Research Assistant, Regulatory Affairs
Yale Cancer Center is Connecticut's only cancer center designated as a Comprehensive Cancer Center by the National Cancer Institute (NCI). 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 300 clinical trials providing the most advanced cancer therapies at Smilow Cancer Hospital and in the 15 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.
Reporting to the Regulatory Manager, the Research Assistant 1 provides regulatory affairs support with administrative maintenance and follow-up for the Yale Cancer Center (YCC) Clinical Trials Office (CTO). Responsibilities include, but are not limited to, creation and maintenance of regulatory files and documentation involving study regulatory requirements, maintenance of external adverse event reports (safety reports), scanning and uploading regulatory documents as well as processing minor amendments.
- Researches and collects data through site or home visit intakes; library research; structured interviews; or through other means for designated research assignments.
- Records and compiles information related to research data. Codes data accordingly to research specifications. Uses a computer terminal to input and retrieve data and to generate reports.
- Processes and summarizes data using scientific or statistical techniques. Assists in data interpretation and analyses. Reports on status of research activities.
- Recruits study participants and ensures that subject recruitment and follow-up are completed per protocol procedures.
- Orders and maintains inventory of supplies. May assist in designing, developing, and modifying research experiments, procedures, or survey instruments. May assist research and support staff.
- Performs additional functions incidental to research activities.
Required Education and Experience
Six years of related work experience, four of them in the same job family at the next lower level, and high school level education; or four years of related work experience and an Associate's degree; or little or no work experience and a Bachelor's degree in a related field; or an equivalent combination of experience and education.
Required Skill/Ability 1:
Ability to work in a clinical or research environment. Working knowledge of medical terminology.
Required Skill/Ability 2:
Proven ability to multi-task, maintain confidentiality and remain focused in a fast-paced environment. Proven ability to be meticulous with details.
Required Skill/Ability 3:
Demonstrated impeccable interpersonal skills and the ability to work as part of a team and independently. Demonstrated professional appearance and manner as well as an excellent attendance record.
Required Skill/Ability 4:
Demonstrated advanced computer skills with Excel and Word.
Required Skill/Ability 5:
Proven ability to communicate effectively, both verbally and written.
Preferred Education, Experience and Skills:
Oncology terminology a plus. Prior experience with research-related regulatory documentation. Fundamental knowledge of Food and Drug Administration (FDA) regulations and International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines governing the protection of human research subjects.
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.
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