Research Associate 2 HSS

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Salary Range

$65,000.00 - $101,000.00

Overview

In the Department of Pediatrics, these research studies focus primarily on aortic disease and the associated genetic conditions. The Research Associate initiates and conducts protocol review, evaluations, study design and risk assessments of clinical research studies. Responsible for developing informational materials for the recruitment of subjects, monitoring enrollment goals, and modifying recruitment strategy as needed. Identifies and selects potential subjects, screens subjects, enrolls subjects, performs subject interviews and assessments for data as required by protocol(s), and collects and manages subjects data and biospecimens. The Research Associate oversees and ensures compliance with regulations, prepares and submits IRB documents and prepares regulatory documents for the sponsor. Additional responsibilities include review of incoming subject adverse event (SAE) information, assisting the PI in making submission determination of SAEs and follow up to determine resolution of adverse events. The position also conducts study-related non-medical/behavioral assessments/interventions and is responsible for records, documents and reports on protocol deviations and trial changes to the PI and sub-investigators. Must stay up to date on knowledge of regulatory affairs. Ensures that key personnel are compliant with Conflict of Interest, Human Subject, Animal, Safety, HIPAA and other training mandates. Ensures the timely and accurate entry of sponsored award data into the University's electronic data tracking systems (GPAS, INFOED or other similar systems). May perform other duties as assigned.

Required Skills and Abilities

1. Experience with regulatory and IRB process, as well as protocol development.

2. Excellent written and verbal communication skills, with strong attention to detail.

3. Proven experience conducting and supporting all phases of clinical research, including data management and analysis.

4. Strong organizational skills, with the ability to multitask, prioritize tasks, and manage time effectively.

5. Demonstrated ability to work both independently and as part of a multidisciplinary team.

6. Proficiency in Microsoft Office Suite and experience with electronic data collection tools.

7. Demonstrated ability to identify and resolve problems and ability to make sound judgement in the area of specialization.

8. Demonstrates a high commitment to quality.

Preferred Skills and Abilities

Demonstrated excellence working with faculty, staff, study subjects and building strong partnerships, relationships and working collaboratively.

Principal Responsibilities

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.

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.

Health Requirements

This role is a healthcare worker position. Healthcare workers (HCW) are defined as university employees working a healthcare setting who have the potential for direct or indirect exposure to patients, human research subjects or infectious materials including body substance, contaminated medical supplies, devices and equipment, surfaces, or air. HCW have specific health requirements that must be met prior to starting work, including MMR vaccine or immunity, varicella (chickenpox) vaccine or immunity, TB screening, COVID vaccine according to University policy, hepatitis B vaccine or immunity, and annual flu vaccination.

Posting Disclaimer

Salary offers are determined by a candidate's qualifications, experience, skills, and education in relation to the position requirements, along with the role's grade profile and current internal and external market conditions.

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 position. Employees will be assigned specific job-related duties through their hiring department.

The University is committed to basing judgments concerning the admission, education, and employment of individuals upon their qualifications and abilities and seeks to attract to its faculty, staff, and student body qualified persons from a broad range of backgrounds and perspectives. In accordance with this policy 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).

Note

Yale University is a tobacco-free campus.