Darlene Greene Email and Phone Number

• Conducted potential investigator feasibility to identify qualified sites and contributed to the site and investigator selection process for their area of responsibility by making appropriate recommendations and pre-investigational site visits to evaluate site facilities and staff to ensure protocol and Federal Regulations will be adhered to. • Worked closely with Sponsor ensuring accurate data is collected.• Responsible for planning, coordinating, and conducting pre-study evaluation visits, site initiation visits, interim monitoring visits and study closure visits regarding the implementation, monitoring, and summarization of clinical trials to ensure adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs.

• Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.• CRA confirmed Master IP log and Subject IP log, shipment, dispensing and accountability records remain adequately documented without any issues.• Clinical study site management/monitoring activities in compliance Good Clinical Practice, Sponsor Standard Operating Procedures, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Monitoring visits have consisted of site selection, study initiation and close-outs.• Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File, and various other systems as appropriate and per timelines.• Monitor the progress of clinical studies, either at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. • Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined Clinical Research Associate Escalation Pathway as appropriate in collaboration with Clinical Research Manager, Partner Line Manager and Regional Clinical Project Manager.