Clinical Research Data Spec, VUMC Sickle Cell Disease Ctr
Location: Nashville, Tennessee
Academic / Research
Internal Number: 2110020
Clinical Research Data Specialist - PEDS VUMC SICKLE CELL CENTER
The purpose of this position is to manage the data and research governance for the Vanderbilt Global Haploidentical Consortium and the research governance for the adult stroke Nigerian study in sickle cell disease and priapism, along with the obstetric project to prevent maternal deaths in women with sickle cell disease. The activities will include, but is not limited to, collection of source documentation from outside sites, verification of eligibility of patients prior to enrollment on a study, management of patient slot availability, monitoring entry into the electronic database and verification against submitted source documentation, querying for resolution to any discrepancy of data entered or submitted, training of sites on study specific procedures and expectations, etc.
The Vanderbilt-Meharry Center of Excellence in Sickle Cell Disease features experts from many medical fields to provide you help and healing. Our pediatric and adult sickle cell specialists offer you care based on research and experience. We treat your symptoms and determine if you are a candidate for therapies that can lead to a cure. We are connected to everything Vanderbilt offers. This means we can help you face life with sickle cell disease from every angle - with medical, mental and social support.
Day Shift/Exempt Position
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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.
Additional Key Elements/ Responsibilities:
DETAILED DESCRIPTION BASED ON DAY-TO-DAY ACTIVITIES
Knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates them in securing approval for and the conduct of research
Must know policies, procedures, and regulations to know when a patient can/cannot be enrolled on a study
Knowledge of requirements regarding reporting of protocol non-compliance, adverse events, and serious adverse events
Knowledge and understanding of the implementation, coordination, management and reporting of clinical/translational research operations
Must understand the protocol and procedures to submit, review, and seek approval of protocol and protocol related documents
Must be able to review protocols and assist in the development of source documentation to capture data time points needed to obtain objectives of the protocol
Train internal and external research staff on protocol and trial expectations as needed
Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants
Will work with internal and external research staff on protocol expectations
Reporting guidelines, elevate issues to PI of trial, FDA, and other governing bodies as needed to ensure human subjects protection
Actively identifies and participates in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Pursues avenues to ensure awareness of the latest information available to coordinators conducting clinical/translational research (i.e., literature searchers, research seminars, in-services, etc.)
Engages in a minimum of 10 hours of continuous, job-related educational activities annually
Actively seeks new learning opportunities, seeing learning as a part of work
Bachelor's Degree (or equivalent experience) and 3 years experience
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.
To improve the patient experience by providing health care providers; patients and their families; and others with information, education, networking opportunities, and related resources focused on best practices.