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.
May 18, 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.
June 04, 2020
Reviews and coordinates internal project team and external vendor project deliverables, ensuring standard processes are followed.
July 14, 2020
Participates in meetings with internal Grifols departments including Quality, Stability, Regulatory, and Bio Analytics.
July 27, 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.
July 27, 2020
Requires excellent organizational, planning, verbal, written and numerical skills with the ability to analyze and define solutions and manage multiple tasks to meet strict deadlines.
August 07, 2020
Develops quality assurance plan and provide ongoing monitoring of study performance, including data entry, inventory, recruitment, retention, and compliance with the protocol.
August 13, 2020
Lead regular telephone and/or face-to-face meetings with the project team and with the client team to discuss project status, problems, teamwork, or new plans.
August 24, 2020
Manages and maintains appropriate levels of CTM supplies for assigned trials throughout lifecycle of trial per GCP/GMP including initiating and tracking CTM shipments, shipment receipts, depot inventories, site inventories, IVR-IWR functionality, lot numbers, expiry dates, packaging randomization codes, drug accountability, and other necessary documentation as defined on a per study basis.
September 12, 2020
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.
September 26, 2020