YCCI Clinical Research Coordinator

07-Feb-2024

YSM Cores – YCCI

86623BR

University Job Title

Coordinator 4, Research Support

Bargaining Unit

None – Not included in the union (Yale Union Group)

Compensation Grade

Administration & Operations

Compensation Grade Profile

Supervisor; Senior Associate (23)

Wage Ranges

Click here to see our Wage Ranges

Searchable Job Family

Research Res Support

Total # of hours to be worked:

37.5

Work Week

Standard (M-F equal number of hours per day)

Work Location

Medical School Campus

Worksite Address

2 Church Street South Doctor’s Building
New Haven, CT 06519

Position Focus:

Under the direction of the Associate Director and RN Manager, the Clinical Research Coordinator 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.

Essential Duties

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.

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.

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. Ability and skill for laboratory processing, phlebotomy and vital sign execution. EKG capabilities strongly preferred.

Preferred Licenses or Certifications:

Clinical Coordinator Certification (SoCRA or equivalent).

Weekend Hours Required?

Occasional

Evening Hours Required?

Occasional

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.

COVID-19 Vaccine Requirement

The University maintains policies pertaining to COVID-19. All faculty, staff, students, and trainees are required to comply with these policies, which may be found here:
https://covid19.yale.edu/health-guidelines

Posting Disclaimer

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.

EEO Statement:

University policy is committed to affirmative action under law in employment of women, minority group members, individuals with disabilities, and protected veterans. Additionally, in accordance with Yale’s Policy Against Discrimination and Harassment, 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