Clinical Research Assistant I

Status

Full-Time

Standard Hours per Week

40

Job Posting Category

Research

Job Posting Description

General Summary

Under immediate supervision, coordinates the activities of daily operations of clinical research studies. Screens, consents, recruits, and selects patients for studies. Prepares IRB and/or CCI documentation and submissions in conjunction with the Principal Investigator and /or other members of the research team. Conducts data collection activities and prepares analytical reports regarding results of studies

As part of the Gene Therapy Program, the Clinical Research Assistant will assist with clinical research operations for investigator-initiated and industry-sponsored gene and cell therapy clinical trials for patients with rare and genetic disorders. Gene Therapy Program | Boston Children's Hospital
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Principal Duties & Responsibilities

• Consents and recruits patients for research studies through personal interviews and written communications with patients/families.
• Provides detailed background information regarding studies to families, communicates all policies and procedures, and responds to all inquiries.
• Evaluates suitability of prospective study candidates and makes selections based upon clinical knowledge of each study.
• Serves as liaison to the families/patients in the research studies, conducted at both on site and off site locations, guiding and advising them throughout each phase of the study.
• Coordinates follow up visits as necessary.
• Acts as a resource to study participants, addressing any concerns they may have.
• Troubleshoots resolution of any issues that may arise throughout the study. Coordinates and prepares the necessary documentation for Institutional Review Board IRB and Committee on Clinical Investigations CCI submissions, together with the Private Investigator of the study.
• Creates and prepares data collection statistical reports and analytical summaries for distribution to study research team for review and analysis.
• Writes articles and summary papers of studies for submission to medical journals, as may be necessary/requested.
• Participates in the training of newly hired research study assistants, as required.
• Coordinates activities between the hospital and research laboratories to ensure correct testing/processing and send out instructions specific to the study.
• Communicates project policies and procedures to personnel.
• Monitors and reviews data collection and data entry, and informed consent procedures ensuring consistency of application for each study.
• Performs other miscellaneous administrative duties as assigned or required.

To qualify, you must have a Bachelor’s degree in a related field, a high attention to detail and organizational skills, ability to multi task, analytical skills to gather and interpret data, and well developed communication skills.

Office/Site Location

Brookline

Regular, Temporary, Per Diem

Regular

Remote Eligibility

Part Remote/Hybrid