* 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. .
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
* Day Shift/ Exempt Position
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.
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 Hospital in Tennessee, #1 Health Care Provider in Nashville, #1 Audiology ( Bill Wilkerson Center ), 9 adult and 9 pediatric clinical specialties ranked among the nation's best, #15 Education and Training
* T ruven Health Analytics: among the top 100 hospitals in the US
* Be cker's Hospital Review: one of the "100 Greatest Hospitals in America"
* The Leapfrog Group: grade "A" in Hospital Safety Score
* National Institutes of Health: among the top 10 grant awardees for medical research in the US
* Magnet Recognition Program: Vanderbilt nurses are the only group honored in Middle Tennessee
* Nashville Business Journal: Middle Tennessee's healthiest employer
* American Hospital Association: among the 100 "Most Wired" medical systems in the US
Internal Number: 1908313
About Vanderbilt Health
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 th...e 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.