POSITION SUMMARY/ DEPARTMENT SUMMARY:

Under general supervision, the Clinical Research Assistant working in the Heart Center Clinical Research Program will coordinate daily operations of:

• Several projects involving the recruitment of patients in our outpatient Cardiology Clinic. The candidate would have to identify eligible patients, approach them in clinic, and consent patients to multiple different studies.
• Additional studies include the care and follow-up of patients born with congenital heart disease (CHD), focusing on their care in early stages of life and follow-up for adolescents with CHD. This is with a group called the Pediatric Heart Network (PHN), which includes many Cardiologists at Boston Children’s Hospital and other centers across North America.

This is a two-year position with the goal of providing the incumbent with the skills and experience to further their career in medicine. The position will provide opportunities to be included in the publication of manuscripts.

Key Responsibilities:

• Assists Principal Investigators (PIs) in developing and implementing new clinical research studies and in executing ongoing research studies.
• Coordinates and prepares new protocol applications for submission to the Heart Center’s Scientific Review Committee, the Boston Children’s Hospital IRB, and our central IRB. Prepares and submits continuing reviews and protocol amendments to the IRB for ongoing studies. Corresponds with the IRB.
• Coordinates weekly meetings with the research teams, including creating the meeting agenda and writing summary documents.
• Recruits study participants for enrollment in clinical research studies, including obtaining informed consent on interested patients.
• Expected to be in-person 4-5 days per week and able to attend satellite clinics to recruit patients a few times per month.
• Completes data collection through medical record review or through patient visits (study-dependent). Enters clinical data into existing databases in accordance with best practice methods.
• Maintains regulatory binders, case report forms, source documents, and other study documents.
• Complies with all institutional policies and government regulations pertaining to human subjects protections.

MINIMUM QUALIFICATIONS

Education:

• Bachelor’s Degree required, and a background in university-level science courses would be helpful.

Experience:

• Prior experience conducting clinical or basic research is preferred, but not required

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. Experience the benefits of passion and teamwork.

• Assists Principal Investigators (PIs) in developing and implementing new clinical research studies and in executing ongoing research studies.
• Coordinates and prepares new protocol applications for submission to the Heart Center’s Scientific Review Committee, the Boston Children’s Hospital IRB, and our central IRB. Prepares and submits continuing reviews and protocol amendments to the IRB for ongoing studies. Corresponds with the IRB.
• Coordinates weekly meetings with the research teams, including creating the meeting agenda and writing summary documents.
• Recruits study participants for enrollment in clinical research studies, including obtaining informed consent on interested patients.
• Expected to be in-person 4-5 days per week and able to attend satellite clinics to recruit patients a few times per month.
• Completes data collection through medical record review or through patient visits (study-dependent). Enters clinical data into existing databases in accordance with best practice methods.
• Maintains regulatory binders, case report forms, source documents, and other study documents.
• Complies with all institutional policies and government regulations pertaining to human subjects protections