Manager HRPP Reg Compliance, Human Research Protection Program

Manager HRPP Reg Compliance, Human Research Protection Program - 2209361

Job : Research

Primary Location : TN-Nashville-Crystal Terrace

Organization : Human Research Protection Prog 104064

Shift: : First Shift

Description

JOB SUMMARY:

Leads the department in complex research proposals and regulatory issues to identify solutions and develop improvement processes.

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.

Position Shift:

• Full Time/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. Vanderbilts mission is to advance health and wellness through preeminent programs in patient care, education, and research.

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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. Childrens Hospital at Vanderbilt named as one of the Best Childrens Hospital in the nation, with 10 out of 10 pediatric specialties nationally ranked.

Healthcares Most Wired: Among the nations 100 most-wired hospitals and health systems for its efforts in innovative medical technology.

Beckers 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 childrens 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.

KEY RESPONSIBILITIES:

• Develops and implements projects to effectively improve and streamline operations and functions of the department.

• Defines issue management and scope management strategy. Manages on-going consensus among project team and programmers.

• Develops and communicates project documentation.

• Liaises with leadership, committees, process improvement groups, and informatics.

• Manages ongoing training, support, and implementation of necessary monitoring systems.

• Defines, establishes, audits, and assures compliance with all standard operating procedures.

• Identifies data discrepancies and determines error rates/trends.

• Analyzes cost estimates and budget requests for planning and projecting activities.

• The responsibilities listed are a general overview of the position and additional duties may be assigned.

CORE ACCOUNTABILITIES:

• Organizational Impact: Directs activities to achieve operational plans with some near term effect on results of the department/area.

• Problem Solving/ Complexity of work: Identifies issues, gathers facts to resolve technical and operational problems.

• Breadth of Knowledge: Applies in-depth knowledge and skills of a professional/technical area and basic management knowledge to manage the work of the team.

• Team Interaction: Leads a complex department with a focus on implementation. Typically executes on a short to medium term strategies.

Position Qualifications:

• Bachelor's Degree (or equivalent experience) and 5 years experience

Basic Qualifications

• Additional Qualification Information:

• Certified IRB Professional Certification (CIP) required. in this position. CCRA, CCRC, CCRP or RAC certification preferred. 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. Movement

• 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. Sensory

• 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. Environmental Conditions

Req ID: 2209361

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