Clinical Trials Associate I - Nephrology

Clinical Trials Associate I - Nephrology

This is a Term position which will last approximately 6-12 months.

The Clinical Trials Associate I performs a variety of duties involved in the collection, interpretation, and documentation of data in support of clinical trials. This person will perform collection, interpretation and documentation of data for the GUARDD Clinical Trials Project.

Work Schedule:
Flexible Schedule project period - Up to one year.

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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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.

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• 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: 6th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality.

Key Responsibilities:

• Assists nurse 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 nurse.
• 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 for nurse.
• 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 nurse and Clinical Trials Specialist with monitoring compliance with protocol and regulations
• Ensures deadlines are met for study
• Informs nurse 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, gives to nurse with specific times and dates for collection.
• Freezes, spins, separates samples, and cultures as necessary. Mails to designated labs.
• 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.
• Conducts follow-up of study patients.
• Calls or sends questionnaires to patient to check outcomes, survival rate, and quality of life.
• Informs tumor registry, appropriate clinics, and hospital of patient status.
• May conduct outside audits of other institutions data.
• Knowledgeable of protocol

A Term position is a staff position that exists for a period longer than six months but is not expected to last beyond one year. Although a position may exist for a specified or indefinite period, staff who accept term positions are not guaranteed employment for the entire period; they are employed for indefinite periods within the limit of the appointment. There are no guarantees of continued employment, either within the term or when the term ends.

Requires an Associate's Degree (or equivalent experience) and 1 year of experience (or equivalent education may be substituted).