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. This role may serve as lead on observational clinical trials.
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 perform study consent and enrollment activities.
Gathers complete medical history of patient.
Monitors patient consent forms are completed correctly.
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
Serves as lead staff on observational studies.
Develops tools for accurate study execution.
Able to work independently start up and close out procedures with someone on call for back up.
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.
Communicates applicable protocol specific information to the rest of the team and investigators.
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.
Set up tools and kits to aid follow up and protocol compliance.
Examine data and records to ensure compliance with protocol.
Trains staff on new procedures, orientation and protocol execution.
Monitors follow up visits for protocol compliance.
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.
This is a full-time position; variable 2nd and 3rd shifts and weekend rotations.
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Salary is dependent upon education and experience.
Background screens will be performed and education will be verified prior to employment. Please be prepared to provide required information and/or documentation.
Vanderbilt University Medical Center is home to Vanderbilt University Hospital, The Monroe Carell Jr. Children’s Hospital at Vanderbilt, the Vanderbilt Psychiatric Hospital and the Vanderbilt Stallworth Rehabilitation Hospital. These hospitals experienced more than 61,000 inpatient admissions during fiscal year 2015. Vanderbilt’s adult and pediatric clinics treated nearly 2 million patients during this same period. Vanderbilt University Hospital and the Monroe Carell Jr. Children’s Hospital at Vanderbilt are recognized again this year by U.S. News & World Report’s Best Hospitals as among the nation’s best with 18 nationally ranked specialties. Vanderbilt University Medical Center is world renowned because of the innovation, work ethic and collegiality of its employees. From our health care advances to our compassionate care, Vanderbilt owes its accomplishments and reputation to staff and faculty who bring skill and drive and innovation to the medical center day after day. World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.As t...he largest employer in middle Tennessee, we welcome those who are interested in ongoing development in a caring, culturally sensitive and professional atmosphere. Most of us spend so much of our lives at work, we want to be part of maintaining a workplace in which people support one another and encourage reaching for excellence. Many high-achieving employees stay at Vanderbilt because of the professional growth they experience and because of their appreciation of Vanderbilt’s benefits, public events and discussions, athletic opportunities, beautiful setting and, above all, sense of community and purpose.Vanderbilt and its employees share a set of mutual expectations that have been created with productivity, legality, fairness and safety always in mind. We believe that our investment in training and compensating employees multiplies in value when we enable individuals to deliver their best performance for the benefit of us all.