Research Associate 2 HSS

Position Focus :

The Clinical Research Associate position is intended to support ongoing Yale Inflammatory Bowel Disease Program and Yale Motility Program clinical trials and research initiatives at Yale University.

The Clinical Research Associate will be responsible to perform tasks including database entry, patient recruitment, patient engagement, and regulatory submissions, and other clinical research related studies under the supervision of the Principal Investigator (PI).

Ensures accurate compilation, analysis, and presentation of data results. Recommends the design and implementation of procedures and protocols.

Interacts with internal contacts including the PI, research assistants, graduate students. Interacts with external contacts such as researchers at other institutions, staff at biotechnology and reagents companies to consult on research methods and to keep abreast of product information and developments.

Communicates protocol related activities with participants. The best candidate for this position would have an extensive background in clinical trials with a demonstrated knowledge of medicine and biology.

This education would allow the candidate to comprehend and interpret laboratory work received and permit the candidate to fully understand the research being conducted.

This clinical knowledge will also assist the candidate in determining which subjects would be best suited for the trials when recruiting patients.

The Clinical Research Associate will be required to create original HIC and IRB submissions; collaborate with principal investigators and the creation and maintenance of all scientific protocols based on previous knowledge;

implement any protocol changes; design and implement quality control measures to ensure the accurate collection 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 demonstrated experience or an equivalent combination of education and demonstrated experience.

Required Skill / Ability 1 :

Demonstrated oral and written communication skills.

Required Skill / Ability 2 :

Proven ability to work independently and efficiently while multitasking and managing competing research demands.

Required Skill / Ability 3 :

Demonstrated organization skills with the ability to function underline pressure.

Required Skill / Ability 4 :

Ability to ensure accurate compilation, analysis, and presentation of data results.

Required Skill / Ability 5 :

Ability to have, obtain, and maintain HRPP certification for human research activities.

Preferred Education, Experience and Skills :

Strong Knowledge on all human subject regulations as defined by Yale University and the federal government that pertain to research studies.

Knowledge of submitting original HIC / IRB submissions.

Weekend Hours Required?

Occasional

Evening Hours Required?

Occasional

Drug Screen

Health Screening

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

The University maintains policies pertaining to COVID-19. All faculty, staff, students, and trainees are required to comply with these policies, which may be found here :

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.