Research Services Consultant I

Research Services Consultant I

• 2107546

Research Services Consultant I

JOB SUMMARY:
In collaboration with the VU Human Research Protections Program, the Research Services Consultant I (RSC I) assists with the optimal application of the Federal, State, and local laws, guidance documents, VU Institutional policies, and Institutional Review Board (IRB) policies and procedures while meeting the objectives of the VU research community. Consults on research and regulatory issues to identify solutions and develop improvement processes. Certified IRB Professional Certification (CIP) and/or Certified IRB Manager (CIM) preferred. Certification may be acquired within the first year of employment. Nursing license and/or CCRA, CCRC, CCRP or RAC certification helpful.

KEY RESPONSIBILITIES:

• Serves as the central resource for the research community to provide expertise and guidance on issues, operational goals, business strategies, ethical considerations, regulatory mandates, and institutional policies related to human research protections.
• Participates in institutional activities regarding culture and regulatory issues related to research.
• Monitors and analyzes new legislation, Federal regulations, guidance documents, and program initiatives to keep abreast of current trends and changes in the research community.
• Provides expertise to departments, institutional committees, Investigators, research staff, and students on procedures and operating practices for the research community on human research protections and good clinical practices.
• Establishes and maintains communication with Investigators, research staff, representatives of professional organizations, participant advocates, and members of the public responsible for, or concerned about, protections for human participants of research.
• Collaborates with internal and external customers to develop and evaluate services for the improvement of human research protection programs.
• Advises and assists the Investigator, key study personnel, and other team members in the development of data tools, record keeping, study budgets, process improvement plans, and efficient time lines for research studies; coordinates the ongoing analysis and modification of protocols; and recommends amendments to study protocols as appropriate.
• Guides Investigators and key study personnel in the development of protocols and study budgets to capture all study costs and compliance with regulations; and assure adherence to FDA and other regulatory guidelines.
• Develops and implements training programs on the strategic application of IRB policies and procedures, Federal mandates, and guidelines, NIH, GCP/ICH guidance, and other applicable topics (e.g. budget development, research billing, grants, contracts, COI) for the VU Human Research Protections Program.
• Critically analyzes current research practices and policies through observation, data collection, peer reviews, interviews, and industry analysis to assess quality of existing workflow processes and identify improvements needed to maximize quality and efficiency of the human research protections programs.
• Analyzes cost estimates and budget requests developed for planning and projecting human research protections program activities.
• Assists with the development, implementation, and maintenance of comprehensive electronic systems including reporting to sustain efficient operations.
• Responsible for developing, implementing, and maintaining a comprehensive/strategic Continuous Quality Improvement (CQI) program for research programs within the Research Enterprise.
• Develops and implements quality assurance and regulatory plans/projects for the VU research community, programs, and departments to assure compliance with all applicable requirements; interprets regulatory requirements and recommends activities and resources required to support them.
• Defines, establishes, and assures compliance with all internal standard operating procedures consistent with Federal standards for designing, conducting, recording, and reporting research within the Research Enterprise.
• Provides ongoing assistance, consultation, and education to research personnel regarding quality assurance audits; clarifies data discrepancies and deviations from standing operating procedures.
• Assists with the design and development of audit measures based on general standard operating procedures and prepares checklists for inspections and compliance monitoring.
• Conducts internal and external audits of research at periodic intervals to identify and analyze data errors, data discrepancies, process errors, and deviations from study protocols to assure compliance with applicable regulatory requirements and standard operating procedures.
• Analyzes results and assists in the development of a preventive action plan for potential discrepancies.
• Actively demonstrates facilitative leadership to foster productive teamwork through coaching and mentoring.
• Communicates and models values and mission of VUMC.
• Exhibits personal integrity and respect for others.
• Treats all team members as unique individuals with valuable resources and skills that enhance the team.
• Collaborates with internal customers to assist in developing departmental, team, and individual goals through ongoing training and supplemental support.
• Assures self-goals are aligned with departmental goals for success.
• Accepts responsibility for improvement of one's performance through recognition of strengths and weaknesses, participation in professional development activities, and positive input in team growth.
• Actively participates in project teams to facilitate mutually acceptable solutions to conflict, questions, concerns, and implementation of new processes.
• Demonstrates a positive attitude in response to work environment stressors, problem resolution, constructive feedback, and suggestions for improvement.
• Takes responsibility for mistakes or bad decisions and learns from mistakes.
• The successful candidate must possess the following skills/characteristics: good organizational and time management skills; good oral and written communication skills; analytical and problem-solving skills; ability to multi-task; self-initiative and motivation; teamwork and facilitation skills; excellent customer service skills; and computer proficiency.

Department/Unit Summary:

Vanderbilt-Ingram Cancer Center (VICC) is a leader in the prevention, diagnosis and treatment of cancer. The centers world-renowned team of experts provides a integrated, personalized and patient-centered approach to cancer care, including treatment, research, support, education and outreach. From a wide variety of wellness programs to a leading REACH for Survivorship Clinic, patients find support from diagnosis through survivorship. VICC is a National Cancer Institute-designated Comprehensive Cancer Center, one of just two centers in Tennessee and 51 in the country to earn this highest distinction, and ranks in the top 10 nationwide for cancer research grant support. Here is a link to our website - http://www.vicc.org/

Position Shift:

• Days

View how Vanderbilt Health employees celebrate the difference they make every day:

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.

Bachelor's Degree (or equivalent experience) and 4 years experience

• Physical Requirements/Strengths needed & Physical Demands:
  Movement
  • Occasional: Sitting: Remaining in seated position
  • 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: Push/Pull: Exerting force to move objects away from or toward.
  • Occasional: Bending/Stooping: Trunk bending downward and forward by bending spine at waist requiring full use of lower extremities and back muscles
  • Occasional: Crawling:Moving about on hands and knees or hands and feet.
  • Occasional: Reaching below shoulders: Extending arms in any direction below shoulders.
  • Occasional: Handling: Seizing, holding, grasping, turning or otherwise working with hand or hands.
  
  Sensory
  • Occasional: 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.
  • Frequent: Noise: May include exposure to occupational noise levels which equal or exceed an 8-hr time-weighted average of 85 decibels, requiring enrollment in VUMC's Hearing Conservation Program which includes training, use of hearing protection, and periodic audiometry.
  • Continuous: Communication: Expressing or exchanging written/verbal/electronic information.