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YCCI Clinical Research Coordinator
3 months ago
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 pertains 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 the Yale team and potential study sponsor.
Essential Duties
1. Evaluates and assesses subject’s suitability for inclusion in studies; develops and modifies procedures according to study findings; recommends changes to the study protocol to coincide with study goals and objectives. 2. Develops and implements procedures and data quality assurance standards for safety monitoring components of studies. 3. Contributes to designing activities, policies and procedures to improve day to day efficiency of the recruitment and assessment components of the study and to ensure that staff members perform activities within established research protocol. 4. Arranges patient enrollment, determines patient eligibility and obtains informed consent. 5. Develops study subject referral sources; designs and develops outreach programs. 6. Collaborates with multidisciplinary researchers to coordinate research programs that integrate new advances in clinical trials. 7. Delegates tasks and supervises the activities of other licensed and unlicensed care providers. 8. May perform other duties as assigned.
Required Education and Experience
Bachelor’s of Science Degree in Nursing and four years of related experience or an equivalent combination of education and experience.
Required Skill/Ability 1:
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 must indicate 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.
Required Licenses or Certifications
Licensure as Registered Nurse in the State of Connecticut or Connecticut license eligible.
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. 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:
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.
