Associate HRPP Reg Compliance

JOB SUMMARY:
Ensures continuity and consistency of the research proposal process with some 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.
• Supports committee meetings by creating agenda templates and meeting materials, and documenting discussions.
• Prepares and distributes Committee Action or Final Approval letters under supervision.
• Manages Continuing Review notification(s) prior to expiration date of protocol.
• Accurately and completely enters data into database.
• Conducts quality assurance audits. Assists in conduct of compliance reviews and directed audits.
• Assists in developing training for committee members and the research community.
• The responsibilities listed are a general overview of the position and additional duties may be assigned.

TECHNICAL CAPABILITIES:

REGULATORY COMPLIANCE (NOVICE):- Demonstrates knowledge of the appropriate rules and regulations and apply them in difficult, stressful and complex situations. Able to interpret and explain rules and regulations that are ambiguous or unclear. Directs others in interpreting rules and regulations on the job and trains others in them.

PROBLEM SOLVING (NOVICE):- Uses critical thinking and process improvement i.e. coaches and mentors development of problem statement, describes current state, identifies root causes, creates future state, coaches and mentors development of solutions and action plans with a sustainability plan. Applies appropriate tools to address issues.

QUALITY ASSURANCE (FUNDAMENTAL ASSURANCE):- Understands the goal of increasing organizational productivity and individual performance by making the products and services within your work assignments more efficient and more effective.

CUSTOMER SERVICE (NOVICE):- A continuing focus on the needs and requirements of customers, anticipating their needs, remaining sensitive to customers while performing services for them, responsive to customer needs.

COMMUNICATION (NOVICE):- Clearly, effectively and respectfully communicates to employees or customers.

CORE ACCOUNTABILITIES:

• Organizational Impact: Delivers job responsibilities that impact own job area/team with some guidance.
• Problem Solving/ Complexity of work: Uses existing procedures, research and analysis to solve standard job related problems that may require some judgement.
• Breadth of Knowledge: Requires subject matter knowledge within a professional area to meet job requirements.
• Team Interaction: Individually contributes to project/ work teams.

Position Qualifications:
Required:
· Bachelors Diploma or GED (or equivalent experience) and <1 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

• CA

• IND000

• NHCN

• 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.
  
  
  
  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