Position Summary
This position supports the Department of Neurosurgery’s clinical research efforts. The department conducts numerous ongoing clinical trials, investigator-initiated studies, and retrospective research projects. The Clinical Research Coordinator is responsible for maintaining subject and regulatory binders for clinical trials and prospective studies.

The ideal candidate has clinical research experience, patient-facing experience, and is interested in building a career in research administration. Additional responsibilities include supporting research assistants in their day-to-day activities, providing training, managing logistics and operations, assisting with problem-solving, supporting IRB efforts, and performing other administrative duties for the research team.

This role is not limited to supporting a specific Principal Investigator (PI) or disease area within Neurosurgery. Instead, the Clinical Research Coordinator will support clinical research studies across the full spectrum of the department’s research portfolio.

Key Responsibilities

• Responsible for the daily operations of research studies across the department, implementing processes and procedures to meet goals and protocol requirements. Serves as a resource for onboarding and training new Clinical Research Assistants, providing instruction on study roles, responsibilities, workflows, and required tasks to ensure consistency and adherence to protocol requirements. Develops and maintains study-related training materials as needed in collaboration with the Principal Investigator and/or designee.
• Consents and enrolls patients for studies by providing detailed information on the clinical study to prospective participants and families. Is responsible for understanding and adhering to all policies and procedures and responds to all inquiries. Evaluates the suitability of study candidates and makes selections based on clinical knowledge of each study. Provides input for updates of SOPs and drafting of new quality documentation.
• Coordinates and prepares with minimal supervision the necessary documentation for Institutional Review Board (IRB) and external stakeholders on submissions and track progress to review and approval.
• Serves as liaison between local study sites and Clinical Coordinating Center regarding study procedures and operations and protocol interpretation. Maintains regulatory binders and all study documentation, monitors adverse events and reporting thereof. Assists with protocol amendments, and other regulatory activities.
• Creates tracking systems and assists with developing processes to enhance efficiency and effectiveness of study operations and data management, such as patient appointment scheduling, as well as completion and tracking of study data and forms.
• Create and prepare data collection statistical reports and analytical summaries for distribution to the study research team for review and analysis. May write articles and summaries of studies for submission. May present study results at local and national meetings.
• Assists in preparing scientific abstracts and manuscripts for publication in academic journals. May assist Principal Investigator or designee in preparing new applications for research funding and in developing, implementing, and managing ancillary study grants.

Minimum Qualifications
Education:

• Bachelor’s degree

Experience:

• 2 years of relevant experience