Trial Operations Lead
3 days ago
This role requires a high degree of autonomy, with ability to work independently and make decisions in a fast-paced environment.
Job DescriptionAs a Clinical Research Associate, you will be responsible for managing clinical trials from start-up to close out.
- You will work closely with investigators and site staff to ensure that studies are implemented according to protocol.
- You will assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites.
- You will identify and evaluate potential data quality and integrity issues and determine appropriate follow-up actions.
Main Responsibilities:
- Study Start-up and Maintenance:
- Conduct remote Qualification Visits (QVs), generate visit/contact reports, and develop strategy to configure, distribute, collect, review, and approve country/site specific documents or essential regulatory documents.
- Site Management:
- Build relationships with investigators and site staff, facilitate and support site access to relevant study systems, and ensure compliance with project specific training requirements.
Requirements:
- Able to work independently, seeking/taking guidance when necessary, with sound presentation skills and client-focused approach to work.
- Able to manage multiple tasks and achieve project timelines, with strong computer skills including knowledge of CTMS, EDMS, and MS-Office products.
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