The Research Associate will be responsible for all enrollment and assessment activities at Yale New Haven Hospital and the Hospital of St. Raphael for a randomized clinical interventional study investigating the efficacy of a mobile-health (mHealth)-delivered cardiac rehabilitation program on clinical and functional outcomes among older adults with cardiac disease, as compared with usual care.
The individual hired will prepare and maintain all necessary documentation for the Yale IRB. They will screen potential subjects for eligibility through medical record review in EPIC, approach eligible subjects and administer informed consent, perform study assessments and chart abstraction, and enter data into a secure Research Electronic Data Capture (REDCap) database. The individual will also serve as the first point-of-contact for technical issues that may arise with beginning and maintaining the mHealth study intervention (e.g., enrolling participants in apps, troubleshooting technical issues with intervention tablets), and will also conduct the 3-month follow-up visit with study participants.
Human Subjects' Research - If applicable, updates and submits necessary documents required by the Yale Human Investigation Committee and any other appropriate parties in order to obtain approval to conduct human subjects research. Secures accurate signatures and forwards documents and/or forms to appropriate destination. Prepare and submit monthly enrollment statistics to the parent site’s research coordinator, and provide other information in timely manner, as necessary.
Study Regulations - Aware of study regulatory status and keeps an up to date copy of regulatory documents. Assists with the informed consent process and ensure that the patient/subject fully understands what is required of them throughout the study. Follows through regularly with the patient/subjects and reminds them of visits and compliance.
Research Activities - Collects patient information for the research project. This includes abstraction of data from the patient chart (e.g., laboratory or diagnostic test results, treatments delivered, adverse drug reactions, etc); abstraction of data for publications, or data collection from outside physicians’ offices. Uses tools to facilitate data collection (e.g. calendars, schedules, tracking logs, etc). Audits and updates the database or the case report forms. Conducts study visits, obtains and documents information within the time frame specified. Research, collects, compiles and conducts preliminary analyses of data, statistics, and other materials for reports. Conduct preliminary analysis.
Recruitment - Screens potential patients/subjects for eligibility to the study and schedules the initial visits. This may include researching and gathering information from the medical record, physician referral, and directly scheduling a visit to evaluate the patient/subject. Reviews all the elements of the screening process with the Principal Investigator that include but not limited to: inclusion/exclusion criteria, completed informed consent, documentation of the event and the patient/subject willingness to participate in the study.
Clinical Competency: Position will require competency in taking blood pressure, height, and weight.
Reporting and Analysis - Gathers and compiles data and assists in consolidating/analyzing data for presentation to partnering site and sponsoring agencies. Provides reports to all necessary parties (e.g., the principal investigator, partnering site, sponsoring agency, etc.) on the progress of the study as needed. Conduct primary analysis to data collected. Formulates, prepares database and generates preliminary measurement reports for review by the PI.
- 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:
Clinically trained, e.g., as a nurse, physical therapist, occupational therapist, or exercise therapist.
Required Skill/Ability 2:
Experience working in human subjects research. Ability to reliably produce accurate work, work independently, effectively and efficiently under pressure, and to multitask, juggling competing research demands with limited supervision. Demonstrated ability to oversee and coordinate research projects.
Required Skill/Ability 3:
Ability to think creatively and solve problems effectively. Ability to operate research-related equipment.
Required Skill/Ability 4:
Strong interpersonal skills and the ability to work as a team and independently. Strong organizational skills and attention to detail. Ability to multitask. Ability to effectively communicate with all levels of the organization.
Required Skill/Ability 5:
Proficiency in using various Microsoft Office applications such as Word, Excel, Access, PowerPoint and Outlook. Proficiency with electronic medical record system EPIC. Familiarity with online platforms such as Zoom.
Preferred Education, Experience and Skills:
Experience with mobile health platforms. Experience with recruitment of hospitalized patients, particularly older adults.
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.
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: email@example.com.
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