Clinical Trials Coordinator - Urology

Under the direct supervision of the Clinical Trials Administrator, the Clinical Research Coordinator contributes to the overall operational management of clinical research / trial / study activities from design, set up, conduct, through closeout. The ideal candidate is an experienced professional who has direct responsibility for the implementation of research activities for one or more studies which may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities.

Duties of the role include:

• Recognizing and performing necessary tasks to manage projects and prioritizes work to meet necessary deadlines.
• Responsibility 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).
• Collaborating 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, but not limited to, compliant conduct, financial management, and adequate personnel support.

• 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 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 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.
• Be available to work in more than one environment, travel to meetings, off-site visits, conferences, etc.
• Collaborate with Principal Investigator (PI), ancillary departments, sponsors and other entities as needed to support the administration of all aspects of studies, including, but not limited to, compliant conduct, financial management, and adequate personnel support.
• Aid in the development and implementation of databases, applications, protocols, and proposals as required to support research.
• Supports the team in the development and production of all program/project deliverables including reports, presentations, website, social media content, communication, and other materials.
• Collaborates in works toward the completion of all program/project activities, research, outreach, and recruitment.
• Work with research participants on consent and surveys/interviews.
• Assists with producing weekly status reports, schedules, and drafts documents, data collection/data clean up, and analysis. Creates materials, develops and maintains databases.
• Working knowledge of FDA Code of Federal Regulations (CFR) and ICH Good Clinical Practice (GC) for clinical research