Senior Reg Compliance Analyst (Human Research Protection Program)
JOB SUMMARY: Ensures continuity and consistency of the research proposal process independently. Facilitates the protocol process from submission to completion.
Prepares, reviews, and processes new research proposals, amendments, continuing review applications and adverse events 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.
Independently and proficiently completes and distributes Committee Action Letters and Final Approval Letters.
Independently manages Continuing Review notifications prior to expiration date of protocol.
Performs oversight and verification of database entries.
Routinely initiates and performs complex quality audits. Conducts compliance reviews and directed audits. Provides analysis of results and identifies alternatives for resolution of issues.
Leads in the 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, committee members, and the research community. Develops training for committee members and the research community.
The responsibilities listed are a general overview of the position and additional duties may be assigned
REGULATORY COMPLIANCE (ADVANCED): - 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 (ADVANCED): - 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 (ADVANCED): - 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 (ADVANCED): - 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 (ADVANCED): - Clearly, effectively and respectfully communicates to employees or customers.
CORE ACCOUNTABILITIES: Organizational Impact: Independently delivers on objectives with understanding of how they impact the results of own area/team and other related teams. Problem Solving/ Complexity of work: Utilizes multiple sources of data to analyze and resolve complex problems; may take a new perspective on existing solution. Breadth of Knowledge: Has advanced knowledge within a professional area and basic knowledge across related areas. Team Interaction: Acts as a go-to resource for colleagues with less experience; may lead small project teams.
Position Qualifications: Required: * Bachelors Diploma or GED (or equivalent experience) and 4 years relevant experience
Additional Qualification Information:
Certified IRB Professional Certification (CIP) required within the first year of employment in this position. Nursing license and/or CCRA, CCRC, CCRP or RAC certification preferred.
* 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.
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
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 t...he 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.
To improve the patient experience by providing health care providers; patients and their families; and others with information, education, networking opportunities, and related resources focused on best practices.