward to speaking with you!