Description
Summary: * Extensive experience in clinical data management, pharmaceutical, and device research industries. * Experience working with Adverse Event Reporting and Medical Device Reporting. * Strong analytical, problem resolution, and project management skills. * Proficient in monitoring and managing record retention timelines for all clinical and regulatory documents and assistance in the preparation and review of documents for submission to regulatory agencies. * Expertise in addressing and solving initial problems related to document flow process, equipment dysfunction, abnormal pending requests or unforeseen situations without delay. * Proficient in providing assistance as required for Audits/FDA regulatory inspections. * Excellent written and verbal communication skills.
Work Experience
| COMPANY | POSITION HELD | DATES WORKED |
|---|---|---|
| Halyard Health/Lance Soft Inc. | Associate Regulatory Affairs Specialist I | 10/2015 - 3/2018 |
| Cardio Mems Inc. (Merged With St. Jude Medical Inc. In 2014) | Clinical Study Coordinator/Document Control Specialist | 11/2012 - 6/2015 |
| Quintiles/Clinforce Inc. | Associate Operations Specialist | 1/2011 - 1/2012 |
| Ucb Inc. | Drug Safety Coordinator Sr. Clinical Data Processor Data Management | 3/2004 - 10/2010 |
| Duke Clinical Research Institute | Clinical Data Assistant Ii Clinical Trial Services Clinical Trials Assistant Ii | 3/1993 - 3/2004 |
Accomplishments
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