YCCI Clinical Research Coordinator

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Overview
Within the Yale Center for Clinical Investigation (YCCI), the Clinical Research Coordinator plays a pivotal role in ensuring the compliance and execution of research studies funded by various sources. This position involves managing the full spectrum of clinical research activities from study start-up, patient recruitment, data collection, and regulatory submissions to overseeing compliance with federal regulations and university policies. The Coordinator is responsible for coordinating research actions, engaging directly with study participants, and maintaining accurate documentation and data management. This role also involves liaising with sponsors, regulatory bodies, and various stakeholders to facilitate smooth progression and adherence to study protocols. The Coordinator may work on multiple clinical research projects across different medical fields, requiring flexibility, meticulous attention to detail, and the ability to manage multiple priorities effectively. Maintaining the highest standard of regulatory compliance is essential.

Required Skills and Abilities
1. Proven ability to manage clinical research projects, adhering to established protocols and regulatory requirements.
2. Strong communication skills, both verbal and written, with the capacity to interact effectively with all levels of clinical teams, patients, and regulatory authorities.
3. Exceptional organizational and time management skills, with the ability to handle multiple projects and deadlines simultaneously.
4. Proficiency in using electronic data capture systems, such as EPIC, for clinical trial management.
5. Demonstrated ability in obtaining informed consent and handling research subject interactions and documentation.

Preferred Education and Experience
1. Bachelor's degree in health or research-related discipline and three years of related work experience in clinical research coordination.
2. Certified Clinical Research Professional (CCRP) or equivalent certification.
3. Experience with FDA/regulatory submissions and compliance, specifically within clinical trials.
4. Advanced skills in data management and analysis, including the use of tools like REDCap, Excel, and OnCore.
5. Familiarity with multi-specialty research, with hands-on experience in patient recruitment and study management.

Principal Responsibilities

Required Education and Experience

Bachelor’s degree in a relevant academic/scientific field and a minimum of 3 years of related research support experience; or the equivalent combination of education or experience.

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Background Check Requirements

All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.

Health Requirements

This role is a healthcare worker position. Healthcare workers (HCW) are defined as university employees working a healthcare setting who have the potential for direct or indirect exposure to patients, human research subjects or infectious materials including body substance, contaminated medical supplies, devices and equipment, surfaces, or air.  HCW have specific health requirements that must be met prior to starting work, including MMR vaccine or immunity, varicella (chickenpox) vaccine or immunity, TB screening, COVID vaccine according to University policy, hepatitis B vaccine or immunity, and annual flu vaccination.

Posting Disclaimer

Salary offers are determined by a candidate’s qualifications, experience, skills, and education in relation to the position requirements, along with the role’s grade profile and current internal and external market conditions.

The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the position. Employees will be assigned specific job-related duties through  their hiring department.

The University is committed to basing judgments concerning the admission, education, and employment of individuals upon their qualifications and abilities and seeks to attract to its faculty, staff, and student body qualified persons from a broad range of backgrounds and perspectives. In accordance with this policy and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual’s sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.

Inquiries concerning Yale's Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA).

Note

Yale University is a tobacco-free campus.