Senior Clinical Research Associate

• Apr 2014 - Present

• Lead CRA on multiple projects • Oversee CRO monitoring team on macular degeneration studies • Oversee and liaise with Central lab and other CROs in regards to setup and ongoing study activities related to ongoing studies • Perform the clinical monitoring aspects of designated projects in accordance with applicable SOPs • Clinical on-site monitoring activities such as driving patient recruitment, source data verification, drug accountability, & data collection • Collecting regulatory documentation and performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines Show less

Contract Senior Clinical Research Associate

• Aug 2012 - May 2014

• Therapeutic experience: Oncology (Non Small Cell lunc Cancer), Neurology (Pediatric Seizures, POS, PGTC). Perform the clinical monitoring aspects of designated projects in accordance with applicable SOPs • Clinical on-site monitoring activities such as driving patient recruitment, source data verification, drug accountability, & data collection • Collecting regulatory documentation and performing qualification, initiation, monitoring and termination of investigational sites in accordance with ICH GCP guidelines • Act as an independent CRA Coordinator on complex or multiple projects, CRA Coordinator on smaller projects • Represent function in external client meetings and presentations such as investigator meetings and bid defenses as required • Function as mentor and role model for other CRA team members to ensure study specific training for CRAs Show less

Sr. Clinical Research Associate III

• Aug 2011 - Aug 2012

• Therapeutic experience Pain management, Osteoarthritis. Provide monitoring visits and site management for a variety of protocols that are complex and/or require knowledge in advanced therapeutic areas • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation Show less

Lead Clinical Research Associate

• Sep 2009 - Aug 2011

• Therapeutic experience: Medical Device (open abdomen), critical care. • Senior Clinical Research Associate (Lead CRA)– Critical Care, Wound Care - Device • Conduct initiation, routine monitoring and close-out visits for investigative sites. • Educate investigators and study staff on protocol procedures and safety profiles of investigational products. Ensure adherence of clinical sites to all FDA regulations, ICH guidelines, and clinical protocol in conjunction with Good Clinical Practices. • Assist with writing protocol amendments and administrative changes for two protocols. • Develop eCRF including writing edit checks. • Lead CRA coordinating implementation and oversight of monitoring activities of team of 4 CRAs. Show less

Contract Clinical Research Associate

• 2000 - 2009