DEPARTMENT: General Pediatric and Thoracic Surgery
SUPERVISOR'S TITLE: Clinical Research Manager, CMRSC Shared Resource Management
TITLES SUPERVISED: Specialist - Quality Assurance
TOTAL NUMBER OF FTEs DIRECTLY SUPERVISED: 0-4
TOTAL NUMBER OF FTEs INDIRECTLY SUPERVISED: 0
PURPOSE OF POSITION: To ensure quality, human subject safety and data integrity of clinical trials conducted within the assigned department; to provide project oversight and support to clinical quality assurance monitoring activities. To provide functional leadership for assigned area. To act as a leader within the division.
Develop comprehensive quality assurance plans for all clinical trial activities within the assigned department to ensure that trials are conducted in compliance with the protocol, SOPs, ICH GCP, federal, state, and local regulatory requirements. Prepare and execute quality assurance plans both internally and at affiliate sites, including site visits to ensure protocol and regulatory compliance; data management tasks to ensure study data integrity; verify essential documents are accurate, complete, and maintained; and coordination of applicable follow-up activities. Take a lead role in the development and implementation of action plans for external monitoring/audit follow-up. Develop and execute plans for preparation and conduct of audits/surveys/inspections by FDA, DHHS, institutional, and accreditation agencies. Develop improvement plans using quality improvement methods (process improvement, continuous improvement, total quality management, etc.).
Work with Clinical Research Manager to plan and execute quality assurance activities and projects. Consult with stakeholders. Identify and use appropriate project management tools and concepts (scope management, planning, budget management, risk/issue management, communications management). Provide direction and guidance to team members on execution of deliverables. Develop and execute work plan, and provide support and oversight to team members regarding work plans. Set priorities for tasks based on importance and urgency. Delegate tasks effectively.
Create work products and project deliverables, both independently and under direction of more senior-level team members. Understand and meet expectations for deliverable quality and timeliness. Oversee the creation of work products by others to ensure quality.
Provide input into the development of new protocols and plans for implementing new trials as requested by Principal Investigators/Managers. Coordinate the development of applicable sections of investigator-led protocols, e.g., data safety monitoring plans. Develop and maintain SOPs for clinical trials. Act as a primary resource on an ongoing basis for clinical trials staff, responding to questions and issues pertaining to study documentation, GCP, or other issues as requested.
Review and analyze quality assurance-related data (internal and external). Provide guidance to clinical faculty and staff in clinical research documentation for patients enrolled in clinical trials. Assist in development and monitoring of clinical trial indicators of quality, reliability, and adherence to SOPs. Develop and communicate outcome measures.
Actively contribute to a positive work environment. Serve as a resource for others. Coach and mentor team members. Assist junior resources in developing realistic project goals and monitor ongoing development (as appropriate). Provide guidance to more junior level staff and share performance feedback with manager. Collaborate effectively with others to ensure proper progress & completion of assigned work. Train new staff in all aspects of their role. Actively participate in ongoing staff development. Contribute to the professional growth of others. Assist other members by educating, providing resources & consulting on difficult work issues or projects. Indirectly (or directly) supervise lower levels.
Skills & Competencies
Experience in clinical research protocol development, data agreement execution, quality assurance, monitoring and/or auditing. Knowledge of clinical trials data management systems
Knowledge of medical terminology and anatomy
Computer literacy in MS Word, Excel, and PowerPoint; telecommunication software such as Skype, BlueJean, etc.; Data recording literacy with REDCap and EDCs
Excellent communication skills (verbal, written, and interpersonal)
Demonstrated ability to work collaboratively with diverse teams and interface effectively with research staff and investigators at multiple levels within and beyond CCHMC (i.e. for multi-site trials)
Ability to provide effective direction to others in execution of project work. Ability to effectively lead a functional work team
Experience coordinating/executing moderately complex projects
Comfortable working in a dynamic, fast-paced environment. Responsive to requests/input
Ability to develop/learn new skills
Knowledge of surgical field, preferable in pediatrics. Experience with complexity of coordinating/managing surgery related clinical trials.
Strong organizational skills and attention to detail, communication and interpersonal skills, and professionalism required
Bachelor's degree in a science or healthcare field AND 5-7 years of experience in monitoring, auditing, or other relevant research oversight activities, OR
Master's degree (MPH/Science) Quality/Process Improvement Studies AND 3 years' experience
Certification as a Clinical Research Coordinator, Clinical Research Associate, and/or Certified Clinical Research Professional, or GCP-Registered Quality Assurance Professional through the Society of Quality Assurance (or attain within 18 months of hire)
Master's degree in Science, Quality/Process Improvement Studies, Healthcare, or related field
Seven years of experience in clinical research (as described above)
SOCRA, ACRP, Project Management Professional Certification or other relevant certification
Experience with IND/IDE studies SDL2017
Cincinnati Children's Hospital Medical Center