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Position Focus:
The Research Associate II will function in a multidisciplinary team environment, coordinating the design, implementation and evaluation of public health outcomes research projects conducted by investigators in the department of General Internal Medicine and at the Center for Outcomes Research and Evaluation (CORE).

Under the direction of the Principal Investigator and Senior Project Manager, the ideal candidate will participate in all aspects of project coordination, implementation, and reporting of results related to a variety of regulatory science and data sharing research projects, including the Yale-Mayo Center of Excellence in Regulatory Science and Innovation (CERSI) and the Collaboration for Research Integrity and Transparency (CRIT). General responsibilities of the Research Associate II will be to coordinate and lead regular meetings that include agenda preparation and meeting minute documentation, manage internal and external communications, timelines, and research activities for research projects, such as to develop study procedures and protocols, prepare written and oral reports and presentations, and data interpretation and summarization. Specific projects are likely to include research to better understand the adoption / de-adoption of medical products, postmarket surveillance of these products, electronic health record testing of common data models for surveillance, and integration of this information into patient-centered care, as well as the public health implications of medical product regulation, clinical research integrity, and data transparency. The Research Associate II will communicate information and data in written and verbal form to colleagues, sponsors, senior management, government officials and the public, including the development of public materials and reports for various constituencies. The individual will work with a number of multidisciplinary research teams and ensure project goals and deliverables are met with high customer satisfaction.

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
Masters Degree in a related discipline and two years of experience or an equivalent combination of education and experience.

Required Skill/Ability 1:
Well-developed project coordination skills as demonstrated by prior job-related research experience.

Required Skill/Ability 2:
Demonstrated excellent organizational ability, attention to detail, efficiency, and critical thinking, as well as strong communication skills that include the ability to communicate effectively and diplomatically in written and verbal forms with internal and external contacts, faculty, leadership, and staff.

Required Skill/Ability 3:
Ability to produce high quality work with minimal supervision and be receptive to feedback and direction in a fast-paced team environment. Possess thorough knowledge of research methodologies and protocols.

Required Skill/Ability 4:
Proficient in Microsoft WORD, EXCEL, POWERPOINT, and OUTLOOK.