Description
JOB SUMMARY:
Ensures continuity and consistency of the research proposal process under occasional guidance. Facilitates the protocol process from submission to completion.
KEY RESPONSIBILITIES:
- Prepares, reviews, and processes new research proposals, amendments, and continuing review applications prior to committee meetings.
- Prepares for and facilitates committee meetings by creating and pre-reviewing agenda templates and meeting materials, incorporating regulatory education, and documenting discussions.
- Completes and distributes Committee Action Letters and Final Approval Letters.
- Manages Continuing Review notification(s) prior to expiration date of protocol.
- Performs oversight and verification of database entries.
- Routinely initiates and performs quality audits. Assists in conduct of compliance reviews and directed audits. Provides analysis of results and identifies alternatives for resolution of issues.
- Assists with development and revision of existing policies and procedures as well as development of new policies and procedures.
- Provides training and acts as internal consultant to staff. Provides training for committee members and the research community.
- The responsibilities listed are a general overview of the position and additional duties may be assigned.
CORE ACCOUNTABILITIES:
- Organizational Impact: Executes job responsibilities with the understanding of how output would affect and impact other areas related to own job area/team with occasional guidance.
- Problem Solving/ Complexity of work: Analyzes moderately complex problems using technical experience and judgment.
- Breadth of Knowledge: Has expanded knowledge gained through experience within a professional area.
- Team Interaction: Provides informal guidance and support to team members
Position Qualifications:
Required:
* Bachelors Diploma or GED (or equivalent experience) and 2 years relevant experience
Position Shift:
* Day Shift/Exempt Position
Department/Unit Summary:
The Human Research Protection Program Mission
Protecting the safety, rights and welfare of human research participants through:
Collaboration - with Investigators, key study personnel, other supporting institutional bodies and external entities towards a common goal of protecting human research participants.
Service - guiding and supporting the development of research based on sound research design and strong ethical principles that contribute to scientific and scholarly advances in behavioral, social, biomedical and other sciences.
Developing and Implementing human research protections education programs on the application of IRB policies and procedures, and Federal regulations and guidelines.
Continuing education of Investigators and key study personnel resulting in an up-to-date and knowledgeable research community in human research protections, regulations and institutional policy and procedures.
Consulting with Investagors and key study personnel in the development of research programs to facilitate compliance with regulations, and assuring adherence to FDA and other regulatory guidelines, ethical considerations and institutional policies related to human research protections.
Administer a Community Outrearchy Program that serves the Nashville community for education on the rights of research participants.
Providing an Outreach Program for the Vanderbilt Community to educate them on the Federal regulations and human research protections.
Quality - Post Approval Monitoring of human research activities to assure compliance with Federal regulations, VHRPP and institutional policies and procedures.
Supporting a continuous quality improvement program through continuous assessment, evaluation and action.
Click Here To View The VUMC Promise of Discovery
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.
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 ), 9 adult and 9 pediatric clinical specialties ranked among the nation's best, #15 Education and Training
* Truven Health Analytics: among the top 100 hospitals in the US
* 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
* American Association for the Advancement of Science: 12 faculty members elected fellows in 2014
* 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
