Boston Children's Hospital is seeking a Clinical Research Assistant to assist with clinical research projects focusing on Angelman syndrome. The role involves coordinating clinical studies, recruiting participants, and managing study documentation under the supervision of the Principal Investigator.
Responsibilities
- 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
Skills
- 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
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