78456BRJob Posting Title:Clinical Research Specialist I - UrologyDepartment:UrologyAutoReqId:78456BRStatus:Full-TimeStandard Hours per Week:40 Job Posting Category:ResearchJob Posting Description:This Clinical Research Specialist I will be responsible for: + Assisting Principal Investigators 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 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 and screening study participants for eligibility on the phone, in the hospital, and other settings. 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. Updating protocol and amendment changes as needed + Assisting investigators in data and/or document preparation for journal publication. Performing literature searches and pulling articles To qualify, you must have: + A Bachelor’s degree is required. Masters level degree preferred but not required + A minimum of 1-3 years of relevant work experience is required + The analytical skills to gather and interpret data in which the information or problems are moderately complex to complex + Well-developed communication skills in order to provide critical information to patients, effectively deal with conflicting views or issues, and the ability to mediate fair solutions + Advanced writing skills 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.Office/Site Location:BostonRegular, Temporary, Per Diem:Regular Remote Eligibility :Part Remote/Hybrid