Ensures continuity and consistency of the research proposal process under occasional guidance. Facilitates the protocol process from submission to completion.
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.
· Day Shift/ Exempt Position
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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 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: 6th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality.
Additional Key Elements/ 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
- 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.
Bachelor's Degree (or equivalent experience) and 2 years experience
- Additional Qualification Information:
- Required to pass the HRPP training and orientation program within 6 months of employment.
Physical Requirements/Strengths needed & Physical Demands:
- Sedentary category requiring exertion up to 10 lbs. of force occasionally and uses negligible amounts of force to move objects. Sedentary work involves sitting most of the time.
- Occasional: Standing: Remaining on one's feet without moving.
- Occasional: Walking: Moving about on foot.
- Occasional: Lifting under 35 lbs: Raising and lowering objects under 35 lbs from one level to another
- Occasional: Carrying under 35 lbs: Transporting an object holding in hands, arms or shoulders, with help of coworkers or assistive device.
- Occasional: Push/Pull: Exerting force to move objects away from or toward.
- Occasional: Reaching above shoulders: Extending arms in any direction above shoulders.
- Frequent: Reaching below shoulders: Extending arms in any direction below shoulders.
- Frequent: Bimanual Dexterity: Requiring the use of both hands.
- Continuous: Sitting: Remaining in seated position
- Continuous: Fingering: Picking, pinching, gripping, working primarily with fingers requiring fine manipulation.
- Continuous: Communication: Expressing or exchanging written/verbal/electronic information.
- Continuous: Auditory: Perceiving the variances of sounds, tones and pitches and able to focus on single source of auditory information
- Continuous: Vision: Clarity of near vision at 20 inches or less and far vision at 20 feet or more with depth perception, peripheral vision, color vision.
- Continuous: Feeling: Ability to perceive size, shape, temperature, texture by touch with fingertips.
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