Yale University
Yale Clinical Research Coordinator
Working at Yale means contributing to a better tomorrow. Whether you are a current resident of our New Haven-based community-eligible for opportunities through the New Haven Hiring Initiative or a newcomer, interested in exploring all that Yale has to offer, your talents and contributions are welcome. Discover your opportunities at Yale! Salary Range $65,000.00 - $101,000.00 Under the direction of the Associate Director and RN Manager, the Clinical Research Coordinator leads the Yale Center for Clinical Investigation (YCCI) research team in the execution of clinical trials within the scope of the established study protocol. Adheres to all human subjects regulations as defined by Yale University and the federal government that pertain to research studies. Successful candidates will have the proven ability to coordinate research activities as well as work with a team to develop action items and other means to keep projects moving along according to timeline, with demonstrated ability to report on the status of project deliverables and draft and submit project updates to Yale team and potential study sponsor. The Clinical Research Coordinator will work across multiple locations within the Yale School of Medicine and nearby Yale West Campus. Required Skills and Abilities
Proven ability to manage clinical research projects, adhering to established protocols and regulatory requirements. Strong communication skills, both verbal and written, with the capacity to interact effectively with all levels of clinical teams, patients, and regulatory authorities. Exceptional organizational and time management skills, with the ability to handle multiple projects and deadlines simultaneously. Proficiency in using electronic data capture systems, such as EPIC, for clinical trial management. Demonstrated ability in obtaining informed consent and handling research subject interactions and documentation. Preferred Skills and Abilities
Bachelor's degree in health or research-related discipline and three years of related work experience in clinical research coordination. Certified Clinical Research Professional (CCRP) or equivalent certification. Experience with FDA/regulatory submissions and compliance, specifically within clinical trials. Advanced skills in data management and analysis, including the use of tools like REDCap, Excel, and OnCore. Familiarity with neurological or multi-specialty research, with hands-on experience in patient recruitment and study management. Fluency in Spanish preferred. Principal Responsibilities
Compares protocols and sponsored projects to confirm consistency between funding proposals/awards and approved protocols. Documents established congruency between funding proposals and approved protocols. Facilitates and/or assists with resolution of any inconsistencies between funding proposals and approved protocols. Serves as a liaison between the Grants and Contracts offices, investigators, and business managers to resolve congruency issues in a timely manner. Attends meetings and presents issues when necessary that were identified during congruency review. Serves as a resource and provides technical assistance to investigators and their staff. Provides analytical and technical support related to establishing and recording protocol/grant congruency, as needed. 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. Develops, implements, and manages internal practices that ensure compliance with federal requirements. 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. 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. Certain positions have associated health requirements based on specific job responsibilities. These may include vaccinations, tests, or examinations, as required by law, regulation, or university policy. 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. Yale University is a tobacco-free campus.
Working at Yale means contributing to a better tomorrow. Whether you are a current resident of our New Haven-based community-eligible for opportunities through the New Haven Hiring Initiative or a newcomer, interested in exploring all that Yale has to offer, your talents and contributions are welcome. Discover your opportunities at Yale! Salary Range $65,000.00 - $101,000.00 Under the direction of the Associate Director and RN Manager, the Clinical Research Coordinator leads the Yale Center for Clinical Investigation (YCCI) research team in the execution of clinical trials within the scope of the established study protocol. Adheres to all human subjects regulations as defined by Yale University and the federal government that pertain to research studies. Successful candidates will have the proven ability to coordinate research activities as well as work with a team to develop action items and other means to keep projects moving along according to timeline, with demonstrated ability to report on the status of project deliverables and draft and submit project updates to Yale team and potential study sponsor. The Clinical Research Coordinator will work across multiple locations within the Yale School of Medicine and nearby Yale West Campus. Required Skills and Abilities
Proven ability to manage clinical research projects, adhering to established protocols and regulatory requirements. Strong communication skills, both verbal and written, with the capacity to interact effectively with all levels of clinical teams, patients, and regulatory authorities. Exceptional organizational and time management skills, with the ability to handle multiple projects and deadlines simultaneously. Proficiency in using electronic data capture systems, such as EPIC, for clinical trial management. Demonstrated ability in obtaining informed consent and handling research subject interactions and documentation. Preferred Skills and Abilities
Bachelor's degree in health or research-related discipline and three years of related work experience in clinical research coordination. Certified Clinical Research Professional (CCRP) or equivalent certification. Experience with FDA/regulatory submissions and compliance, specifically within clinical trials. Advanced skills in data management and analysis, including the use of tools like REDCap, Excel, and OnCore. Familiarity with neurological or multi-specialty research, with hands-on experience in patient recruitment and study management. Fluency in Spanish preferred. Principal Responsibilities
Compares protocols and sponsored projects to confirm consistency between funding proposals/awards and approved protocols. Documents established congruency between funding proposals and approved protocols. Facilitates and/or assists with resolution of any inconsistencies between funding proposals and approved protocols. Serves as a liaison between the Grants and Contracts offices, investigators, and business managers to resolve congruency issues in a timely manner. Attends meetings and presents issues when necessary that were identified during congruency review. Serves as a resource and provides technical assistance to investigators and their staff. Provides analytical and technical support related to establishing and recording protocol/grant congruency, as needed. 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. Develops, implements, and manages internal practices that ensure compliance with federal requirements. 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. 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. Certain positions have associated health requirements based on specific job responsibilities. These may include vaccinations, tests, or examinations, as required by law, regulation, or university policy. 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. Yale University is a tobacco-free campus.