Responcibilities of CRA

In accordance with the sponsor’s requirements CRA should ensure that the clinical trial is conducted and documented properly by carrying out the following activities:

• CRA must act as the main line of communication between the sponsor and the investigator.
• Verifying that the investigator has adequate qualifications and resources and remain adequate throughout the trial period, facilities, including laboratories, equipment, and staff, is adequate to safely and properly conduct the trial and remain adequate throughout the trial period.
• The storage times and conditions are acceptable, and that supplies of the Investigational product(s) are sufficient throughout the trial and the investigational product(s) are supplied only to subjects who are eligible to receive it as per the dose(s) i.e. protocol specific.
• The subjects are provided with adequate instruction on using, handling, storing, and returning the investigational product(s) properly and the receipt, use, and return of the investigational product(s) at the trial sites are documented adequately.
• The disposition of unused investigational product(s) at the trial sites should comply with regulatory requirement and is in accordance with the sponsor.
• CRA should also verify that written informed consent is obtained before each subject’s participation in the trial.
• CRA even ensures that the investigator receives the approved Investigator’s Brochure, all documents, and all trial related supplies needed to conduct the trial properly and in compliance with the regulatory requirement(s).
• CRA ensures that the investigator and the investigator’s trial staff are adequately informed about the trial.
• CRA verifies that the investigator and the trial staff are performing the specified trial functions, in accordance with the protocol.
• Enrolling only eligible subjects are Investigator responsibility which has to be monitored by the CRA and reporting the subject recruitment rate to the sponsor.
• CRA verifies the required reports, notifications, applications, and submissions, done by the investigator are accurate, complete, timely dated, and identify the trial.
• CRA Checks the accuracy and completeness of the case report forms (CRF) entries, source documents and other trial-related records against each other.
• Consistency between the CRF’s and the source documents and any dose and/or therapy modifications are well documented for each of the trial subjects by CRA
• Adverse events, concomitant medications are reported in accordance with the protocol on the CRFs. The visit failure of the subject and the tests that are not conducted should be clearly reported in the CRF’s.
• All withdrawals and dropouts of enrolled subjects from the trial are reported and explained on the CRFs.
• CRA informs the investigator of any CRF entry error, omission. The CRA should ensure that appropriate corrections, additions, or deletions are made, dated, explained.
• Time period of reporting the AE’s should be as per the GCP guidelines and the protocol is determined by the CRA.
• Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and taking appropriate action designed to prevent recurrence of the detected deviations.

Career Opportunities

Clinical Research Associate(CRA) is one of the most sought after jobs in USA especially for the people from life sciences background. The requirement for qualified & certified CRA’s is very huge in USA and all over the globe as well. The reason is very simple because CRA would have the majority share in the success of a clinical trial especially when it is multicentric with many sites located at different locations. The career growth for a CRA would be very phenomenal. In most cases career for a CRA starts with designation of ACRA (Assistant Clinical Research Associate) followed by CRA –I, CRA – II, CRA –III …… etc and can easily reach upto Associate Director for Clinical Research.

. The opportunities this particular section of Clinical Research industry are enormous and only thing an aspiring life science graduate need to do is a decent certification program of CRA from some reputed training academies or CRO’s. Various positions available for a certified CRA are:

• ACRA
• CRA – I
• CRA – II
• CRA – III
• Senior CRA
• CTA (Clinical Trial Assistant)
• Clinical Monitoring Associate
• Research Operations Assistant
• Clinical Operations Manager
• Project Assistant
• Home based CRA etc…

The typical salary range for an entry level CRA would be around 60,000-70,000 US Dollars per annum and can reach up to 3, 00,000 US dollars depending on the position and experience of the CRA. Alternatively an experienced CRA can work independently i.e. as a freelancer or even can do a home based role. This is one of the rare job profile which is highly paid and demanding.