Non-Clinical - Administrative/Clinical Research Coordinator

We are seeking a dedicated and detail-oriented individual to contribute to the overall operational management of clinical research/trial/study activities from design, set up, conduct, through closeout. This role is crucial in ensuring the successful implementation of research activities for one or more studies. The candidate will be responsible for planning and organizing necessary tasks to ensure adherence to the study protocol and applicable regulations, including institutional policy and procedures, FDA Code of Federal Regulations (CFR), and ICH Good Clinical Practice (GCP).

The successful candidate will collaborate with the Principal Investigator (PI), ancillary departments, central research infrastructure teams, sponsors, institutions, and other entities as needed to support the administration of all aspects of studies, including compliant conduct, financial management, and adequate personnel support.

• Bachelor's Degree or 1-3 years of previous study coordination or clinical research coordination experience
• Working knowledge of FDA Code of Federal Regulations (CFR) and ICH Good Clinical Practice (GCP) for clinical research
• Strong verbal and written communication skills along with strong interpersonal skills to effectively establish rapport, and build collaborative relationships
• Strong organizational capabilities to manage multiple projects and competing deadlines for efficiency and cost-effectiveness
• Analytical skills sufficient to 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 respond to situations in an appropriate and professional manner
• 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 skills including word-processing, use of spreadsheets, email, and data entry. Ability to navigate numerous software programs and applications
• Ability to handle confidential material information with judgment and discretion
• Working knowledge of the clinical research regulatory framework and institutional requirements
• Mathematical skills sufficient to prepare clinical research budgets, with knowledge of clinical trials research budgeting processes
• Be available to work in more than one environment, travel to meetings, off-site visits, conferences, etc.