
Site Activation Specialist 1
2 weeks ago
Sydney only, 3-6 month interim contract in our FSP team. Immediate start.
This role involves supporting the **site activation process** for clinical trials, including feasibility assessments, regulatory submissions, contract negotiations, and document tracking. The position operates under moderate supervision and requires coordination with internal teams and external sites to ensure timely and compliant study startup and maintenance. Site Activation Specialists are responsible for site selection visits for new studies (which can require some travel), initial and protocol amendment submissions.
**️**Key Responsibilities**:
- Act as the **Single Point of Contact (SPOC)** for assigned sites during feasibility and activation.
- Prepare, review, and distribute **site documentation** (e.g., CDAs, ICFs, regulatory forms).
- Track and manage **site performance metrics** and document status.
- Maintain **internal systems and databases** with up-to-date project information.
- Collaborate with **Site Activation Managers, Project Managers**, and other stakeholders.
- Ensure **contract execution** and compliance with **local/international regulations**.
***:
***Qualifications**:
- ** Education**: Bachelor’s degree in Life Sciences or related field.
- ** Experience**:
- 1-3 years in clinical research or a related field.
- 3 years in a healthcare environment (can overlap with above).
- Familiarity with regulatory and ethics submissions, ICFs, and site documentation.
***:
***Skills & Competencies**:
- Strong **organizational and communication** skills.
- Ability to manage **multiple priorities** and meet deadlines.
- Knowledge of **clinical trial regulations** (ICH-GCP, local laws).
- Experience with **clinical trial management systems (CTMS)** and document tracking tools.
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