Senior Clinical Research Associate - St. Marys, United States - Quantum Innovations

Quantum Innovations
Quantum Innovations
Verified Company
St. Marys, United States

3 weeks ago

Meredith Sinclair

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Meredith Sinclair

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Description
At St. Marys AllucentTM, our mission is to assist small-medium biopharmaceutical companies in efficiently navigating the complex world of clinical trials to bring life-changing treatments to patients worldwide. We are currently seeking a Sr. Clinical Research Associate (Sr. CRA) to join our A-team (hybrid*/remote). As a Sr. CRA at St. Marys Allucent, you will be responsible for independently monitoring investigational sites, identifying and resolving issues, and ensuring that clinical studies are conducted in accordance with the trial protocol, SOPs, regulations, and Good Clinical Practice principles.

In this role, your key responsibilities will include:

  • Establishing quality standards for trial monitoring activities.
  • Conducting Selection, Initiation, Monitoring, and Closure Visits at Investigator Sites according to project schedule and adhering to project guidelines and Allucent SOPs.
  • Monitoring activities at clinical study sites to ensure compliance with GCP, ICH, SOPs, and study protocols.
  • Tracking and supervising the collection of ongoing study data for regular project status reporting.
  • Collecting and reviewing regulatory documents as required.
  • Preparing site visit reports and telephone contact reports.
  • Maintaining and updating CTMS in compliance with SOPs and study-specific directives.
  • Serving as Document Owner for collected documents.
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