Routine Site Monitoring CRA

Question: Describe about the Responsibilities of CRA? Answer: Introduction According to Al-Sallami et al. (2010) Clinical Research Associate (CRA) also known as clinical monitor is a professional related to health care service that perform activities that are related to medical research specially in clinical trials. The primary objective and purpose is to prioritize the workload for meeting the timelines while multiplying protocols. This assignment deals with the job functions of the CRA along with their responsibilities. CRA CRA is Clinical Research Associate that are health care professionals those manages the assigned activities for ensuring the completion of the work in desired time and within budget in observance with a good practice clinically (Lankheet et al. 2014). The daily activities are managed as well as new methods and procedures are deployed for performing new assignments. In addition to this, the CRAs provides occasional; visits to those clinics where the sites are initiated until that gets closed. According to Seger and Vogeser (2010) the purpose of the CRAs is to protect the subject by monitoring them occasionally for ICH or GCP fulfillment. For that, the required tools and protocols are along with lab kits and study materials are planned and implemented according to the needs. Responsibilities of CRA Myers (2006) commented on the fact that the major responsibility of CRA is to perform visits that are essential for monitoring. The CRA qualifies potential sites for investigation and also train and initiate the sites of investigation. Moreover, they are also concerned with the routine monitoring visits are also close the visits. The CRA also is focused on completing the trips of monitoring accurately that are documented as well as inventoried. According to Murray et al. (2010) the CRA also helps in ensuring whether the site regulatory binder is current. They also provide support to the initial documentation of the regulatory laws that also helps in the recruitment process. In addition to this, CRA assist CRA manager for the expansion of Clinical; Monitoring Plan. Moreover, this also gives ability to work with little supervision (Poquette et al. 2005). The CRA also manages the learning parameters that include clinical study, preparation of supplies to the clinics, worksheets regarding data audit also done by the CRA. In addition to this Escudero-Ortiz et al. (2014) commented on the fact that the activities of CRA is also concerned with the evaluation as well as selection of the CROs and sites that includes CRO kick-off meetings, steering committee meetings, investigator meeting etc. They also are responsible for representing the clinical operations that are discussed in the team meetings regarding the project. According to Abubakr et al. (2010) they also are highly focused on the quality, collaboration, open communication, teamwork as well as integration. The CRAs have excellent technical skills of writing and have enough experience while working in project teams. Their interpersonal skills and excellent communication along with computer proficiency also helps them in monitoring the activities that are conducted within the organiza tion. In addition to this, Al-Sallami et al. (2010) had an opinion that the CRAs are highly flexible and integrated in their working attitude. They are quiet experienced in working with multiple teams of multiple levels, external sites as well as working in dynamic environment. According to Seger and Vogeser (2010) the CRA are very practical in their approach and they are active along with highly focused towards goals. These people are also good decision makers which they have excelled while working in a dynamic environment as well as judgmental. They work in a collaborate manner and are highly focused on team work and have an outstanding concentration in detail. In addition to this, from the viewpoint of Seger and Vogeser (2010) these people are so trained that they have the ability to work under very little supervision and work continuously for improvement of the quality. Along with this, these CRAs are highly responsible for checking the serious adverse events that results death due to long time illness or prolonged hospitalization. They sometimes are called for leading the assigned project team for Site Management (Rice, 2015). Conclusion It is seen throughout the assignment that CRAs are the people who are responsible for the conduct of the clinical activities in an overall manner. They establish as well as maintain the crucial and foremost message with the clinical sites and participate dynamically into team meetings. These CRAs play a pivotal role in developing investigators as well study staff trainings as required. 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