Clinical Research Monitoring (CRA)

General Summary
Under supervision, coordinates daily activities and operations of clinical research studies. Responsible for screening and enrolling patients, monitoring protocol implementation, completing required forms and reporting results, and regulatory submissions. Conducts data collection activities and may prepare analytical reports on study results. Follows established clinical study standards and procedures to plan and conduct clinical research studies. Maintain open communication with team members to ensure proper study progress.

Key Responsibilities

Reviews clinical information to identify patients meeting study inclusion criteria. Consents and enrolls patients for research studies by providing detailed information on the Research Study to patients and families. 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.

Is responsible for understanding and adhering to all policies and procedures and responds to all inquiries. 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 documentation needed for Institutional Review Board (IRB) on submissions, for PI approval. Conducts data collection activities and may prepare analytical reports on study results.

Tracks progress from submission to approval. Assist in developing supportive study documents such as informed consent forms, monitoring templates, study subject tracking tools, monitoring forms, study manuals, and training materials, as required for a study. Assist with the tracking and compilation of enrollment information.

May help train and orient newly hired study personnel. Coordinates activities with various departments to ensure correct testing/processing and sends clear instructions to each study. Monitors and reviews data collection and data entry, and informed consent procedures ensuring consistency of application for each study.

May assist with preparation of manuscripts and reports to be submitted to academic journals. Follows established clinical study standards and procedures to plan and conduct clinical research studies. Maintain open communication with team members to ensure proper study progress.

Minimum Requirements
Education

Bachelors Degree

Experience

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.

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