Job Abstract

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: $32.65-$52.53 Hourly

• Bachelors Degree or 1-3 years of previous study coordination or clinical research coordination experience
• Strong verbal and written communication skills along with strong interpersonal skills to effectively establish rapport, and build collaborate relationships.
• Analytical skills sufficient to work and solve address problems and identify solutions with reasoned judgment.
• Ability to be flexible in handling work delegated by more than one individual.
• Typing and computer skill/ability including word-processing, use of spreadsheets, email, data entry. Ability to navigate numerous software programs and applications.
• Ability to handle confidential material information with judgement and discretion.
• Working knowledge of the clinical research regulatory framework and institutional requirements.
• Mathematical skills Sufficient to prepare clinical research budgets, knowledge of math ability and knowledge of clinical trials research budgeting process to assist with the preparation of clinical trial budgets.
• Working knowledge of FDA Code of Federal Regulations (CFR) and ICH Good Clinical Practice (GC) for clinical research.
• Ability to work at more than one site, travel to participating clinics and attend off-site staff meetings, conferences and investigators meetings.