Under the general supervision of Yale Cardiovascular Research Group Director, Director of Operations and within the framework of the Phase I-IV clinical trials, the Research Associate 2, HSS will be responsible for the quality assurance for clinical trials and the core laboratories. Management of quality assurance for core laboratories, with autonomy, productivity and quality.
- Carries out research within the scope of the established study protocol. Adheres to all human subjects regulations as defined by Yale University and the federal government that pertain to research studies.
- Develops criteria for admission of study subjects based on goals and objectives of project.
- Determines potential sources of funding and prospective partnerships.
- Evaluates feasibility of accepting potential projects through analysis of staffing needs, resource requirements, financial costs, and current planned capacity of group. Negotiates contracts and/or changes with funder.
- Develops original HIC/IRB submissions. Based on knowledge of science and research goals, collaborates with PIs on major revisions and contributes to scientific protocols. Plans and implements changes.
- Develops forms, questionnaires and the application of research techniques; writes procedures manuals for data collection and coding.
- Responsible for the documentation and transmission of study data. Ensures that report forms are accurately documented and completed in a timely manner at each site location.
- Works independently to develop manage and organize multi site studies. Serves as primary coordinator between University, non-Yale collaborators, pharmaceutical companies, HIC, IRB and funding sources.
- Performs descriptive and multivariate statistical analyses of data, using computer software.
- Designs and implements quality control measures to ensure accurate collection and processing of data.
- Contributes in-depth, original thought and relevance to written reports and to the writing of abstracts and manuscripts.
Required Education and Experience
Master’s Degree in a related discipline and two years of experience or an equivalent combination of education and experience.
Required Skill/Ability 1:
Excellent interpersonal skills including the ability to communicate with trial sponsors, clinical sites and other trial management teams.
Required Skill/Ability 2:
Strong focus on flexibility, ability to multitask, attention to detail, excellent organizational skills, good follow-up and judgement. Ability to prioritize.
Required Skill/Ability 3:
Ability to verbally communicate effectively with staff, physicians, nurses, managers, trial sponsors and colleagues.
Preferred Education, Experience and Skills:
Detailed knowledge of ISO 9001 Certification is preferred. Registered Nurse or MD training preferred. Knowledge of medical terminology and morphology of the heart preferred. Pathophysiology of Cardiovascular disease preferred. Excellent writing skills a plus.
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: firstname.lastname@example.org.
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