Position Focus :
As part of a multi-disciplinary research team in Transplant, cardiac and vascular surgery and related research, the Research Associate will be responsible for her / his own portfolio of clinical research projects including, as applicable, study start-up, recruitment, enrollment, data collection and data entry, lab processing and specimen shipment, as well as regulatory submissions and reports, safety reporting and medical billing compliance, in collaboration with the Principal Investigator(s) and under the supervision of the Manager of Clinical Research.
Trials in the portfolio may be industry sponsored, NIH funded, and / or investigator initiated.
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
or the equivalent combination of education or experience.
Required Skill / Ability 1 :
Proven work experience in a research or clinical setting.
Required Skill / Ability 2 :
Ability to work in a complex research and clinical setting on multiple projects in different stages of development; Excellent attention to detail.
Ability to set priorities.
Required Skill / Ability 3 :
Proven strong interpersonal skills. Ability to communicate effectively and collaborate with all levels of clinical team members, patients, providers, and external funders.
Strong written and oral communication skills.
Required Skill / Ability 4 :
Flexibility and willingness to learn new skills / adapt to different settings (outpatient, inpatient, study specific requirements).
Required Skill / Ability 5 :
Proficiency with MS Office suite.
Preferred Education, Experience and Skills :
Knowledge of clinical research regulatory requirements, familiarity with electronic medical record system, database navigation.
Prior clinical trial experience.
Drug Screen
Health Screening
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.
Last updated : 2024-05-20
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