Clinical Trials Associate II
Nephrology

JOB SUMMARY:
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.

Department Summary:

The Division of Nephrology and Hypertension at Vanderbilt University Medical Center has a long and notable history of studying the pathophysiology of and developing potential therapies for the prevention and treatment of kidney disease. With over 70 active faculty comprised of innovative, internationally recognized basic and clinical researchers and active clinicians working in state-of-the-art facilities, our contributions are validated through high-impact publications, strong federal and non-federal grant funding, and a robust clinical program that provides cutting-edge comprehensive care across the spectrum of kidney disease.

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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.

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 Adult Hospital in Tennessee and metropolitan Nashville, named to the Best Hospitals Honor Roll of the top 20 adult hospitals, 10 nationally ranked adult specialty programs, with 3 specialties rated in the top 10 nationally, Monroe Carell Jr. Children's Hospital at Vanderbilt named as one of the Best Children's Hospital in the nation, with 10 out of 10 pediatric specialties nationally ranked.

* Healthcare's Most Wired: Among the nation's 100 "most-wired" hospitals and health systems for its efforts in innovative medical technology.

* Becker's Hospital Review: named as one of the "100 Great Hospitals in America", in the roster of 100 Hospitals and Health Systems with Great Oncology Programs and to its list of the 100 Hospitals with Great Heart Programs.

* The Leapfrog Group: One of only 10 children's hospitals in the to be named at Leapfrog Top Hospital.

* American Association for the Advancement of Science: The School of Medicine has 112 elected fellows

* Magnet Recognition Program: Received our third consecutive Magnet designations.

* National Academy of Medicine: 22 members, elected by their peers in recognition of outstanding achievement

* Human Rights Campaign Healthcare Equality Index: 6 ^th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality.

KEY RESPONSIBILITIES:

• 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.
• Process Improvement
• 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.