Experience

Contego Medical, Inc.
• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee
• Senior Clinical Research Associate

  • Jan 2023 - Present


Syneos Health Clinical Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr. Clinical Research Associate I

  • Aug 2021 - Present

  Perform all site management activities from site selection to site close out. Participate in the investigator site identification process and perform site evaluation visits to ascertain site’s capabilities and suitability to conduct the clinical trial. Manage the site regulatory submission process to ensure that all bottlenecks are ironed out and that delay of the clinical trial start up are avoided. Conduct presentations and trained site personnel. Visit sites to perform ongoing site monitoring visits to conduct source data verification, drug accountability, query generation and resolution, SAE verification and reporting oversight, regulatory file review and oversight, document submission for central archiving, monitor reports, general site support and communication. Generate quality adequate monitoring visit reports. Schedule and perform site monitoring visits in accordance with study CMP. Close communication with site staff via phone call/email during off-site times. Perform troubleshooting and problem-solving tasks at sites to help achieve turnaround results. Show less



Syneos Health

• United States
• Biotechnology Research
• 700 & Above Employee

• Clinical Research Associate I-III

  • Aug 2018 - Aug 2021

  Performed all site management activities from site selection to site close out. Participated in the investigator site identification process and performed site evaluation visits to ascertain site’s capabilities and suitability to conduct the clinical trial. Managed the site regulatory submission process to ensure that all bottlenecks are ironed out and that delay of the clinical trial start up are avoided. Conduct presentations and trained site personnel. Completed monitoring visits per CMP Generate quality adequate monitoring visit reports. Close communication with site staff via phone call/email during off-site times. Escalated appropriate site/study related issues to study team/ sponsor Show less



Synexus Clinical Research GmbH

• Germany
• Research
• 1 - 100 Employee

• Clinical Research Coordinator

  • Feb 2016 - Mar 2018

  Overall conduct of multiple clinical trials. Recruiting, evaluating, and scheduling patients for studies appointments. Completed all required study related documents including; obtaining informed consent, Case Report Forms, Source documents, Data management queries, PDs and AE/SAE reporting. Ontime data entry after completion of subject visits Gathered missing or incomplete data. Collected and organized patient data. Tracked investigational product distribution and site inventory. Coordinated lab activities. Collected urine samples for testing. Maintained study manuals, regulatory binders and other materials. Completed IRB submission and approval process. Prepared site for monitoring visits. Show less