Clinical Research Coordinator
Under the direction of the Associate Director and RN Manager, the Coordinator 4 leads the research team in the execution of trials within the scope of the established study protocol. Adheres to all human subject’s regulations as defined by Yale University and the federal government that pertain to research studies. 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.
- 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.
Required Skill/Ability 1:
Proven ability to lead a research team in the execution of trials within scope of the established study protocol.
Required Skill/Ability 2:
Demonstrated skill in meticulous attention to study requirements, regulatory constraints, and accurate follow through. Ability to prepare and submit regulatory documents and maintenance requirements for the life of the trial(s).
Required Skill/Ability 3:
Thoroughly skilled in obtaining informed consent and related research subject interactions and requirements. Proven ability to track multiple occurrences and outcomes and document same in a timely manner. Exceptional organizational skills.
Required Skill/Ability 4:
Demonstrated independence and management skills among multiple study sites. Demonstrated ownership of communication requirements necessary for effective oversight and conduct of human clinical research utilizing multiple electronic data capture systems.
Required Skill/Ability 5:
Demonstrated ability and skill for laboratory processing and vital sign execution.
Preferred Education, Experience and Skills:
Bachelor’s degree in health or research related discipline and three years of related work experience in a similar job family. Experience indicating ability to work with minimal supervision in a team atmosphere and receptiveness to direction regardless of disease area. EKG capabilities and phlebotomy skills strongly preferred.
Preferred Licenses or Certifications:
Clinical Coordinator Certification (SoCRA or equivalent)
Weekend Hours Required? Occasional
Evening Hours Required? Occasional
Drug Screen No
Health Screening No
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. Please visit www.yale.edu/hronline/careers/screening/faqs.html for additional information on the background check requirements and process.
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 particular position. Employees will be assigned specific job-related duties through their hiring departments.
Affirmative Action Statement:
Yale University considers applicants for employment without regard to, and does not discriminate on the basis of, an individual’s sex, race, color, religion, age, disability, status as a veteran, or national or ethnic origin; nor does Yale discriminate on the basis of sexual orientation or gender identity or expression. Title IX of the Education Amendments of 1972 protects people from sex discrimination in educational programs and activities at institutions that receive federal financial assistance. Questions regarding Title IX may be referred to the University’s Title IX Coordinator, at TitleIX@yale.edu, or to the U.S. Department of Education, Office for Civil Rights, 8th Floor, Five Post Office Square, Boston MA 02109-3921. Telephone: 617.289.0111, Fax: 617.289.0150, TDD: 800.877.8339, or Email: email@example.com.
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