Research Associate 2, HSS

Overview

Participates in the coordination, administration and ongoing management of clinical trials and observational studies within the Rheumatology department. Contributes to study design implementation and independently manages key components of study operations, including patient recruitment, protocol-driven visit coordination, and alignment of study activities with sponsor-required schedules. Responsible for maintaining high-quality data across multiple platforms, including REDCap, Epic, and sponsor electronic data capture (EDC) systems, with a focus on data accuracy, query resolution, and protocol compliance. Assists in regulatory processes, including IRB/WCG submissions, amendments, and maintenance of study documentation to ensure adherence to institutional, federal, and sponsor requirements. Supports biospecimen workflows and biorepository activities, including coordination of specimen collection, processing, tracking, and storage in accordance with established protocols. Collaborates closely with investigators, study teams, and sponsors to facilitate study progress, communicate updates, and address operational needs. Contributes to data analysis, manuscript preparation, and presentation development by assisting with data pulls, organization of datasets, and preparation of research materials. Provides guidance to junior staff and supports overall team operations to ensure efficient and compliant execution of clinical and translational research activities.

Required Skills and Abilities

1. Ability to support clinical research activities, including participant interaction, data collection, and adherence to established study protocols and regulatory guidelines.
2. Proficiency in accurate data entry and basic data management using systems such as REDCap, Epic, or other EDC platforms, with attention to data quality and completeness.
3. Strong interpersonal skills with the ability to interact professionally with research participants, clinical teams, and study staff.
4. Strong attention to detail and ability to manage multiple tasks across studies, including tracking study activities, timelines, and documentation requirements.
5. Working knowledge of Microsoft Office applications and general research tools; ability to learn and navigate clinical research systems and databases.

Preferred Skills and Abilities

1. Master's degree in a related field (e.g., public health, social sciences).
2. Proven experience preparing IRB protocols, amendments, and progress reports.
3. Proven experience with clinical trials, including patient recruitment and regulatory submissions.
4. Familiarity with statistical analysis software (e.g., SPSS, SAS, R).
5. Prior experience working on large-scale research studies or multi-visit projects.

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.