Tracy Daugherty Email & Phone Number

Clinical Trial Management: Attend Business Development Hand-Off and Kick-Off Meetings for projects. Review the study scope of work, budget, and protocol content. • Collaborate with the Project Manager (PM), CRAs, and In House CRA/Research Associate (RA) to assure timely site initiation process. Assist the PM with tracking site initiation status including IRB approvals and scheduling of site initiation visits to coincide with shipment of clinical supplies, communicate with the regional team to assure understanding of the study timelines and compliance with clinical deliverables.

Morrisville, Nc, Us

CRO, Line Management, CTMS, EDC, ICH-GCP, Regulatory Compliance, Senior Clinical Team Lead:• Line Management of CRAs: Responsible for the supervision of all direct reports, establish and monitor quality and performance expectations on an ongoing basis. Facilitate teamwork, influence and motivate team to accomplish goals by encouraging direct and open communication, resolving conflict and demonstrating support to team members. Inform Director, Clinical Operations of CRA activities, concerns, etc. • Provides training to CRAs on protocol, CRF completion, sponsor SOPs, and clinical plans and guidelines for the study • Clinical Trial Management: Attend Business Development Hand-Off and Kick-Off Meetings for projects. Review the study scope of work, budget, and protocol content. • Collaborate with the Project Manager (PM), CRAs, and In House CRA/Research Associate (RA) to assure timely site initiation process. Assist the PM with tracking site initiation status including IRB approvals and scheduling of site initiation visits to coincide with shipment of clinical supplies, communicate with the regional team to assure understanding of the study timelines and compliance with clinical deliverables.

Site management activities include all in-house and on-site monitoring for all visit types;Responsibilities included verifying test article accountability, reviewing regulatory document files, conducting potential investigator interviews, and adequately documenting these activities;Therapeutic focus: Oncology