Research Associate 2 HSS

Location
Connecticut, United States
Posted
Wednesday, 21 October 2020
End of advertisement period
Monday, 21 December 2020
Ref
62859BR
Contract Type
Fixed Term
Hours
Full Time

Position Focus:

  • Develops procedures/manuals s for data collection, coding and collection of any bio-specimens based on the study protocols and in collaboration with the investigators.
  • Develops original HIC/IRB submissions.
  • Monitors and ensures adherence to all human subject research regulations of all investigators and good clinical practice guidelines, and prepares monitoring reports. Registers the study at clinicaltrials.gov and updates study progress.
  • Works with database specialist(s) (e.g., OnCore) for electronic implementation of case report forms, administrate database user access, and provides technical support to investigators.
  • Assists the investigators in assessing the feasibility of a project through analysis of staffing needs, resource requirements, financial costs, and current planned capacity of group.
  • Identifies vendors and negotiates contracts for research related services.
  • Serves as the primary contact among investigators, vendors, IRB and funding agencies.
  • Performs and presents descriptive data analysis.Assures data integrity and contributes to the study dissemination.
  • Registers the study at clinicaltrials.gov and updates study progress.
  • Assures data integrity and contributes to the study dissemination.

Essential Duties

  1. 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.
  2. Develops criteria for admission of study subjects based on goals and objectives of project.
  3. Determines potential sources of funding and prospective partnerships.
  4. 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.
  5. 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.
  6. Develops forms, questionnaires and the application of research techniques; writes procedures manuals for data collection and coding.
  7. 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.
  8. 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.
  9. Performs descriptive and multivariate statistical analyses of data, using computer software.
  10. Designs and implements quality control measures to ensure accurate collection and processing of data.
  11. 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:

Working knowledge of OnCore and Microsoft Office.

Required Skill/Ability 2:

Familiarity with FDA/NIH and ICH/GCP guidelines in order to ensure study compliance.

Required Skill/Ability 3:

Ability to train and supervise research staff.

Required Skill/Ability 4:

Ability to organize, prioritize and track multiple deliverables.

Required Skill/Ability 5:

Well-developed written and verbal communication skills.

Preferred Education, Experience and Skills:

Experience developing, implementing and modifying data entry systems.

Weekend Hours Required?

Occasional

Evening Hours Required?

Occasional

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.

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.

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: ocr.boston@ed.gov.

Note

Yale University is a tobacco-free campus

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