Clinical Trials Associate I
Job Summary : This position will provide varied support for clinical trials and research projects within the Emergency Medicine Research Division reporting to the Director of Clinical Research Operations. This research position will perform a variety of duties involved in the collection, processing, interpretation, storage and documentation of biological and data specimens in support of clinical trials. The role is expected to assist research faculty and staff in ensuring adherence to protocols, appropriate regulations, deadline and quality of information received. Key functions and expected performances include but are not limited to the following: 1. Assists research coordinators and lead staff in assessing patient eligibility for approved study. * Knowledgeable of protocols in order to determine specific criteria for eligibility or exclusion. * Gathers complete medical history of patient. * Ensures patient consent forms are completed. * Reviews medical history to determine eligibility status * Discusses findings with research coordinators and lead staff. 2. Processes patient data and runs reports as needed. * Abstracts and records all patient data essential to the study onto required case report forms. * Sets up timeline of tests and required procedures according to the protocol. * Inputs all pertinent patient data into database accurately * Collects and monitors all study patients records to document treatments and outcomes as required by the protocol * Reports all adverse reactions according to VU and protocol guidelines * Checks values from lab and rates toxicity levels * Ensures complete source documentation in record * Ensures treatment and dates match * Assists clinical research coordinators and lead staff with monitoring compliance with protocol and regulations 3. Ensures deadlines are met for study * Informs research coordinators and lead staff of tests and procedures as needed * Schedules shipping of specimens and samples to meet protocol deadlines. * Coordinates with patient's PCP or testing facility to ensure tests or procedures are conducted as required. * Prepares kits for procedures, labels tubes, according to each study with specific times and dates for collection. * Freezes, spins, separates samples, and cultures as necessary. Mails to designated labs. 4. Meets with and assists in response to sponsors and monitors to ensure compliance with protocol and applicable regulations. * Meets with and assists in response to sponsors and monitors to ensure compliance with protocol and applicable regulations. * Answers queries from sponsoring companies. * Meets with monitors to respond to any question of data validity. 5. Conducts follow-up of study patients. * Calls or sends questionnaires to patient to check outcomes, survival rate, and quality of life. * Informs appropriate registry, clinics, and research coordinators of patient status. * May conduct outside audits of other institutions data. * Knowledgeable of protocol. * Examine data and records to ensure compliance with protocol.
Department/Unit Summary :
Vanderbilt University Medical Center's Department of Emergency Medicine is a national leader in emergency care research. Led by 8 core faculty and an extensive research infrastructure, we are top leaders in designing innovative ED-based research and are top enrollers in both industry and federally funded studies. Our research staff actively screens patients over 100 hours each week in the emergency departments at VUMC and the Tennessee Valley Hospital. Combined, these Eds see over 100,000 patients each year. To ensure timely enrollment in therapeutic studies, the research faculty are immediately available to assist the student team on a daily basis. For more information, please visit https://vanderbiltem.com/em-research
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Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. It is a place where your diversity -- of culture, thinking, learning and leading -- is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt's mission is to advance health and wellness through preeminent programs in patient care, education, and research.
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