1. Works closely with investigators and other study team members including the project manager, for projects or programs of a small to medium size or sections of larger projects and programs to consult, conduct analysis, and identify trial objectives and requirements within specific parameters. 2. Interprets research business needs and translates them into application and operational requirements for a specific area(s) of research. Develops necessary tools and workshops to successfully elicit requirements. 3. Critically evaluates information gathered from multiple sources - research protocols, clinical trial agreements, financial budgets and fees associated with research - to reconcile conflicts, and decompose high-level information into data essentials. 4. Analyzes data with standard methods, interprets the results, and provides written summary and reporting of data analysis. Develops reporting modules, ad-hoc reports and related reporting tools. Conducts research, data analysis, modeling, projecting and scenario analyses, with the aid of planning technology and databases 5. Develops and maintain documentation and libraries on key processes. 6. Assesses risk and ensures compliance with research protocols/guidelines, university procedures, and third party regulations. 7. Determines training needs, designs, develops and conducts training sessions, meetings and conference calls with study teams and staff members. 8. Performs or assists with research compliance audits or self-assessments. 9. Communicates effectively the perspective of business opportunities, needs, and risks.
Required Skill/ability 5: Proven ability to effectively communicate with human subject volunteers while demonstrating adherence to the standard practices of consent, retention, and deployment of e-applications required for study participation.
Posting Position Title: Clinical Research Analyst 1
Required Skill/ability 3: Provide required recruitment and resource information for assigned projects, grant applications and/or industry feasibility and qualification requirements.
Work Week: Standard (M-F equal number of hours per day)
University Job Title: YCCI Clinical Research Project Coordinator 1
Required Skill/ability 1: Proven experience with EMR and/or CTMS clinical research management.
Required Skill/ability 4: Ability to independently manage a small to medium sized human subject project as well as contribute to overall clinical research recruitment across all disciplines.
Required Skill/ability 2: Ability to provides direction to investigators to strengthen their research and ensure regulatory, protocol, and research billing compliance.
Bachelor's degree in a related field and two years of related work experience in the same job family or an equivalent combination of experience and education. Must be knowledgeable in regional and federal regulations with the ability to perform independent decision-making on a daily basis; Epic, OnCOre, tele and video consenting.
Yale University is an American private Ivy League research university located in New Haven, Connecticut. Founded in 1701 in the Colony of Connecticut, the university is the third-oldest institution of higher education in the United States.