CPA administers, maintains and co-ordinates the logistical aspects of clinical trials according to Good Clinical Practice and relevant SOP’s and acts as a pivotal point of contact for the clinical trial team and any contract organisation used.
CPA support study team for all administrative and logistical issue.
CRA has an important task within the clinical trial process. He or she has the responsibility to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents.
Most importantly, the CRA makes sure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement.
There are various levels at which a CRA can work. These differing levels determine the tasks and responsibilities to be carried out, and are often experience dependent.
CPL is responsible for ensuring success of project.
He or she managed his study team and act as a leader for other team member.
CPL remain often in charge of some sites but mainly coordinates between Sponsor and CRO team member.
Regulatory Officer (RO) is in charge of preparing submission dossier.
He or she is working closely with CPL and / or Project Manager to support them in regulatory submission tasks. He or she know very well all requirements for each submission and each country.
He or she is also involved in translation of study document in Arabic and French, in negotiation of contract with investigators and hospital and in pharmacovigilance safety submission