The Clinical Research Associate (CRA) assists the Clinical Affairs Team in the administration of clinical research studies. The CRA will respond to a variety of study account inquiries, issues and requests and act as a liaison between the lab and the study account. The CRA will monitor specimen TAT, set up new study accounts, manage current study accounts, requests, and track specimens, and ensure that all study specimens are adhering to the SOP. The CRA will work independently to monitor your study sites, including evaluation, initiation, routine and close out visits. The CRA will manage multiple aspects of subject's welfare, including submission of protocol, consent documents for ethics/IRB approval and assist in the preparation of regulatory submissions as requested. The CRA will monitor clinical study data for completeness and accuracy, perform data cleaning, reconciliation of data queries and generate data reports as needed. When required, the CRA will perform remote or on-site data mining in medical office EMR systems. Provide administrative support as needed to execute clinical study start up and close out duties. Provide assistance to study sites with respect to communication, study supplies, etc. Maintain close communication with the Director, Clinical Affairs, while taking initiative and working independently on assigned tasks.
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