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 Skill/ability 1:  Ability to identify, assesses eligibility, and collect accurate medical and demographic history on research subjects for a variety of studies; and, ability to obtain and explain written consent for subject participation. Ability to review, code and contribute in the entering of all collected patient data to assure completeness and accuracy.

Required Skill/ability 2:  Ability to contribute to protocol development, submission and renewal by collections written materials and writing procedural documents. Ability to ensure ongoing compliance with institutional review board (IRB) policies by monitoring changes in IRB policies related to human specimens and informing the research team of such changes.

Required Skill/ability 3:  Ability to collaborate with multidisciplinary researchers to coordinate research programs that integrate new advances in clinical trials.

Required Skill/ability 4:  Working proficiency with MS Office Excel, Word, and Outlook. Ability to ensure regulatory compliance by maintaining clinical research records to meet the needs of various protocols.

Required Skill/ability 5:  Ability to interface with external agencies and provides appropriate information. Leads committees or task forces to address and resolve research protocol operational issues.

Preferred Education:  

Bachelors of Science Degree in a scientific area. Five years of related experience or an equivalent combination of education and experience.

regulatory experience such as experience with submission of Human Investigation Committee (HIC) or Institutional Review Board (IRB) documents.