Assists in managing Clinical Operations personnel in protocol development, Institutional Review Board submissions, scheduling, staffing, work flow and any other requirements necessary for the initiation, conduct, and completion of a clinical project.
February 25, 2020
Provide oversight of project teams to ensure that the project is completed within compliance of all regulatory bodies, client and Caris Pharmatech SOPs, and the project contract requirements.
March 30, 2020
Participates in meetings with internal Grifols departments including Quality, Stability, Regulatory, and Bio Analytics.
April 16, 2020
Tracks in a coordinated manner the IRB approval process, contract execution, ancillary approvals, credentialing requirements, and other study start-up requirements in partnership with study teams.
April 17, 2020
Reviews and coordinates internal project team and external vendor project deliverables, ensuring standard processes are followed.
May 17, 2020
Develops quality assurance plan and provide ongoing monitoring of study performance, including data entry, inventory, recruitment, retention, and compliance with the protocol.
May 21, 2020
Serves as liaison to study sponsors, clinical trial sites, pharmacy department, clinical and research laboratories, contract research organizations, study principal investigators, study medical monitors, biostatistics department, data management unit, and administration/fiscal unit, as needed.
May 30, 2020