Research Assistant II

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Mass General Brigham Incorporated

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

The Research Assistant II will be involved in coordinating the clinical research activities and quality improvement data management and analysis for the Cardiac Intensive Care Unit (CICU) of the Cardiovascular Division at Brigham and Women’s Hospital. The candidate must possess the ability to work independently in all phases of clinical research and must comply with hospital regulatory requirements, NIH Guidelines, and HIPAA regulations.

Responsibilities include supporting CICU investigators in all stages of clinical research: including research initiation, regulatory (IRB) submission, care coordination of subjects, required education of staff, maintenance and adherence to the protocol, monitoring of data, and reporting to both sponsor and IRB until close‑out of each study. In addition, the Coordinator will also devote substantial effort to managing data collection and analysis for selected quality improvement initiatives linked to the CICU.

The Coordinator will function in the co‑management of clinical research and CICU database activities with the CICU Director and investigators.

• Develops, implements, and maintains databases (e.g., REDCap, Study Trax) for CICU-based projects
• Oversees the project database data management, data collection, and data quality. Reviews and analyzes data to ensure consistency, integrity, and accuracy based on project-specific guidelines
• Responsible for creating data reports and presenting regular and ad‑hoc study progress reports for weekly meetings and study sponsors
• Participates in regular meetings with QI and project teams
• Contributes to preparation of abstracts and manuscripts for publication
• Actively responsible for the recruitment of study subjects, including developing and implementing recruitment strategies, telephone screening of potential subjects, and enlisting participation by scheduling appointments and sending out necessary paperwork
• Performing study visits, including administration of consent, following procedures for study visits, and appropriate follow-up with subjects
• Collects and reviews study data, ensuring compliance with protocol and data integrity; maintains case report forms, regulatory binders, performs follow-up contacts, and maintains meticulous study records; obtains and processes biological samples according to protocol after completing any necessary training
• Drafts corrective action plans for any issues identified through QC, ensuring queries are responded to in a timely manner
• Oversees regulatory aspects of trials, including monitoring or coordinating a monitoring body, safety and protocol violation documentation as appropriate. Develops and prepares content for study IRB submissions, amendments, continuing reviews, and reports. Ensures audit-ready files are kept
• Serves as the primary contact for assigned projects for both internal and external communications. Directly responds to inquiries regarding study protocol and policy; ensures necessary meetings are held, minutes kept and distributed, hosts site visits, negotiates study timelines, and keeps team members accountable

Bachelor’s Degree in Science required. Can this role accept experience in lieu of a degree?
Yes

Cardiovascular experience required.

Relevant research and data management experience 1‑2 years required.

• Good interpersonal and communication skills
• Careful attention to detail
• Excellent organizational skills and ability to prioritize a variety of tasks
• Intermediate computer literacy including database tools
• Knowledge of data management programs
• Ability to follow directions and exhibit…