Senior Clinical Research Workforce Program Coordinator
With minimal direction and considerable use of independent judgment, the Senior Clinical Research Workforce Program Coordinator will utilize clinical research expertise, communication skills, and experience/knowledge of process development to provide project leadership to the Clinical and Translational Science Institute. This position will focus on the development and operationalization of a new Clinical Research Coordinator (CRC) service that provide support to various short- and long-term research programs. These activities will support workforce development and institutional strategic initiatives that increase clinical research opportunities and new investigators.
Supervision and Direction:
Reports to and is given direction by the CTSI Director of Research Services and is accountable to senior team leaders according to specific service line activities.
Under general direction from the CTSI Director of Research Services and in close collaboration with senior team leaders and with considerable latitude for the exercise of independent judgement and initiative:
20% Trains and develops Human Subject Research Coordinator Trainees: Develops, delivers and monitors efficacy of training on the conducting of human subject research in accordance with approved protocols and in compliance with the Good Clinical Practices (GCPs), including training on policies and practices used by sponsors for the purpose of meeting regulatory requirements.
20% Directs the planning, implementation, coordination, operation and evaluation of trainee program. Manages and mentors research coordinators in the service line who have completed training. Provides professional direction within the trainee program.
15% Interacts with research enterprise stakeholders across the institution to evaluate needs, identify specific issues, and develops processes that will allow for training of new CRCs and deployment of CRCs from the service line to various UR research projects. Provides budget information and prepares financial reports based on the cost factors of the trainee program.
10% Prepares, analyzes, and monitors service line operating and financial reports and documents for review. Prepares analytical reports and recommendations for publication or grant requests and the like.
10% Prepares and makes presentations; collaborates with department and institutional colleagues to market the service line and respond to help desk queries related to the services. Develops functional and collaborative relationships with department leaders that assist in the development of the service line.
10% Develops training materials in collaboration with other groups and departments (e.g. .Office of Human Subject Protection, Learning and Development) for trainees to fulfill required competencies in study coordination.
5% Develops, documents and implements Standard Operating Procedures (SOPs) for managing and operating the coordinator pool. Apply metrics and quality improvement systems to monitor and improve the service line.
5% Keeps current with all federal, state, sponsor and institutional policies and laws, SOPs and guidelines. Manages and evaluates resulting study changes. Demonstrates accountability for continuous learning in accordance with GCPs. Keeps current with industry standards, best practices and trends in therapeutic areas relevant to research studies.
5% Other duties as assigned
• Excellent interpersonal, presentation, and communication skills, including written communication.
• Demonstrated experience planning and overseeing projects.
• Ability to function both independently and within a team.
• A process-driven thinker with an entrepreneurial and collaborative spirit.
• Excellent organizational skills and solid foundational and operational knowledge of clinical research.
• Bachelor’s Degree/Master’s degree strongly preferred. At least 5 years of documented experience as a CRC; ACRP or SOCRA certification strongly preferred; or an equivalent combination of education and experience.
• Experience managing and training CRCs and previous research coordinator experience.
• In depth understanding of workforce needs of clinical research including the ability to analyze a protocol and recommend research staffing based on communication with the Principal Investigator and/or department representatives.