Senior Specialist-Clinical Research Quality Assurance (Clinical Trial Monitoring) - Office for Clinical and Translational Research

DEPARTMENT: Office for Clinical and Translational Research

SUPERVISOR'S TITLE: Regulatory Affairs Manager

TITLES SUPERVISED: Specialist - Quality Assurance



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.

·Quality Assurance Monitoring
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.).
·Quality Assurance Oversight & Management
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.
·Project Execution
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.
·Clinical Trial Protocol Development and Implementation
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.
·Data and Documentation
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.
·Mentor and Develop
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
·Clinical Research
Experience in clinical research quality assurance, monitoring and/or auditing. Knowledge of clinical trials data management systems
·Medical terminology - basic
Knowledge of medical terminology and anatomy
·Computer proficiency
Computer literacy in MS Word, Excel, and PowerPoint
·Communication - advanced
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
·Project management
Experience coordinating/executing moderately complex projects
·Time management
Comfortable working in a dynamic, fast-paced environment. Responsive to requests/input
Ability to develop/learn new skills
·Knowledge of field
Knowledge of hematology, oncology, and/or bone marrow transplant clinical settings
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 yearsof 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)

·Masters 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