Clinical Research Assistant
This position is primarily located in Guilford, Connecticut, with coverage sometimes requested for other locations. There will also be occasional meetings which one must attend in New Haven, Connecticut.
Yale Cancer Center is Connecticut's only cancer center designated as a Comprehensive Cancer Center by the National Cancer Institute (NCI) and one of only 47 in the nation. Yale Cancer Center delivers the highest quality patient-centered care, achieves breakthrough discoveries, and trains the future leaders in cancer science and medicine. There are over 190 clinical trials providing the most advanced cancer therapies at Smilow Cancer Hospital and in the 11 Care Centers, and trials are available within 20+ disease units. Yale has been at the forefront of understanding the fundamental mechanisms of cancer biology and in developing effective therapies for the treatment of cancer, and harnesses the resources of the Yale School of Medicine and Smilow Cancer Hospital at Yale-New Haven to advance cancer research, prevention, and patient care, as well as community outreach and education.
The Clinical Research Assistant (CRA) will provide Yale Cancer Center/Clinical Trials Office with direct clinical and data management support related to the conduct of clinical trials and the, collection and reporting of study-related clinical data for clinical studies within the assigned Disease team or area. Through the use of independent judgment and high level decision- making, extract, record, and disseminate treatment-related information for regular reporting and monitoring by the research team and study sponsors.
- Researches and collects data through site or home visit intakes; library research; structured interviews; or through other means for research projects.
- Interprets, synthesizes, and analyzes data using scientific or statistical techniques. Modifies and plans research experiments, procedures, tests, or survey instruments. Assists in research design.
- Writes and edits material for publication and presentation. Reports on status of research activities. Oversees and instructs research and support staff on technical procedures, equipment operation, and laboratory maintenance.
- Schedules and coordinates research activities. Identifies and recruits study participants. Orders and maintains inventory of supplies.
- May assist in preparing financial information and monitoring budgets.
- Performs additional functions incidental to research activities.
Required Education and Experience
Two years of related work experience in the same job family and a Bachelor's degree in a related field; or an equivalent combination of experience and education.
Required Skill/Ability 1:
Advanced computer proficiency with Excel, Word and proven ability with electronic medical databases.
Required Skill/Ability 2:
Ability to coordinate study participant care from the recruitment phase through off treatment and follow up phase. This coordination may require the scheduling and verification of appointments.
Required Skill/Ability 3:
Ability to abstract, create, and maintain a study participant’s research record ensuring all required data is collected, source verified, and entered into sponsor databases.
Required Skill/Ability 4:
Impeccable interpersonal skills and the ability to work as a team as well as independently while self- motivating. Professional appearance and manner as well as an excellent attendance record. Ability to travel to New Haven, CT for meetings. Ability to provide coverage outside of Guilford, CT by request.
Required Skill/Ability 5:
Proven ability to multi-task, maintain confidentiality and manage a broad variety of duties and shifting priorities in a changing environment and to be organized and meticulous with details.
Preferred Education, Experience and Skills:
Experience coordinating, planning or working in a high volume multi-task setting. Experience working with study sponsor personnel. Knowledge of Oracle software, Medidata Rave, EPIC and ONCORE. Knowledge of federal regulations for HIPAA and IRB. Experience working in a Clinical Trials setting preferred. Oncology experience preferred. Completion of Good Clinical Practice training.
Preferred Licenses or Certifications:
Certification as a Clinical Research Associate or Clinical Research Professional (ACRP or SOCRA) preferred.
Weekend Hours Required?
Evening Hours Required?
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.