
Clinical Research Professional
1 week ago
Sydney-based Interim Contract
">This role is a critical component of our site activation process for clinical trials, requiring feasibility assessments, regulatory submissions, contract negotiations, and document tracking.
As a key member of our team, you will operate under moderate supervision, coordinating with internal teams and external sites to ensure timely and compliant study startup and maintenance.
">Key Responsibilities:">- ">
- Act as Single Point of Contact (SPOC) for assigned sites during feasibility and activation.">
- Prepare, review, and distribute site documentation, including CDAs, ICFs, and 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.">
- Evaluate contract execution and compliance with local/international regulations.">
- ">
- 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 the above.">
- Familiarity with regulatory and ethics submissions, ICFs, and site documentation.">
- ">
- 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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