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Clinical Trials Associate I
Vanderbilt Health
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Clinical Trials Associate I

Vanderbilt Health

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Details
Posted:
February 12, 2019
Location:
Nashville, Tennessee
Salary:
Open
Description
 
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.
 


JOB SUMMARY:
Performs a variety of duties involved in the collection, interpretation, and documentation of data in support of clinical trials. Assists in ensuring adherence to protocols, appropriate regulations, and deadlines. Ensures quality of information received.


KEY RESPONSIBILITIES:

  •  1. Assists nurse, program coordinator or principal investigator in assessing patient eligibility for approved study. 

    1a. Knowledgeable of protocols in order to determine specific criteria for eligibility or exclusion.  

    1b. Gathers complete medical history of patient.   

    1c. Ensures patient consent forms are completed.  

    1d. Reviews medical history to determine eligibility status  

    1e. Discusses findings with research nurse or other study personnel. 

    2. Processes patient data and runs reports as needed. 

    2a. Abstracts and records all patient data essential to the study onto required case report or survey forms. 

    2b. Sets up timeline of tests and required procedures for nurse, coordinator or principal investigator.  

    2c. Inputs all pertinent patient data into database accurately  

    2d. Collects and monitors all study patients records to document treatments and outcomes as required by the protocol  

    2e. Reports all adverse reactions according to VU/VUMC and protocol guidelines  

    2f. Checks values from lab and rates toxicity levels  

    2g. Ensures complete source documentation in record  

    2h. Ensures treatment and dates match  

    2i. Assists nurse, program coordinator, principal investigator and/or Clinical Trials Specialist with monitoring compliance with protocol and regulations  A40:C54

    3. Ensures deadlines are met for study 

    3a. Informs nurse, coordinator or principal investigator of tests and procedures as needed  

    3b. Schedules shipping of specimens and samples to meet protocol deadlines.  

    3c. Coordinates with patient's other health care providers or testing facility to ensure tests or procedures are conducted as required.  

    3d. Prepares kits for procedures, labels tubes, gives to nurse, coordinator or principal investigator with specific times and dates for collection.  

    3e. 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. 

    4a. Meets with and assists in response to sponsors and monitors to ensure compliance with protocol and applicable regulations.  

    4b. Answers queries from sponsoring companies. 

    4c. Meets with monitors to respond to any question of data validity. 

    5. Conducts follow-up of study patients. 

    5a. Calls or sends questionnaires to patient to check outcomes, survival rate, and quality of life.  

    5b. Informs tumor registry, appropriate clinics, and hospital of patient status. 

    6. May conduct outside audits of other institutions data.

    6a. Knowledgeable of protocol  

    6b. Examine data and records to ensure compliance with protocol. 

    *Other duties as assigned by Lab Manager, program coordinator and PI*

 

        

 

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
 

                                                                                                                                                                   

 

Internal Number: 1806516
About Vanderbilt Health
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.
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