Research Assistant, Regulatory Affairs

Yale University - Yale, MI - Essential Duties 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. 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. Weekend Hours Required? Occasional Evening Hours Required? Occasional Duration Type Regular Work Week Standard (M-F equal number of hours per day) Drug Screen No Health Screening No Original Posting Date 02-Dec-2020 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 https://ift.tt/1mVwjc3 for additional information on the background check requirements and process. Searchable Job Family Research Res Support, Research/Support Total # of hours to be worked: 37.5 Position Focus: 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. 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. 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. Compensation Grade Labor Grade C Bargaining Unit L34 - Local 34 (Yale Union Group) Supervisory Organization Comprehensive Cancer Center - Clinical Trial Operations Time Type Full time 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 intermediate to advanced computer skills with Excel and Word. Required Skill/Ability 5: Proven ability to communicate effectively, both verbally and written. Note Yale University is a tobacco-free campus... - Permanent - Full-time

source http://jobviewtrack.com/en-in/job-1b4a417f48031a0246004f1111412f0103411d1a1a536b584e445e100e00537672060f140206114f061149324c4d5c445f176d3c420745021a020647245307011a074b45492f7f01081b4b15540c1a184e2616531d1b1d12445f3f7f48031a0246004f1111413c021645151a0a1b2b1a0e1a1950/32a1b8394bb228233847be23ef54d194.html?affid=f584d43114bf1954a48e3ec6be21b6ec