Experience

Marquee Staffing

• United States
• Staffing and Recruiting
• 1 - 100 Employee

• Clinical Research Associate

  • Sep 2022 - Present

  • Performed complete reporting and proper documentation of monitoring activities. • Perform on-site and remote monitoring and study closure activities across multiple sites. • Plan implement and conclude clinical study in support of project timelines. • Performed complete reporting and proper documentation of monitoring activities (e.g., complete monitoring reports promptly, follow up with site to complete open action items) • Ensure sites identify issues and implement corrective and preventive actions to ensure inspection readiness. • Monitor safety review and adverse events reporting for investigational medical devices to ensure adherence to good clinical practice (GCP), FDA and MDD regulations. • Ensure accountability of Investigational Device and study supplies are performed, when appropriate to the study. • Conduct pre-qualification, initiation, routine monitoring, and close-out visits in accordance with the relevant SOPs. • Help in the day to day running of projects assigned. • Perform clinical reviews of individual patient listings • Performed feasibility studies for potential sites as requested, conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements, worked with Project Management to evaluate deliverables and study milestones, compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.). Show less



ICON plc

• Ireland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Clinical Research Associate

  • Mar 2016 - Aug 2022

  • Participates & provides inputs on site selection and validation activities. • Perform remote and on-site monitoring & oversight activities using various tools to ensure data generated at the site are complete, accurate and unbiased. • Ensure subject’s right, safety, and well-being are protected. • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits. • Records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner. • Collect, review, and monitor required regulatory documentation for study start-up, study maintenance, and study close-out. • Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections, and overall site performance. • Identify assess and resolve site performance, quality or compliance problems and escalate per defined Clinical Research Associate (CRA) Escalation Pathway as appropriate. • Manage and maintain information and documentation in the Clinical Trial Management System (CTMS), electronic Trial Master File (eTMF) and various other systems as appropriate and per timelines. • Contribute strongly to CRA team knowledge by acting as process Subject Matter Expert (SME), sharing best practices, making recommendations for continuous improvement and providing training as appropriate/required. • Support and/or lead audit/inspection activities as needed. • Mentor junior CRAs on process/study requirements and perform co-monitoring visits where appropriate. Show less