Position Summary/ Department Summary:
The Heart Center Clinical Research Program at Boston Children’s Hospital is seeking a Clinical Research Assistant (CRA). The CRA in this position will interact with a variety of investigators from the Benderson Family Heart Center (Cardiology, Cardiac Surgery and Cardiovascular Nursing), and the inpatient/outpatient Cardiology Clinic. Research activities may involve but are not limited to regulatory submissions, data abstraction from the medical record, data and specimen coordination, study preparation, and patient screening and patient contacts both in person and by phone.
Additionally, the CRA will be responsible for all tasks associated with two (2) ongoing research protocols: one protocol involving the collection of biospecimen samples from Heart Center Patients and the other protocol involving patients diagnosed with pulmonary hypertension. Activities for both protocols include screening and consenting eligible patients, collecting and entering data into study databases, and coordinating all regulatory submissions.
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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.
• Coordinate 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.
• Complete data collection through medical record review or through patient visits (study-dependent). Enter clinical data into existing databases in accordance with best practice methods.
• Maintains regulatory binders, case report forms, source documents, and other study documents.
• Comply 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.
• The successful candidate will be adaptable, skilled with multi-tasking, have strong written and oral communication skills and excellent attention to detail.

Experience:

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