Clinical Research Data Specialist, Vaccine Research Program

JOB SUMMARY:This position is responsible for the data management functions and conduct of research protocols, 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.Department/Unit Summary:The Vanderbilt Vaccine Research Program was formed in 2001 to conduct clinical and translational research in vaccines, vaccine preventable diseases, and pediatric infectious diseases. Led since 2014 by Dr. Buddy Creech, Associate Professor of Pediatric Infectious Diseases, the mission of the VVRP is to reduce the burden of infectious diseases worldwide through the discovery, evaluation, and delivery of effective and safe vaccines and therapeutics.Our vision is that tomorrow will be better than today .Position Shift:· Day Shift/ Exempt PositionClick here to view how Vanderbilt Health employees celebrate the difference they make every day:Celebrate 2019Click Here To View The VUMC Promise of DiscoveryOur Nursing Philosophy:We believe highly skilled and specialized nursing care is essential to Vanderbilt University Medical Center’s mission of quality in patient care, education and research. We believe nursing is an applied art and science focused on helping people, families and communities reach excellent health and well-being.Achieve the Remarkable:Learn more about VUMC Nursing:· Nursing Careers : http://www.vumcnursingcareers.com/index.html· Benefits : http://www.vumcnursingcareers.com/benefits.html· Our Nursing Philosophy : http://www.vumcnursingcareers.com/philosophy.html· Our Nursing Leadership : http://www.vumcnursingcareers.com/leadership.html· Shared Governance : http://www.vumcnursingcareers.com/shared-governance.html· Education & Professional Development : http://www.vumcnursingcareers.com/professional-development.html· Life In Nashville : http://www.vumcnursingcareers.com/nashville.htmlVUMC Nursing : http://www.mc.vanderbilt.edu/root/vumc.php?site=vanderbilt-nursingVUMC Recent AccomplishmentsBecause 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:KEY RESPONSIBILITIES:Data Management

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.

Identifies AEs from EMR, provides support to correctly and completely record AEs and serves as resource to CTA II staff. Assists with trending reports on AEs for each trial and across teams.

Submits to sponsor all pertinent data into database accurately and efficiently for Phase I/II/III trials. Acts as preceptor for CTA II staff.

Reviews and approves responses to sponsor queries from CTA IIs. Supports complex queries and works with sponsors on issues; supports initiatives to reduce queries through identification on ongoing issue

External Sponsor Monitoring and Visit Management

Coordinates monitor scheduling for multiple studies, including fast accruing studies with increased monitoring demand and studies with data locks for FDA submissions and/or national meeting presentations.

Meets with monitors to review data monitoring results, answer questions and resolve queries. Demonstrates effective communication with external monitors. Mentors data team on resolving issues.

Quality Assurance/Internal Monitoring

Queries research team to clarify, reconcile and complete data issues. Develops assessment tools to assist clinical staff during patient visits. Mentors and trains CTA II staff to communicate effectively with the research team as needed.

Identifies and resolves discrepancies with research team. Mentors and assists data team in effective discrepancy resolution as needed.

Coordinates data entry, data lock, monitoring and audit deadlines for multiple studies.

Trains CTA II staff in 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 clinical trial audits. Mentors and trains CTA II staff to prepare for and participate in internal and external audits as needed.

Position Qualifications:Bachelors Diploma (or equivalent experience) and 3 years experience required.CAIND000NHCNPhysical Requirements/Strengths needed & Physical Demands:MovementOccasional: 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.

SensoryOccasional: 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.

Environmental ConditionsJob ResearchOrganization: Vaccine Research Program 104568Title: Clinical Research Data Specialist, Vaccine Research ProgramLocation: TN-Nashville-Medical Center North (MCN)Requisition ID: 2010056Vanderbilt University Medical Center is committed to principles of equal opportunity and affirmative action.