Research Assistant II

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 ability to work independently in all phases of clinical research. Must comply with hospital regulatory requirements, NIH Guidelines, and HIPAA regulations.

Responsibilities include supporting CICU investigators in all of the 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, 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. Principal responsibilities include but are not limited to:

• Develops, implements, and maintain databases (e.g. REDCap, StudyTrax) 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 presents regular and ad-hoc study progress reports for weekly meetings, and study sponsors.
• Participates in regular meeting with QI and project teams
• Contributes to preparation of abstracts and manuscripts for publication.
• Actively responsible for the recruitment of study subjects. This includes developing and implementation of recruitment strategies, telephone screening of potential subjects, 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. Maintain case report forms, regulatory binders, perform follow-up contacts, and maintain meticulous study records. Obtain and process biological samples according to protocol after completing any necessary training.
• Drafts corrective action plans for any issues identified through QC. Ensures 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 and minutes kept and distributed. Hosts site visits. Negotiates study timelines and keeps team members accountable.

Cardiovascular experience preferred.