77356BRJob Posting Title:Clinical Research Specialist IDepartment:Research-Clinical Research Core ProgramsAutoReqId:77356BRStatus:Full-TimeStandard Hours per Week:40 Job Posting Category:ResearchJob Posting Description:The Clinical Research Operations Center supports both investigator-initiated and industry-sponsored clinical research studies across Boston Children’s Hospital. Our team includes project managers, research coordinators, research nurses and NPs, and more. We work in a highly collaborative and supportive atmosphere to provide excellent clinical research support to BCH investigators. This position offers an opportunity for education and professional development in all areas of clinical research. 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, coordinates preparation of protocol applications for submission to the IRB, sponsor, or regulatory authority. As directed by the PI corresponds with the IRB, study sponsors, clinical research organizations, study participants, and referring physicians.
Recruiting study participants for enrollment in clinical trials. Follows individual study protocols. Completes informed consent procedures as assigned. Organizes strategies for recruiting study participants and screens study participants for eligibility on the telephone, in the clinic, and other settings as required. Completes follow-up with study participants in prescribed settings as required.
Organizing study procedures and schedules study participants for study visits. Assists the PI during patient visits. Performs study procedures designated for the Study Coordinator.
Completing record abstraction of source documents, conducts required study measurements, and completes study Case Report Forms in accordance with best practice methods. Conducts a QC check of completed CRFs prior to submission for data entry; coordinates resolution of all data queries. Completes data entry as warranted.
Complying with all institutional policies and government regulations pertaining to human subjects' protections. Maintains regulatory binders, case report forms, source documents, and other study documents. Monitors 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. Performs literature searches and pulls articles.
In order to qualify, you must have:
Bachelor’s degree with 3 years of relevant work experience OR Master’s degree and 1 year of relevant work experience; Team also open to hiring Clinical Research Assistant II which only requires Bachelor’s degree and 1 year of post undergraduate experience.
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. #LI-Hybrid Office/Site Location:BostonRegular, Temporary, Per Diem:Regular Remote Eligibility :Part Remote/Hybrid