Description The Clinical Research Coordinator supports the operational management of clinical research activities throughout the study lifecycle, including design, start-up, conduct, and closeout. This role is responsible for implementing and managing research activities for one or more studies, prioritizing tasks to meet required deadlines. The Coordinator plans and organizes study activities to ensure compliance with study protocols and applicable regulations, including institutional policies, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP).
The role involves close collaboration with the Principal Investigator, ancillary departments, central research teams, sponsors, and external institutions to support compliant study conduct, financial management, and adequate staffing. Hourly salary range: $38.19 - $61.45 Qualifications Required: Bachelor's degree in related area and/or equivalent combination of education and experience. Minimally 2+ years of previous study coordination or clinical research coordination experience Interpersonal skills to effectively communicate information in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators and administration and to work as a member of a team.
Ability to effectively communicate to and interact with patients in a compassionate and kind manner. Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations. Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions.
Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment. Organization skills to create and maintain administrative and regulatory files effectively as well as independently balance the various tasks to ensure deadlines are met. Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately.
A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently Working knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws. Knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc.
Strong verbal and written communication skills to effectively establish rapport, building collaborative relationships, and communicate complex concepts and ideas in an easy-to-understand manner. Ability to adapt to changing job demands and priorities, remain flexible including working flexible hours to accommodate research deadlines. High degree of concentration and focus in a work environment that contains distracting stimuli, competing deadlines, and work delegated by more than one individual Availability to work in more than one environment, travelling to various clinic sites, meetings, conferences, etc.