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The Division of Genetics and Genomics at Boston Children’s Hospital is seeking a Clinical Research Assistant to assist with clinical research projects that focus on Angelman syndrome in both children and adults. These projects include multiple industry-sponsored clinical trials and a longitudinal natural history study.
Job Responsibility:
Assisting Principal Investigator (PI) in planning and implementing clinical research studies as assigned, including: coordinating preparation of protocol applications for submission to the IRB, study sponsor, regulatory authority, etc.
corresponding with the IRB, study sponsors, clinical research organizations, study participants, and referring physicians
Recruiting study participants for enrollment in clinical studies, including organizing strategies for recruiting study participants, screening study participants for eligibility, and completing informed consent procedures
Organizing study procedures and scheduling study participants for study visits. Assists the PI during study visits
Completing record abstraction of source documents, conducting required study measurements and completing study Case Report Forms (CRFs)
conducting a QC check of completed CRFs prior to submission for data entry
coordinating resolution of all data queries
Maintaining regulatory binders, case report forms, source documents, and other study documents
monitoring the occurrence of adverse events and reporting to the PI, the study sponsor and the IRB, if any
Under the supervision of the PI, work with study staff to prepare for monitoring and audits by independent monitors, sponsors, and other regulatory agencies
Collection or processing of study specimens, delivery to appropriate labs or packaging and shipping to appropriate facilities
Assist PI and other study staff with conference presentations and manuscripts by extracting and compiling data from investigator-initiated studies
Requirements:
Bachelor’s degree
Strong quantitative and analytical skills
comfortable with numbers
Interested in working with children and adults with severe physical and intellectual disabilities, and their families
Excellent interpersonal as well as oral and written communication skills
Willingness to work flexible hours, as and when required
What we offer:
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