Clinical Research Operations Coordinator
hace 21 horas
We are a dynamic and innovative company founded in 1995, with over 2,800 driven individuals worldwide.
Our organization prioritizes the well-being of our staff, clients, partners, and the quality of our work. We are at the forefront of medical science, developing new medicines that change lives.
As a key member of our international team, you will play a crucial role in supporting clinical research projects by streamlining communication, maintaining systems, and managing documents & information.
You will be responsible for:
- Serving as the primary point of contact between site personnel and Contract Research Associates (CRA), resolving queries and completing Electronic Data Capture (EDC) tasks.
- Managing vendors, study supplies, and access control.
- Ensuring pre-study testing of local site facilities is completed.
- Collaborating with Monitors to complete subject event and site event information in Clinical Trial Management Systems (CTMS) and tracking site issues and action items.
- Overseeing clinical supplies, including ordering, receiving, inventory storage, distribution, return/recall, and reconciliation.
- Coordinating regulatory and ethics committee submissions and notifications.
- Facilitating site, TMF, and systems audits and inspections.
- Managing Trial Master File (TMF) and Investigator Site Files, including document preparation, distribution, and updates.
- Organizing project training for site teams in vendor-related systems.
- Documenting management and translation status reviews of the study.
To succeed in this role, you will require a College/University Degree in Life Sciences, administrative experience, preferably in an international setting, and prior experience working as a Clinical Trial Associate (CTA) for Contract Research Organizations (CROs) and in Clinical Research. Proficiency in MS Office applications, excellent communication and collaboration skills, and local regulations knowledge are essential.
This position comes with an attractive salary range of $60,000 - $80,000 per annum, depending on experience and location.
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