The clinical research assistant is also an important team member in an active clinical research program. The clinical research assistant can have varying job roles depending on the place at which they are working. It could be a clinical research assistant working with the primary clinical research coordinator at a clinical trial site. Thus, this clinical research assistant when delegated to a clinical trial protocol assists the primary clinical research coordinator in conducting clinical trial administrative activities and also may act as a back-up coordinator on days when the primary coordinator is not at site if he or she has been delegated to a particular protocol.
The general role of a clinical research assistant involves helping with filling of screening and enrollment logs and also further learns the activities done at a clinical trial site under the supervision of the Principal Investigator and primary clinical research coordinator . An assistant could help with data entry, source documentation maintaining, updating the trial master file and assisting the Principal investigator in his daily activities.
Having a clinical research assistant in a team, is a great pair of hands to help with the smooth conduct of the trial. A clinical trial site has many activities from maintaining source documents to maintaining and ordering supplies and updating inventories. It is important to see that the investigational product, if it has expired to be kept separately along with any other expired ancillary supplies. In addition, the other supplies should be ordered for the site which is usually done by the clinical research assistant. The clinical research assistant helps with the enrollment binders and reviewing patient diaries. The clinical research assistant too should have a deep knowledge of good clinical practice. The clinical research assistant too helps with regulatory submissions and filing safety reports too and reviews the feedback received. He or she works hand in hand with the clinical research coordinator to ensure timely submissions and ensure that the safety of the trial subjects are maintained.
In addition to the clinical research assistants at the site level, there could also be sponsor level clinical trial assistants too. They assist the clinical research associates, helping with the preparation of trial master files as well as FDA Form 1572 preparation and forming other templates to be sent to clinical trial sites. Usually, an in-house job role, the clinical research assistant works in meeting timelines and supports in meeting the company milestones with appropriate storing of documents by preparing for documentation audits. He or she may also be responsible for processing site payments and help with coordinating team meetings and in-house kick off meetings.
Thus, the clinical research assistant is an important member in the clinical trial industry and is a promising job role to enter where one can go on to more important job roles with promotions to become a clinical research coordinator or clinical research associate with more experience. It is a great role to learn more about working at a trial site or at a contract research organization.