Clinical Research Coordinator

Employment Duration: 6 months

The Neuro-Oncology Service of the Department of Neurosurgery is a referral, recommendation, and treatment service for adult patients with central nervous system tumors (primary brain tumors). The Neuro-Oncology Service Clinical Trials Program includes pharmaceutical industry-sponsored studies, investigator-initiated studies in collaboration with outside universities and NCI cooperative groups, and SPORE grants for cancer research. Qualified research staff support Principal Investigators in conducting research in accordance with Good Clinical Practice.

Under the supervision of the Clinical Research Coordinator Supervisor and Research RN Manager, the Clinical Research Coordinator collects and enters protocol patient data for the management of Neuro-Oncology clinical trials. The incumbent manages patients on active and follow-up studies based on study complexity and performs duties including patient enrollment and follow-up, data collection and entry, specimen processing, regulatory support, quality control, and coordination of research activities. The position also supports study start-up activities by preparing and submitting regulatory documentation, reviewing consent forms, and developing internal study documents while following established guidelines and standard operating procedures.

Key Responsibilities:

• Coordinate study start-up activities and serve as a liaison among the Principal Investigator, study sponsors, the Helen Diller Family Comprehensive Cancer Center, and study team members.
• Assist with protocol preparation and Institutional Review Board (IRB) submissions.
• Participate in developing protocol and consent form templates.
• Assist in the development and maintenance of departmental Standard Operating Procedures (SOPs).
• Develop and standardize systems for clinical trial oversight and quality assurance.
• Plan clinical practice activities with research leadership and Principal Investigators prior to protocol implementation.
• Design, implement, and manage systems to organize and maintain clinical research workflows.
• Maintain study protocols through amendments, renewals, and regulatory updates.
• Prepare and submit protocol modifications and annual renewals in accordance with regulatory requirements.
• Verify patient eligibility through review of medical history and source documentation.
• Coordinate required laboratory work, MRI scans, and other protocol-required procedures.
• Collect, retrieve, and enter study data into required databases and case report forms.
• Gather laboratory results, imaging reports, cardiology reports, and other protocol-specific data.
• Submit information regarding toxicities and adverse events in a timely manner.
• Obtain, process, handle, and ship blood and tissue specimens.
• Maintain accurate research patient charts, study binders, and regulatory files.
• Monitor inventory of study supplies and reorder materials as needed.
• Manage patient follow-up according to protocol requirements.
• Respond to inquiries from research professionals and prospective research participants.
• Perform neurocognitive assessments and other direct patient, non-therapeutic research activities as assigned.
• Support planning and implementation of research information systems, including OnCore.
• Provide study accrual reports and serve as a resource for Principal Investigators regarding data management.
• Develop systems to ensure protocol adherence and data quality.
• Ensure compliance with federal regulations, Good Clinical Practice (GCP), and institutional requirements.
• Review study forms and patient charts for completeness, accuracy, and protocol compliance.
• Monitor the timeliness of data submission.
• Coordinate adverse event and serious adverse event documentation and reporting.
• Attend site initiation and sponsor monitoring visits.
• Coordinate external sponsor and regulatory audits and prepare required documentation.
• Prepare and edit protocols and consent forms for regulatory submission.
• Submit protocols to appropriate committees and maintain regulatory documentation.
• Assist with protocol modifications, amendments, and study closeout activities.
• Perform other related duties as assigned.