YCCI Clinical Research Coordinator

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

1. Compares protocols and sponsored projects to confirm consistency between funding proposals/awards and approved protocols.
2. Documents established congruency between funding proposals and approved protocols.
3. Facilitates and/or assists with resolution of any inconsistencies between funding proposals and approved protocols.
4. Serves as a liaison between the Grants and Contracts offices, investigators, and business managers to resolve congruency issues in a timely manner.
5. Attends meetings and presents issues when necessary that were identified during congruency review.
6. Serves as a resource and provides technical assistance to investigators and their staff.
7. Provides analytical and technical support related to establishing and recording protocol/grant congruency, as needed.
8. Monitors federal and state regulations for new guidance, updates, or policies. Maintains a high degree of knowledge on these requirements to determine actions and follow directives that may be required to ensure University compliance with congruency review and reporting requirements.
9. Develops, implements, and manages internal practices that ensure compliance with federal requirements.
10. May perform other duties as assigned.

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.