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Research Assistant, Regulatory Affairs
Yale University
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Research Assistant, Regulatory Affairs
Yale University
Details
Salary:
Open
Type:
Full-time
| 1. Researches and collects data through site or home visit intakes; library research; structured interviews; or through other means for designated research assignments. 2. 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. 3. Processes and summarizes data using scientific or statistical techniques. Assists in data interpretation and analyses. Reports on status of research activities. 4. Recruits study participants and ensures that subject recruitment and follow-up are completed per protocol procedures. 5. 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. 6. Performs additional functions incidental to research activities. Preferred Education: 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. 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. Required Skill/ability 5: Proven ability to communicate effectively, both verbally and written. Posting Position Title: Research Assistant 1 HSS 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. Work Week: Standard (M-F equal number of hours per day) University Job Title: Research Assistant, Regulatory Affairs Required Skill/ability 1: Ability to work in a clinical or research environment. Working knowledge of medical terminology. Required Skill/ability 4: Demonstrated intermediate to advanced computer skills with Excel and Word. 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.
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| 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. |
Internal Number: 63362BR
About Yale University
Yale University is an American private Ivy League research university located in New Haven, Connecticut. Founded in 1701 in the Colony of Connecticut, the university is the third-oldest institution of higher education in the United States.
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