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Description

The mission of the Coordination Services and Education (CSE) unit in the CTSI's Office of Clinical Research (OCR) is to provide a sales and service solution to investigators and study teams seeking assistance with clinical research study start up, on-study coordinator study and patient management, regulatory maintenance, data entry services and clinical research training and education through three dedicated teams: Study Activation Team, Clinical Research Coordinator Team and the Education and Training Team. Each Clinical Research Coordinator (CRC) supports multiple clinical research studies ensuring adherence to federal/local/institutional regulatory requirements, good clinical practice, data quality, protocol compliance, protection of human subjects, and overall quality assurance and quality management.

In this role, you will contribute to the overall operational management of clinical research/trial/study activities from design, set up, conduct, through closeout. You will be responsible for the implementation of research activities for one or more studies. As our Research Coordinator, you will recognize and perform necessary tasks to manage projects and prioritize work to meet necessary deadlines. You will be responsible for planning and organizing necessary tasks to ensure adherence to the study protocol and applicable regulations, such as institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP).

Salary Range: $33.63 - $54.11/Hourly

Qualifications

All Required:

+ Bachelors Degree or 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.

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