The Division of Electrophysiology (EP) within the Benderson Family Heart Center at Boston Children's Hospital is seeking a full time Clinical Research Specialist II (CRS) to lead daily operations of the Division's clinical research protocols and Quality Improvement (QI) initiatives.
The EP Division is a dynamic team of physicians, nurses, and technologists specializing in pediatric heart rhythm disorders. Ongoing research involves core laboratories, clinical trials (multi-center collaborations, NIH and industry funded studies), and QI studies. As one of the largest EP programs in the country, our physician-investigators lead the field in ground-breaking research including understanding of the mechanism of arrhythmia in children, artificial-intelligence for identification of high-risk patients, pacemakers and defibrillators and the management of arrhythmias in adults with congenital heart disease.

This Clinical Research Specialist will be responsible for:

• Leads and coordinates the work of multiple clinical research trials/studies/registries including: Regulatory submissions and maintenance; Trial/Study set-up; Participant selection; Database design and maintenance; Data collection/audit; Equipment and materials management; Coordination of study visits; Data Analysis; and Dissemination of results.
• Develops and implements best practice guidelines and Standard Operating Procedures (SOP) for maintaining data quality and research infrastructure across various types of clinical research protocols (trials, studies, registries).
• Collaborates and consults with Principal Investigators (PI), study teams, and study stakeholders on the design, development, and conduct of clinical research trials (Phase 1 and Phase 2), clinical research studies, and clinical research programs.
• Collaborates with Principal Investigator and other scientific staff in financial sustainability activities: developing and writing grants and research proposals for target audience; seeking philanthropic support.
• Coordinates communication between study staff and internal and external stakeholders.
• Organizes and facilitates internal team meetings and external stakeholder meetings.
• Hires, trains, and supervises research staff and conducts Performance Management process in collaboration with PIs. May develop and implement program-specific on-boarding and ensures all staff complete required hospital training. May supervise interns and medical students.
• Monitors program budget, maintains financial records, establishes and maintains research billing schedule, and ensures compliance with hospital and governmental regulations.
• Ensures all work is performed in conformance with established program, hospital, state, and federal policies and procedures.

In order to qualify, you must have:

• Bachelor's degree and 4 years of research and/or clinical experience. Master's degree in Public Health, Healthcare Management or a closely related field and 2 years of relevant experience is preferred.

Knowledge, Skills, and Abilities:

• Must be able to perform day-to-day responsibilities with minimal supervision.
• Strong interpersonal communication and effective problem-solving skills are required.
• The analytical skills to resolve complex problems requiring the use of scientific, mathematical, or technical principles and in depth, experienced based knowledge.
• Must have advanced writing skills.
• Must have computer skills including the use of the Microsoft Office Suite and working knowledge of electronic health record platforms and commercial electronic data capture applications.