Study Protocol review and study feasibility prove
Review of all other study related documents e.g., CRF, Lab Manual, Reference Manual
Review Protocol Deviation Assessment Plan (PDAP) and Data Verification Specification (DVS). Be involved in project development, taking part in early internal project discussions.
Early recognition of areas of potential problems, provide contingency plans or address the issue in an appropriate way with the required departments and give input into possible solutions (RACT).
Escalate issues as soon as possible. Open QI in timely manner, close actions on or before the end date.
Record Clinical including medical deviations on the Observable protocol deviations (PD) log.
Review combined PD log.
Generation of general working instructions, source data sheets and other relevant forms and documents for the allocated clinical studies
Generation and maintenance of the general and emergency case files, Staff Log, Window Allowance Agreement, Source Data Verification
Training / Training organization of personnel assigned to the study
Organization of study specific training
Organization of the generation of dietary plans/meal plans
Verification and maintenance of the file containing the volunteers informed consent forms
Organization of study specific material and medical devices
Lead ClinBase setup development across pharmaceutical services, laboratory, database design, and clinical operations for all assigned studies
Monitor that ClinBase set up activities and ensure that it is developed within the given time.
Prepare ClinBase set-up requirements forms for Screening and Experimental.
If EDC is in use review annotated CRF and perform UAT.
Review the ClinBase set up procure list, time windows, normal ranges as part of pre-dummy review.
Check User Defined Procedures on Feasibility
Approve the set up for Clinical use to ensure study requirements are captured as per protocol and in accordance with sponsor requirements (WAA, Normal Ranges, Lab Profile, order of procedures, relative time User Defined Procedures)
Initiate ClinBase revisions and subsequent approval.
Care support of the volunteers participating in a study from admission to discharge
Coordination of study-preparations on the ward incl. providing medical technique, sample container, documentation computers, bed
Providing study relevant shift to shift information
Ensuring all study related assessments and medical measurements will be performed according to study protocol and relevant clinical guidelines (GCP and ICH guidelines)
Ensuring all study relevant documentations are going to performed according to study protocol and ICH/GCP guidelines
Overseeing, maintaining, and leading the processes and progresses of all allocated studies in conjunction with study physician, project management and data management
Volunteer payment management
Management/Organization of medication storage, drug check in and out
Issuing of Audit Reports on internal and external quality audit findings
Resolution of data clarification queries
Management of CRF Shipment, Source Data storing and archiving after study finalization
