Clinical Research Assistant I-IMPACT Registry & Cath Lab

Under general supervision, the Clinical Research Assistant working in the Heart Center Clinical Research Program will coordinate daily operations of:
* Cath divisional research projects including FDA-regulated clinical trials for devices placed during cardiac catheterization procedures to treat congenital heart defects and other projects. The CRA will be responsible for patient outreach and recruitment, data entry, and trial coordination.
* Institutional case contribution to a national external registry on cardiac catheterization and electrophysiology procedures to treat congenital heart defects.

This position working with Dr. Diego Porras, MD; Dr. Nicola Maschietto, MD, PhD; Dr. Brian Quinn, MD, and other physicians in the cardiac catheterization laboratory prefers a minimum 2-year commitment to provide the employee with the skills and experience to further a career in medicine or clinical research.

This Clinical Research Assistant will be responsible for:

• In collaboration with supervisor, develops and implements systems to manage study operations, data collection, and patient recruitment while meeting data collection targets and adhering to human protection and good clinical practice guidelines.
• Assists Principal Investigators (PIs) and other member of the research team in developing, implementing, and managing new and ongoing clinical research studies.
• Completes high-quality, accurate data collection through medical record review. Enters data into databases in accordance with best practice methods and maintains accurate, up-to-date and organized study records.
• In collaboration with supervisor and PI, data collection activity including REDCap database design and management, data entry and cleaning, basic quantitative analyses, table and figure creation, literature reviews, writing and editing drafts, manuscript preparation for submission, and other related duties as requested.
• Is the initial contact for the Institutional Review Board. Prepares new protocol applications for the Heart Center Scientific Review Committee and Boston Children's Hospital IRB. Prepares and submits continuing reviews and protocol amendments to the IRB for ongoing studies.
• Complies with institutional policies and government regulations on human subject protections.
• Maintains an organized working environment. Demonstrates the ability to work independently and collaboratively. Establishes and meets deadlines.
• Performs other miscellaneous administrative duties and participates in the training of newly hired research study assistants, as required.

In order to qualify, you must have:

• A bachelor's degree is required, a background in university level science courses is preferred.
• Research skills and the ability to work independently are essential.
• Excellent organizational and communication skills, and the ability to keep meticulous records are required.
• Prior experience in clinical research and IRB preparation is preferred.
• Knowledge of Microsoft Office and Zoom/Microsoft Teams and the ability to learn individual protocol-specific software and web-based systems (i.e., REDCap) are strongly preferred.

Boston Children's Hospital offers competitive compensation and unmatched benefits including flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes.