Clinical Research Assistant

Position Summary

Under direction of Clinical Nephrology Team and Faculty, this individual will assist with studies of children with kidney disease. Responsible for screening patients for trial participation, enrolling patients, following protocol implementation, completing required forms, reporting results and regulatory submission. Creates study‑specific data collection and statistical and analytical reports. Responsible for assisting in clinical studies as members of the team and will work closely with multidisciplinary teams and participate in subject research activities throughout the studies.

May assist in writing articles and summarizing papers for submission.

• 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.

• Bachelor’s Degree in STEM, Psychology or a related field is required.

• Analytical skills to gather and interpret data, excellent organizational skills and attention to detail.
• Effective communication and writing skills to provide critical information to team members, patients, and families with ability to triage and elevate concerns to appropriate leadership.
• Problem‑solving, troubleshooting abilities and resourcefulness.