Sr Clinical Trials Specialist (Pediatric VaccineResearch Program)
Discover Vanderbilt University MedicalCenter:
Locatedin Nashville, Tennessee, and operating at a global crossroads of teaching,discovery and patient care, VUMC is a community of individuals whocome to work each day with the simple aim of changing the world. It is a placewhere your expertise will be valued, your knowledge expanded and your abilitieschallenged. It is a place where your diversity â of culture, thinking, learningand leading â is sought and celebrated. It is a place where employees know theyare part of something that is bigger than themselves, take exceptional pride intheir work and never settle for what was good enough yesterday. Vanderbiltâs mission is to advancehealth and wellness through preeminent programs in patient care, education, andresearch.
MonroeCarell Jr. Children's Hospital at Vanderbilt is one of the nation's leadingchildren's hospitals. We treat and help prevent all health issues ranging fromcolds and broken bones to heart disease and cancer.
The world-class facilities atChildren's Hospital are a testament to our community's dedication to the healthof children. Constructed in 2004 and expanded in 2012, our 271-bed hospital isa child-friendly place built on the science of healing.
A building alone does not make a greathospital. Our exceptional medical teams and the generous support of people likeyou enable us to provide every child who comes to us with the hope of improvedhealth. Children's Hospital is a nonprofit facility. No child who needs ourservices is denied care on the basis of limited ability to pay.
Many of our doctors and surgeons arenationally recognized researchers who are finding new ways to cure and preventchildhood diseases. Their work preventing and treating premature birth, cancer,heart disease, spina bifida, and many other conditions is an investment in thefuture. We are at an important crossroads in child health. Our commitment toresearch and advocacy positions us to bring the promise of good health tochildren and families in our community and to share that hope with the world.
Responsiblefor the timely preparation, planning and quality control of regulatorydocuments required for human subjects research. Oversees the preparation andsubmission of national and international applications and ongoing reports forclinical trials approvals and renewals. Collaborates with all levels ofscientific, medical and technical staff to support regulatory strategies,policies and procedures. Interfaces with national and international regulatoryagencies and industry sponsors in the approval of Phase I, II, III, and IVclinical studies.
Regulatory affairs management of clinical research activities.
Establishes working relationships with investigators and research staff to facilitate communication and participation in research start-up procedures.
Works as a part of a project team in the development and design of applications for support of clinical trials.
Supplies regulatory assistance for the successful conduct of biologic, drug, and device clinical trials using human subjects.
Interfaces with federal agencies and industry sponsors in the approval of Phase I, II, III, IV clinical research studies.
Participates and provides input in interdepartmental, industry, and international project teams as the regulatory representative interpreting and applying regulations, guidelines, research/information available, and policies to enable the team to select the most effective start up.
Submits Informed Consent, Human Subjects' Research Applications, DSMB, HIPAA compliance, Radiation and Biosafety, and other pertinent regulatory forms to the IRB for institution approval of clinical trials.
Manages complex multiple project regulatory obligations and timeline restrictions.
Completes and coordinates regulatory documentation for Investigational New Drug and Biologic License Applications.
Communicates directly with FDA to provide input into new and/or ongoing clinical research programs.
Establishes and maintains regulatory information and database systems both electronically and hardcopy.
Assists with protocol development of investigator-initiated research.
Training and Staff Development
Communicates appropriate institutional and regulatory guidelines to faculty and staff.
Creates SOPs for division consistency and provides regulatory consulting expertise to study team members.
Identifies deficiencies and discrepancies in regulatory processes and provides staff training as needed
Performs random, for-cause, and regulatory committee-requested audits of research studies as appropriate to ensure compliance with applicable regulations and guidelines.
Quality Control Improvement and Continuing Education
Identifies potential for functional improvements in clinical research to meet changing regulatory and business environments.
Maintains current working knowledge of federal, state, local, and institutional regulatory guidelines.
Pursues professional development opportunities, including external and internal training.
Attends regional or national industry/professional meetings, conferences, and workshops.
Bachelor's Degree (orequivalent experience) and 5 years experience
VUMC Recent Accomplishments
Becausewe are committed to providing the best in patient care, education and research,we are proud of our recent accomplishments:
Â·US News & World Report: #1Hospital 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
Â·Truven Health Analytics: amongthe top 50 cardiovascular hospitals in the U.S.
Â·Becker's Hospital Review: oneof the "100 Greatest Hospitals in America"
Â·The Leapfrog Group: grade"A" in Hospital Safety Score
Â·National Institutes of Health: amongthe top 10 grant awardees for medical research in the US
Â·Magnet Recognition Program: Vanderbiltnurses are the only group honored in Tennessee
Â·Nashville Business Journal: MiddleTennessee's healthiest employer
Â·American Hospital Association: amongthe 100 "Most Wired" medical systems in the US
Vanderbilt University Medical Center is a comprehensive health care facility dedicated to patient care, research, and biomedical education. Our reputation for excellence in these areas has made us a major center for patient referrals from throughout the Mid-South. Each year, people throughout Tennessee and the Southeast choose Vanderbilt University Medical Center for their health care because of our leadership in medical science and our dedication to treating patients with dignity and compassion.The mission of Vanderbilt University Medical Center is to advance health and wellness through preeminent programs in patient care, education, and research.