Vanderbilt University Medical Center Clinical Research Quality Consultant in Nashville, Tennessee

Job Summary

The Clinical Research Quality Consultant (CRQC) serves as an internal advisor across all divisions of the Vanderbilt Coordinating Center (VCC), housed within the Vanderbilt Institute for Clinical and Translational Research (VICTR). The CRQC’s primary focus will be identifying opportunities to improve the quality of work performed by VCC staff while simultaneously implementing corrective action plans to ensure continued compliance and success of VCC programs. The CRQC will work to establish and inform best practices within the VCC as a member of the “ACE” (Auditing, Compliance, and Education) program. In an effort to connect these multiple missions of auditing, compliance and education, the CRQC will work with VCC leadership to implement and improve policies, processes, and procedures that compose the ACE program. The CRQC will serve as a critical link to ensuring that the VCC continues to be founded on unparalleled quality standards.

PreferredSkills, Qualifications, And Certifications

· Experience with database design and management

· Microsoft Excel experience with data analysis, and data visualization

· Experience with presentation development and speaking for broad clinical research audiences

· Experience with project management at large rapid pace organizations

· Applicable certifications/licenses: Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), or Certified Clinical Research Coordinator (CCRC)

Ideal Skills,Qualifications, And Certifications

· National clinical trial project management with experience overseeing participating research sites contributing to a prospective, multicenter clinical trial

· Experience with multi-site investigator-initiated and pharmaceutical industry sponsored trials

· Regulatory oversight of national clinical trial sites

· First-hand experience with research subject recruitment, enrollment, data collection, and assurance of protocol compliance for diverse therapeutic areas

· First-hand experience with various types of IRB submissions

· Possible certifications/licenses: Certified Project Management Professional (PMP), Registered Nurse (RN), or Regulatory Affairs Certification (RAC)

KeyResponsibilities

General

· Serves as a resource for VCC staff to provide expertise and guidance on complex issues, operational goals, integration of technical solutions, ethical considerations, external regulatory mandates, and institutional policies related to human subjects research.

· Develop, implement, and maintain comprehensive, strategic, and Continuous Quality Improvement Initiatives (CQI2’s) for research processes within the VCC.

· Conducts quality oversight of all study activities and provides risk mitigation strategies and process improvement feedback to project leaders and senior management. Facilitates problem resolution and issue escalation in partnership with VCC management.

· Serves as a liaison to the research informatics team to identify opportunities to increase efficiencies in electronic processes and systems. Provides valuable feedback regarding optimal informatics solutions, tests solutions, and when applicable, implements simple informatics solutions.

· Perform root cause analysis to identify source of problems or non-conformances.

· Promotes recognition of quality programs among internal and external colleagues and collaborators.

· Monitors and reports developments regarding Federal, State, and local laws, and research enterprise policies and procedures that impact VCC initiatives.

· Establishes and maintains communications with institutional committees, 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.

Auditing

· Supports the QA auditing process for assessing and assigning a level of risk for new clinical trials in order to ensure ongoing compliance is properly addressed according to a set of pre-determined standards. Helps maintain consistent auditing at set intervals through the development of electronic systems and reports.

· Conducts all types of audits (protocol compliance, financial, database systems, regulatory, etc.), as dictated by QA Leadership. Carries out auditing of study, project, and process reports, records and data; presents audit findings to operations via QA audit reports; and determines acceptability of the responses and verifies the corrections are sufficient. Ensures all assigned audits are performed on a quarterly basis, supporting team members with audits as needed.

· Analyzes and proposes ongoing best practices for implementing and conducting audits and investigations. Designs and develops audit measures based on general standard operating procedures and prepares electronic checklists for inspections and compliance monitoring.

· Serves as a resource during FDA inspections and participates in inspection readiness plans and activities. Assists with the planning and management of sponsor audits and third party vendors (including CROs, pharmacy, technology vendors, and laboratories).

· Participates in external sponsor audits by serving as a primary liaison, communicating VCC and Vanderbilt policy and procedure. Identifies quality issues across audits by developing standardized assessment tools, including sponsor-centered surveys capturing the sponsor’s opinion on the quality of work performed for their trial(s). Acts as an intermediary amongst sponsors, managers, and research coordinators and nurses in order to prevent and solve issues identified during external sponsor audits.

· Reviews study events, deviations, investigations, and change control documentation; and assesses acceptability of the content and documentation. Confirms clinical trial study reports against source data for data accuracy, integrity and consistency.

· Provides ongoing assistance, consultation, and education to research personnel regarding QA audits; clarifies data discrepancies and deviations from standard operating procedures. Analyzes results and assists in the development of a corrective action plan, likely involving process improvement, policy change, and targeted education, in order to prevent future discrepancies.

· Works with QA leadership to provide feedback and identify deficiencies and common trends in QA audits to ensure timely and effective change control. Collaborates with Principal Investigators and Research Teams on audit findings, corrective action and preventive plans.

Compliance

· Serves as the primary point of contact for VCC clinical research policies. With support from leadership, develops, updates, and maintains policies in an electronic environment and serves as a liaison to all VCC staff when policy interpretation and identification is required.

· Defines, establishes, and assures compliance with all internal standard operating procedures. Confirms consistency of VCC policies with Federal, State, local, and Institutional regulations.

· Serves as a lead for establishing policy working groups, with input and support from leadership, in order to provide content and expertise when developing, updating, and/or confirming processes and regulations outlined within VCC policies. Ensures working groups meet deliverables, members provide content as required, and manages working group timelines when applicable.

· Provides input on the development, implementation, and maintenance of comprehensive electronic systems, often through the use of REDCap databases (including development and oversight of reporting within those systems) in order to sustain and enhance operational efficiencies.

· Interfaces and partners with regulatory bodies who influence policies and regulations that affect research.

Education

· Works closely with the VCC’s Clinical Research Educator to identify gaps in educational knowledge across the VCC. Relays to leadership opportunities and needs for additional education once identified through internal auditing and QA reporting.

· Assists with the development of tailored educational materials along with creating processes for assessing competencies once new educational materials and/or programs are presented to VCC staff. May serve on educational focused working groups in order to design and ensure the successful implementation of educational materials.

· Assists with the development of initial orientation and ongoing training materials for VCC staff and tailors materials to specific job descriptions and varying levels of expertise found within the VCC.

· Researches, analyzes, and recommends external and internal training programs for VCC staff.

· Provides expertise to departments, institutional committees, Investigators, and research staff on procedures and operating practices for the research community based on human research protections regulations and good clinical practices.

ProfessionalAnd Interpersonal Skills

· Actively demonstrates facilitative leadership to foster productive teamwork through coaching and mentoring.

· 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.

· Demonstrates a positive attitude in response to work environment stressors, problem resolution, constructive feedback, and suggestions for improvement.

· Effectively participates and leads project teams to facilitate mutually acceptable solutions to conflict, questions, concerns, and implementation of new processes.

· 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.

· Takes responsibility for mistakes or bad decisions and learns from mistakes.

VICTR VCC

Bachelor's Degree (or equivalent experience) and 6 years relevant 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.

Job Research

Organization: VICTR Vanderbilt Coord Center 104241

Title: Clinical Research Quality Consultant

Location: TN-Nashville-2525 West End Ave

Requisition ID: 1803983