Clinical Research Coordinator

The Department of Medicine and Division of Digestive Diseases is seeking a detailed and dynamic Clinical Research Coordinator. In this role, you will coordinate research studies, identify participants, and assist the Principal Investigator (PI) with patient eligibility. Responsibilities also include facilitating the informed consent process, educating participants about protocol requirements, and emphasizing the significance of protocol compliance. The role requires maintaining all necessary documentation in accordance with FDA regulations, Good Clinical Practice (GCP) guidelines, and the funding source. This includes managing patient registration, data, and treatment assignment. This role will involve quality control and assurance activities related to study workflows and documentation. In addition, the Clinical Research Coordinator is responsible for procuring and distributing study supplies, including coordinating specimen collection and shipping. Ensuring the safe and accurate completion of protocol-required procedures according to regulatory guidelines, FDA CFR, GCP, and institutional best practices is essential.

Hourly range: $33.63-$54.11

Required:

• 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.
• Strong organizational capabilities to organize multiple projects and competing deadlines for efficiency and cost-effectiveness.
• Analytical skills sufficient to work and solve address problems and identify solutions with reasoned judgment.
• Ability to adapt to changing job demands and priorities; work flexible hours to accommodate research deadlines.
• Ability to concentrate and focus in a work environment that contains distracting stimuli and competing deadlines.
• 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