Boston, MA

The Clinical Research Specialist I will be responsible for:

• Assisting Principal Investigators (PIs) in planning and implementing clinical research studies as assigned. Under the direction of the PI, coordinating preparation of protocol applications for submission to the IRB, sponsor or regulatory authority. As directed by the PI corresponding with the IRB, study sponsors, clinical research organizations, study participants and referring physicians.
• Recruiting study participants for enrollment in clinical trials. Following individual study protocols. Completing informed consent procedures as assigned. Organizing strategies for recruiting study participants, screening study participants for eligibility on the telephone, in the clinic and other settings as required. Completing follow up with study participants in prescribed settings as required.
• Organizing study procedures and scheduling study participants for study visits. Assisting the PI during patient visits. Performing study procedures designated for the Study Coordinator.
• Completing record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods. Conducting a QC check of completed CRFs prior to submission for data entry; coordinating resolution of all data queries. Completing data entry as warranted.
• Complying with all institutional policies and government regulations pertaining to human subjects protections. Maintaining regulatory binders, case report forms, source documents, and other study documents. Monitoring the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Committee on Clinical Investigations (IRB). Updates protocol and amendment changes.
• Assisting investigators in data and/or document preparation for journal publication. Performing literature searches and pulling articles.

To qualify, you must have:

• Bachelor's degree, and a minimum three years of relevant work experience or Masters of Science and one year of relevant work experience Master of Public Health (MPH) degree preferred.

Boston Children’s Hospital offers competitive compensation and unmatched benefits, including a rotating days/evenings and week-end schedule, affordable health, vision and dental insurance, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition Reimbursement, cell phone plan discounts and discounted rates on T-passes (50% off). Discover your best.
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