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Country Clinical Trial Activations Professional
2 semanas atrás
The role of Site Activation Specialist is crucial in ensuring the successful execution of clinical trials.
- This involves activating sites, providing quality deliverables at the country level, and adhering to project requirements and applicable country rules.
Key Responsibilities:
- Local Submissions Coordinator: Follows project direction provided by the designated country start-up advisor (CSA) and SAM.
- Regulatory Expertise: Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.
- Submission Specialist: Maintains ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed.
- Liaison and Facilitator: Acts as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues.
- Site Selection Support: Provides support with site selection lead and PM/SAM to ensure that appropriate sites are selected for individual studies based on requirements of the clinical trial.
Requirements:
- Associate's Degree or equivalent combination of education and training.
- Good understanding of clinical trial process across Phases II-IV and ICH GCP.
- Ability to interact effectively and appropriately with investigative site personnel.
- Good organizational skills and attention to detail, with proven ability to handle multiple tasks effectively.
- Ability to take direction from multiple individuals and set priorities accordingly.
- Strong computer skills, including Word, Excel, PowerPoint, Publisher.
