Reviews and coordinates internal project team and external vendor project deliverables, ensuring standard processes are followed.
July 18, 2021
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.
October 18, 2021
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.
November 02, 2021
Participates in meetings with internal Grifols departments including Quality, Stability, Regulatory, and Bio Analytics.
November 19, 2021
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.
December 13, 2021
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.
December 18, 2021
Develops quality assurance plan and provide ongoing monitoring of study performance, including data entry, inventory, recruitment, retention, and compliance with the protocol.
December 29, 2021