Clinical Research Data Specialist
The Clinical Research Data Specialist is responsible for the data management functions of the lab under occasional guidance, such that the integrity and quality of the clinical research is maintained and the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure and research protocols.
- Inputs, reviews and submits eligibility documentation into data capture systems for a portfolio of studies. Identifies and resolves any documentation discrepancies.
- Correctly and efficiently abstracts information from the EMR for multiple studies. Able to manage additional assignments as needed for fast accruing studies.
- Manages data in multiple data entry and management systems including Microsoft Access and REDCap databases.
- Efficiently solves medium to complex problems, including data cleaning / quality control, and routine data analyses under supervision of the PI.
- Submits to sponsor all pertinent data into database accurately and efficiently for clinical trials and clinical observational studies.
- Reviews and approves responses to sponsor queries from all clinical trials and observational studies. Supports complex queries and works with sponsors on issues; supports initiatives to reduce queries through identification of ongoing issue
- Uses statistical software (R, Stata, SPSS, GraphPad, etc.) and general purpose programming languages (Python, Java, etc.) to generate data summaries and analyses.
- Develops reports of results, graphs, charts, tables, etc. of analyses and presents these analyses as needed.
- Is able and willing to acquire new data management / analytical skills under the supervision and training of the PI as required.
- Works with teams and demonstrates strong communication skills.
Quality Assurance/Internal Monitoring
- Identifies data discrepancies and errors and amends or corrects data discrepancies in consultation with PIs and research team.
- Coordinates data entry, data lock, monitoring and audit deadlines for multiple studies.
- Provides supervisory responsibility to other research staff and students.
- Trains and supervises technical staff, medical and graduate students in aspects of data management, good clinical and research practices as it relates to data management as needed. Encourages input as it relates to process improvement.
- Prepares for and participates in research audits. Mentors and trains staff to prepare for and participate in internal and external audits as needed.
- Maintains open communication between department and others
The Division of Allergy, Pulmonary and Critical Care is directed by Dr. Timothy Blackwell and its mission is to:
- deliver world-class clinical care to patients with allergic diseases, pulmonary conditions, and critical illness through employing a collaborative, multi-disciplinary approach with a wide range of clinical programs.
- lead in the development of cutting-edge, patient-focused research that extends from basic discoveries to clinical implementation.
- provide state-of-the-art education and training including a strong fellowship program to inspire and nurture the next generation of leaders in allergy and immunology, pulmonary medicine, and critical care.
Work hours: Monday - Friday, Normal Daytime Business Hours
View how Vanderbilt Health employees celebrate the difference they make every day:
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: 6th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality
- Bachelor's degree (or equivalent experience) (Required)
- 3 years' experience (Required)
- No Licensure or Certification Required.
- Occasional: Sitting: Remaining in seated position
- Occasional: Standing: Remaining on one's feet without moving.
- Occasional: Walking: Moving about on foot.
- Occasional: Lifting under 35 lbs: Raising and lowering objects under 35 lbs from one level to another
- Occasional: Push/Pull: Exerting force to move objects away from or toward.
- Occasional: Bending/Stooping: Trunk bending downward and forward by bending spine at waist requiring full use of lower extremities and back muscles
- Occasional: Reaching below shoulders: Extending arms in any direction below shoulders.
- Occasional: Handling: Seizing, holding, grasping, turning or otherwise working with hand or hands.
- Occasional: Vision: Clarity of near vision at 20 inches or less and far vision at 20 feet or more with depth perception,
- peripheral vision, color vision.
- Frequent: Noise: May include exposure to occupational noise levels which equal or exceed an 8-hr time-weighted average
- of 85 decibels, requiring enrollment in VUMC's Hearing Conservation Program which includes training, use of hearing
- protection, and periodic audiometry.
- Continuous: Communication: Expressing or exchanging written/verbal/electronic information.
- Communication: Expressing or exchanging written/verbal/electronic information.
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