Clinical Research Associate, Pediatrics Diabetes

09-Sep-2022

Pediatrics – Endocrinology

76452BR

University Job Title

Research Associate 2, HSS

Bargaining Unit

None – Not included in the union (Yale Union Group)

Compensation Grade

Clinical & Research

Compensation Grade Profile

Research Associate 2 HSS (23)

Wage Ranges

Click here to see our Wage Ranges

Work Location

Medical School Campus

Worksite Address

789 Howard Avenue
New Haven, CT 06519

Work Week

Standard (M-F equal number of hours per day)

Searchable Job Family

Clinical, Research Res Support, Research/Support

Total # of hours to be worked:

37.5

Position Focus:

Reporting to the TrialNet principal investigator, independently, and in collaboration with the research team, manage scheduling and follow up with families involved in research studies in addition to performing other study related procedures.  Participate in the recruitment of study participants for research protocols, evaluating the participants for inclusion in protocols; based on knowledge of protocol and study requirements, coordinate operation of study protocols with the investigators and other members of the study team define the parameters and eligibility criteria for study enrollment in order to guide the clinical team in identifying viable research candidates; obtain informed consent; responsible for the creation maintenance of accurate data records, report adverse events to the study and clinical teams; manage study supply provision; educate participants in the use of study devices based on the knowledge and understanding of these devices; assist researchers in preparation of manuscripts; participate actively in research meetings, presenting information and updates as required; participate in conference calls with the coordinating center regarding study conduct; consult with families and with research coordinating centers using knowledge, understanding ; provide feedback to coordinating center for protocol development and revision; interact with both internal and external contacts regarding clinical trials; adheres to quality control measures to ensure accurate collection and processing of data.

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:

Prior experience in clinical trials with demonstrated ability to assess inclusion/exclusion criteria, familiarity with the consenting process, good interpersonal skills to allow for successful relationships with participants.  Prior conduct of multicenter clinical trials would aid with integration into the clinical research infrastructure for this position.

Required Skill/Ability 2:

Demonstrated experience with use of electronic medical records for research including the ability to screen potential participants for eligibility as well as extract data needed for study purposes.

Required Skill/Ability 3:

Demonstrated experience in and ability to critically evaluate patient information to meet eligibility requirements.

Required Skill/Ability 4:

Demonstrated excellence in time management, organizational skills and attention to details.  Ability to work collaboratively as part of a team and also take initiative and work independently.

Required Skill/Ability 5:

Familiarity with IRB processes including the ability to develop and attain approval HIC/IRB approval of proposed trials and maintenance of ethical approvals/certification.

Preferred Education, Experience and Skills:

Phlebotomy certification preferable; Bilingual in Spanish and English; Prior experience with data collection and database management.

Weekend Hours Required?

Occasional

Evening Hours Required?

Occasional

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. For additional information on the background check requirements and process visit “Learn about background checks” under the Applicant Support Resources section of Careers on the It’s Your Yale website.

COVID-19 Vaccine Requirement

Thank you for your interest in employment at Yale University. Please also note that the university has a COVID-19 vaccination and booster requirement for all students, staff & faculty which is described in the COVID-19 Vaccine Program. As you search our open positions, you will see that all postings list their on-site addresses which gives more detail on the on-campus work location of the role.

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.

EEO Statement:

University policy is committed to affirmative action under law in employment of women, minority group members, individuals with disabilities, and protected veterans. Additionally, in accordance with Yale’s Policy Against Discrimination and Harassment, and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual’s sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.

Inquiries concerning Yale’s Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA).

W.L. Harkness Hall, 3rd Floor, Room 303

100 Wall Street, New Haven CT 06511

203-432-0849

equity@yale.edu<mailto:equity@yale.edu>

Note

Yale University is a tobacco-free campus