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Clinical Research Specialist I- Otolaryngology

2 months ago


Boston, United States Boston Children's Hospital Full time
Job Posting Description

This research assistant position offers an incredible opportunity to build research and project management skills that will benefit any future career path. The research assistant will work closely with two pediatric otolaryngologists on projects related to pediatric swallowing, congenital malformations of the nose and throat, chronic rhinosinusitis, and smell function. This position offers tremendous education on the research process, database creation and management, statistics, and manuscript writing. In addition, this role offers the opportunities to collaborate with a diverse group of clinical professionals and to attend medical conferences within the department and nationally.

This Clinical Research Specialist will be responsible for:
  • Assists 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.
  • Recruits 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.
  • Organizes study procedures and schedules study participants for study visits.
  • Assists the PI during patient visits.
  • Performs study procedures designated for the Study Coordinator.
  • Completes 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.
  • Complies 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.
  • Assists investigators in data and/or document preparation for journal publication. Performs literature searches and pulls articles.
In order to qualify you must have:
  • a minimum of a Bachelors Degree in STEM with 3 years of work experience OR a Masters Degree and 1 year of 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. Experience the benefits of passion and teamwork.

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