Clinical Research Associate Lead
4 days ago
We are seeking a skilled Clinical Research Associate to join our team at Abbott. In this role, you will be responsible for conducting monitoring visits and activities in accordance with FDA Code of Federal Regulations, GCP guidelines, departmental SOPs, Work Instructions, and the Clinical Monitoring Plan.
About the RoleAs a Clinical Research Associate, you will serve as the primary site contact, establishing and maintaining regular communication with clinical sites. You will conduct Site-Qualification, Initiation, Interim, and Closeout visits, including document review for accurate data recording, source data verification to protocol adherence and governing regulations.
You will also assist with distribution, collection, and tracking of regulatory documents for site compliance and audit readiness. Additionally, you will prepare and maintain monitoring visit reports and site communication documentation.
Responsibilities- Conduct monitoring visits and activities in accordance with FDA Code of Federal Regulations, GCP guidelines, departmental SOPs, Work Instructions, and the Clinical Monitoring Plan.
- Serve as primary site contact; establish and maintain regular communication with clinical sites.
- Conduct Site-Qualification, Initiation, Interim, and Closeout visits to include document review for accurate data recording, source data verification to protocol adherence and governing regulations.
- Assist with distribution, collection, and tracking of regulatory documents for site compliance and audit readiness.
- Prepare and maintain monitoring visit reports and site communication documentation.
This position requires working knowledge of clinical trial practices and regulations, clinical trial databases, proficient computer skills including Microsoft Office Suite, minimum BA or BS and 2 years of related clinical trial monitoring experience, on-site monitoring experience of IVD clinical studies is preferred.
Estimated Salary$76,600 - $144,800 per year, depending on location.
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