The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade & frequently costs $1B+. And the problem is only getting worse.
TrialSpark is a technology company that brings new medical treatments to patients faster. Were reimagining the clinical trial by introducing a new model, using technology to streamline every aspect of the trial. To fulfill our mission, we partner with pharma, biotech, & digital health companies to run studies faster & more efficiently.
About The Role
As a Quality Assurance Coordinator you will be reporting to the Head of Quality Assurance. The Quality Assurance Coordinator will assist the Quality Assurance team in maintenance, organization & tracking of QA files & metrics.
Responsibilities are, but not limited to:
- Assist in QA files including: training, contractor/consultant, inspection, & audit & responses files
- Coordinate & maintain tracking of the audit process, including: assigning audit numbers, tracking audit process timelines, confirmation receipts & completion of CAPAs
- Issue & distribute audit documentation such as audit reports & audit responses
- Prepare information/data for management reporting
- Administration of Learning Management System
- Assist in managing Document Management System /Learning Management System workflows. Support in the development of Quality Assurance dashboards, quality metrics (Key Quality Indicators) , management reports as needed.
- Manage & oversee various QA administrative tasks as needed.
- Prior experience in managing quality systems (controlled documents, training platforms, learners), Document Management Systems
You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.