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Clinical Trials Associate II (Pediatric Infectious Disease)
Discover Vanderbilt University Medical Center:
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.
Monroe Carell Jr. Children's Hospital at Vanderbilt is one of the nation's leading children's hospitals. We treat and help prevent all health issues ranging from colds and broken bones to heart disease and cancer.
The world-class facilities at Children's Hospital are a testament to our community's dedication to the health of children. Constructed in 2004 and expanded in 2012, our 271-bed hospital is a child-friendly place built on the science of healing.
A building alone does not make a great hospital. Our exceptional medical teams and the generous support of people like you enable us to provide every child who comes to us with the hope of improved health. Children's Hospital is a nonprofit facility. No child who needs our services is denied care on the basis of limited ability to pay.
Many of our doctors and surgeons are nationally recognized researchers who are finding new ways to cure and prevent childhood diseases. Their work preventing and treating premature birth, cancer, heart disease, spina bifida, and many other conditions is an investment in the future. We are at an important crossroads in child health. Our commitment to research and advocacy positions us to bring the promise of good health to children and families in our community and to share that hope with the world.
Your Role :
Supports the activities of the Principal Investigator in accordance with the protocols and regulations. Involved in the collection, interpretation and documentation of data in support of clinical trials. Conducts off-site audits. Initiates and develops process improvements. Trains and mentors new staff members.
Coordinate protocol and patient consent form process.
Coordinates preparation of all IRB and regulatory documents; under direction of PI may draft various communications with Sponsor.
Develops assessment tool pre protocol to use in clinical research.
May assist PI in obtaining Informed Consent from study participant and documents appropriately.
Identifies and recruits clinical research subjects; monitors enrollment goals and modifies recruitment strategies, as necessary.
Processes patient data and runs reports as needed.
Processes and ships lab specimens efficiently and cost effectively; maintains supply inventory and equipment; maintains regulatory standards.
Develops procedures for lab collection and storage.
May provide annual reporting to IRB and prepare annual summaries.
Abstracts and records all patient data essential to the study onto required case report forms or into the electronic data collection system.
Sets up timeline of tests and required procedures for nurse.
Inputs all pertinent patient data into database accurately.
Collects and monitors all study patient records to document treatments and outcomes as required by the protocol.
Report all adverse reactions according to VU and protocol guidelines.
Check values from lab and rates toxicity levels.
May coordinate with research investigators, monitors, IRB and sponsors regarding approval process with IRB.
Institutes process improvement measures for efficiency and productivity within the dept.
Initiates and develops new procedures to improve quality and efficiency in the dept.
Trains and mentors new staff to perform job duties at an acceptable level and understand new processes and regulations. Encourages new employees to ask questions to spur process improvement.
Pursues professional development and participate on committees, as requested by management.
Associate's Degree (or equivalent experience) and 2 years' experience
VUMC Recent Accomplishments
Because we are committed to providing the best in patient care, education and research, we are proud of our recent accomplishments:
· US News & World Report: #1 Hospital in Tennessee, #1 Health Care Provider in Nashville, #1 Audiology ( Bill Wilkerson Center ), 12 adult and 10 pediatric clinical specialties ranked among the nation's best, #15 Education and Training
· Truven Health Analytics: among the top 50 cardiovascular hospitals in the U.S.
· Becker's Hospital Review: one of the "100 Greatest Hospitals in America"
· The Leapfrog Group: grade "A" in Hospital Safety Score
· National Institutes of Health: among the top 10 grant awardees for medical research in the US
· Magnet Recognition Program: Vanderbilt nurses are the only group honored in Tennessee
· Nashville Business Journal: Middle Tennessee's healthiest employer
· American Hospital Association: among the 100 "Most Wired" medical systems in the US
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 th...e 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.