JOB SUMMARY: Responsible for the timely preparation, planning and quality control of regulatory documents required for human subjects research. Oversees the preparation and submission of national and international applications and ongoing reports for clinical trials approvals and renewals. Collaborates with all levels of scientific, medical and technical staff to support regulatory strategies, policies and procedures. Interfaces with national and international regulatory agencies and industry sponsors in the approval of Phase I, II, III, and IV clinical studies.
The Movement Disorders division specializes in the evaluation, diagnosis, and treatment of patients with neurological disorders characterized by involuntary movements. These disorders include relatively common diagnoses such as Parkinson's disease, dystonia, spasticity, tremor, tardive dyskinesia, and Tourette syndrome as well as rarer conditions such as Huntington's disease, progressive supranuclear palsy, multiple systems atrophy (Shy-Drager Syndrome), olivopontocerebellar atrophy, corticobasal syndrome, paroxsymal dyskinesias, Wilson's disease and many others.
As one of the largest Movement Disorders divisions in the country, Vanderbilt is home to expert faculty members in all of the above conditions. With a strong commitment to improving the quality of life for their patients, faculty members in the Movement Disorders division place great emphasis on providing evidence-based care and advancing novel interventions through industry-sponsored and investigator-initiated clinical trials. Vanderbilt is a nationally recognized leader in Deep Brain Stimulation (DBS), as well as a top provider of jejunal infusions of levodopa and botulinum toxin injections. Faculty members serve as lead investigators on numerous clinical trials at any given time.
Position Shift: Day Shift/ Non-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:
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 (or equivalent experience) and 5 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.