Clinical Research Analyst
University Job Title: Clinical Research Analyst
Bargaining Unit: None - Not included in the union (Yale Union Group)
Time Type: Full time
Duration Type: Regular
Compensation Grade: Administration & Operations
Compensation Grade Profile: Supervisor; Senior Associate (21)
Work Location: Medical School Campus
Worksite Address: 15 York Street New Haven, CT 06510
Work Week: Standard (M-F equal number of hours per day)
Searchable Job Family: Research Res Support
Total # of hours to be worked: 37.5
The primary responsibility of the research coordinator is to manage all aspects of conducting clinical trials/ research studies. The research coordinator is required to have knowledge of protocol requirements and good clinical practices as set forth by federal regulations. As the primary resource for the protocols, the research coordinator will act as liaison between the investigators, primary care providers, the institutional review board (IRB) and the sponsor. Along with the investigator, the research coordinator will screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. In addition, the coordinator is responsible for all data and source documentation, adverse experience reporting and maintenance of complete regulatory files.
1. Works closely with investigators and other study team members including the project manager, for projects or programs of a small size or sections of medium projects and programs to consult, conduct analysis, and identify trial objectives and requirements within specific parameters.2. Interprets research business needs and translates them into application and operational requirements for a specific area(s) of research. Develops necessary tools and workshops to successfully elicit requirements.3. Critically evaluates information gathered from multiple sources – research protocols, clinical trial agreements, financial budgets and fees associated with research - to reconcile conflicts, and decompose high-level information into data essentials.4. Analyzes data with standard methods, interprets the results, and provides written summary and reporting of data analysis. Develops reporting modules, ad-hoc reports and related reporting tools. Conducts research, data analysis, modeling, projecting and scenario analyses, with the aid of planning technology and databases5. Develops and maintain documentation and libraries on key processes.6. Assesses risk and ensures compliance with research protocols/guidelines, university procedures, and third party regulations. 7. Determines training needs, designs, develops and conducts training sessions, meetings and conference calls with study teams and staff members.8. Performs or assists with research compliance audits or self-assessments.9. Communicates effectively the perspective of business opportunities, needs, and risks.
Required Education and Experience
Bachelor’s degree in a related field and one year of related work experience in the same job family or an equivalent combination of experience and education. Must be knowledgeable in regional and federal regulations with the ability to perform independent decision-making on a daily basis.
Required Skill/Ability 1:
Working knowledge in preparing IRB submissions, protocol revisions and renewals as needed, and maintaining copies of all IRB communications.
Required Skill/Ability 2:
Demonstrated ability to create and follow research project-related supporting documents.
Required Skill/Ability 3:
Proven ability to schedule and 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.
Required Skill/Ability 4:
Excellent time management and organizational skills. Strong interpersonal skills with the proven ability to communicate effectively.
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.