74509BRJob Posting Title:Clinical Research Assistant IDepartment:Medicine-GeneticsAutoReqId:74509BRStatus:Full-TimeStandard Hours per Week:40 Job Posting Category:ResearchJob Posting Description: The Division of Genetics and Genomics at Boston Children’s Hospital is seeking Clinical Research Assistants to assist with clinical research projects that focus on Angelman syndrome in both children and adults. These projects include a nationwide multi-center natural history study for which our team serves as the sponsor and lead study site, and multiple industry-sponsored clinical trials.

The responsibilities of this position may include, but are not limited to:

• 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.

• Coordinating off-site visits, including travel arrangements; attending off-site 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

• This position may offer candidates an opportunity to shadow physicians and other healthcare providers in an academic medical center.

  Minimum Qualifications:

• Bachelor’s degree from an accredited 4-year college or university with a major in the sciences, engineering, mathematics, or psychology

• 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

  Preferred Qualifications:

• At least one semester of basic science or clinical research experience

• Defended an honors thesis or equivalent

• Previous leadership position in student or community organizations

• A 2-year commitment to this position

  Office/Site Location:BostonRegular, Temporary, Per Diem:Regular Remote Eligibility :Part Remote/Hybrid