About this role
PI responsibilities and qualifications for the Dutch Colorectal Cancer Group (DCCG) The DCCG board bears the final and overall sponsor responsibility for all DCCG trials. DCCG delegates to the Principal Investigator (PI) the responsibility to safeguard the progress, safety and validity of the trial. The PI is coordinating the trial on behalf of DCCG and bears executive responsibility for the overall conduct of the trial. The tasks of the PI in all DCCG trials include the following: - Inform DCCG and Central Datamanagement Office (data center) of a new trial - Collaborate with data center to compose and approve a project plan for the trial - Ensure that all logistic requirements of the trial are arranged before start of the trial (supply of trial medication, courier services for sample collection, services and procedure central labs, services and procedure central review, etc.) - Ensure that a Data Safety and Monitoring Board is installed - Ensure that a protocol writing committee is appointed - Provide data on the feasibility of the trial, and perform site selection - Provide draft version of protocol and informed consent form to data center - Provide trial related manuals for data center (lab manuals, nursing guideline) - Collaborate with data center in editing protocol, ICF, CRF and other trial documents into a final version - Review and sign for approval final version of protocol, ICF, CRF and other trial documents - Sign application letters to Ethics Committees, Competent Authorities and other institutions that need to approve the trial - Answer questions/respond to comments by Ethics Committees, Competent Authorities and other institutions that need to approve the trial - Speak at investigator meetings, inform participating investigators about the medical and scientific aspects of the trial - Speak at other training meetings for the trial: training of local data managers, training of data center staff (safety, monitori...