Audra Mcmillian Email & Phone Number

Raleigh-Durham-Chapel Hill Area

Raleigh-Durham-Chapel Hill Area

• Performed all site visits (e.g., selection, initiation, monitoring, and close-out visits)• Engaged and developed a global network of high-performing sites to create awareness of clinical studies • Supported Clinical Project Management in vendor management and oversight of CRO personnel

Raleigh-Durham-Chapel Hill Area

• Managed clinical trial sites to ensure adherence to protocol and ICH-GCP • Performed site qualification, initiation, interim, and close-out visits • Performed source data review and source data verification • Conducted investigational product (IP) accountability and reconciliation • Managed regulatory review of investigator site file

Raleigh-Durham-Chapel Hill Area

• Oversaw all aspects of the Monitoring and Site Management activities, including country performance matters for the assigned global Oncology Clinical Trials • Led the assigned Country Lead Monitors (CLM) and Clinical Research Associates (CRA) globally • Delivered study-specific training and quality oversight of monitoring and site activities • Developed the training materials for the CLM and CRA

• Developed and maintained investigator site relationships and served as the Sponsor operational point of contact• Drove study start up activities: established activation timelines, qualified sites, and managed issues impacting site activation• Identified issues with site and CRA performance and addressed significant quality events by implementing Corrective and Preventative Actions (CAPAs) as necessary

Raleigh-Durham-Chapel Hill Area