Under the general direction of the UMCCTS Director and CTSA PI or designee, the Clinical Research Navigator will provide day-to-day support and guidance for clinical investigators and research staff on operational issues and study execution; support and inform initiatives related to electronic information resources such as the Clinical Trial Management System and Electronic Medical Records, inform and support the connection of study sponsors to potential Principal Investigators, serve as the liaison between UMass Chan Medical School and UMass Memorial Health, and the principal point of contact for UMass Chan in the NIH-NCATS CTSA clinical trials.

**This is a hybrid work model with the understanding that the Clinical Research Navigator will be available and onsite as required to support the department**

• Ensure Investigators and study teams are able to identify and connect with required resources within UMass Chan or UMMH to accomplish research goals
• Facilitate the connection to core services and develop and maintain standardized processes and guidance information on resource navigation necessary for implementation and performance of clinical research
• Develop resources for and assist in connection of industry initiated study opportunities to appropriate Principal Investigator and study teams
• Be the principal point of contact for the NIH-NCATS CTSA clinical trials, assisting investigators in the conduct of multi-site NIH sponsored clinical trials;
• Define key strategies for optimizing cross-system efficiencies and shared policy development priorities, including research billing compliance
• Collaborate with Director on assessment of existing Standard Operating Procedures and development of needed SOPs, including Good Clinical Practice;
• Serve as key resource and subject matter expert on the clinical trial management system and electronic medical records systems as related to research;
• Represent UMass Chan clinical research initiatives in cross-team and cross-institution working groups related to clinical research implementation in the UMMH environment and inform parties regarding standard research practices;
• Advise and consult with clinical investigators and clinical research staff on individual study projects, focusing on feasibility, initiation issues and best practices;
• Support education and awareness on clinical research billing requirements for appropriate research billing;
• Advise investigators on navigation of the Investigational New Drug/Investigational New Device application.
• Serve as a resource for OCR staff and study teams related to assessment of clinical costs in clinical research budgets;
• Perform other duties as required.

• Bachelor degree in a health-related field, or equivalent experience
• 5 years of clinical study coordination or study management experience (drugs, devices)
• Understanding of federal, state regulations and guidance related to clinical research;
• Understanding of Good Clinical Practice guidelines;
• Understanding of Clinical Research Billing requirements;
• Ability to work independently on multiple projects and prioritize confidential issues
• Superior communication, organizational and interpersonal skills, attention to detail and ability to facilitate cross-system decisions
• Ability to problem-solve and work under pressure in a deadline-driven environment
• Ability to travel to off-site locations

PREFERRED QUALIFICATIONS:

• RN or Master’s degree in health-related field
• Experience in an academic health center or hospital
• Understanding of the Investigational New Drug/Investigational New Device application process;
• Certification as research coordinator or in other research domain preferred (CCRA, CIP)