In your pivotal role as Sr. Research Regulatory Affairs Manager, you will serve as the central resource to investigators to assist and provide guidance regarding Investigational New Drug (IND) development through experience with and knowledge of related federal regulations (FDA). You will work closely and partner with investigators and internal departments to deliver safe and effective research designs for clinical trials in line with institutional policies and procedures and federal regulations. You will provide quality assurance support with focus on compliance with methods, facilities and controls as they relate to federal regulations. In this role you will serve as a resource to investigators to assist and provide guidance and education regarding device development through experience with and knowledge of related federal regulations.
* PhD preferred
* 3-4 years' experience working in clinical drug trial research
* 1 year experience working with IND
Strong project planning, strategy, leadership, negotiation and presentation skills as well as an ability to contribute creatively and practically to resolve problems and capitalize on opportunities.
Experience in developing an IND strategy and amendments
Ability to standardize consulting practices across multiple regions in order to streamline efficiencies and improve overall delivery of service while maintaining the highest standards in regulatory compliance.
Ability to establish and maintain relationships with sponsoring companies, investigators and institutional research units to optimize the performance of research activities while managing the activities of investigative sites across multiple protocols and multiple areas.
1. Utilize knowledge of the federal regulations and institutional procedures to accurately and effectively assist Investigators and the Institution in assuring the quality of FDA regulated Investigational New Drugs (IND).
a. Advise investigators on preclinical and regulatory pathway most appropriate for specific IND development and with developing FDA applications and protocols.
b. Assist investigators in determining types of regulatory submissions or internal documentation required in diverse situations and coordinate, prepare and review regulatory submissions/documents to the appropriate regulatory body.
c. Actively support researchers in communications with the FDA by scheduling meetings and preparing and submitting communications per regulations.
d. Identify and assist with interpretation of relevant regulations, guidance documents, and consensus standards.
e. Develop or conduct regulatory training for staff and investigators.
2. Utilize strong working knowledge of the federal regulations to assist Investigators in the development and management of an effective quality assurance process to support compliance with federal regulations for methods, facilities, and controls.
a. Review the program, on a continuous basis, to determine which areas need improvement and implement the necessary changes using the Continuous Quality Improvement (CQI) approach.
b. Assist in the development and management of standard operating procedures as well as other documentation according to all applicable regulations.
c. Develop and/or tracks quality metrics.
d. Collaborate with other institutional individuals assisting Investigators in research activities as needed.
e. Collaborate with other institutional departments (e.g., VHRPP, Risk Management, Contracts Management, Department of Finance, and the Office of Sponsored Programs).
3. Responsible for maintaining an effective IND quality assurance program.
a. Compile and maintain regulatory documentation databases or systems.
b. Review and oversee adverse events, protocol deviations, and unanticipated problems to ensure appropriate and timely reporting.
c. Write or update standard operating procedures, work instructions, or policies.
d. Collaborate with Research Support Services and the CTSA to develop best practices which can be applied across the consortium.
e. Recommend changes to institutional procedures in response to changes in regulations or standards.
f. Coordinate ongoing training and support for investigators and research staff, and coordinates and/or implements internal auditing systems that are necessary.
4. Actively identify and participate in educational and developmental activities to improve knowledge and performance to sustain and enhance personal and program development.
a. Actively work to correct errors, regardless of the cause by conducting internal audits of department procedures.
b. Act independently; accomplish goals without direct management supervision.
5. Actively demonstrate facilitative leadership to foster productive teamwork through coaching and mentoring.
a. Collaborate with internal customers to assist in developing departmental, team, and individual goals through ongoing training and supplemental support.
b. Actively participate in project teams to facilitate mutually acceptable solutions to conflict, questions, concerns, and implementation of new processes.
c. Create an environment that encourages and supports self-development and learning for all staff through regular feedback by assuring the development of staff through orientation, training programs, work experiences and assessing competencies.
About the Department:
The mission of the Vanderbilt Institute for Clinical and Translational Research (VICTR) , which is of strategic importance to our institution and its research operation, is to remove impediments to translational science so that innovations reach the people who need them more quickly. We are a workforce united not only by common purpose but also by common values.
In collaboration with the VUMC Human Research Protections Program (HRPP), the Translational Research Navigator II assists with the optimal application of the Federal, State, and local laws, guidance documents, VUMC Institutional policies, and Institutional Review Board (IRB) policies and procedures while meeting the objectives of the VUMC research community. Consults on complex research and regulatory issues in conjunction with the team(s) to identify solutions and develop improvement processes. The TRN II researches topics of departmental, institutional or strategic importance.
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 Hospital 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
* Truven Health Analytics: among the top 50 cardiovascular hospitals in the U.S.
* Becker'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: 1901916
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.