Job Summary

The Clinical Research Specialist in the Department of Neurological Surgery will work closely with a dynamic and highly engaged clinical research team members and Principal Investigators to conduct Neurosurgery protocols.

Department Specific Responsibilities

• Supports studies in the following specialty areas: Neurovascular, Neuro-Oncology, Spine, Functional, Traumatic Brain Injury.
• IRB and regulatory documentation submission and maintenance.
• Administers informed consent to patients and their Legally Authorized Representatives, data entry, liaison with study sponsors, addressing queries, data entry, RedCap database development, and conducting study subject visits.

General Responsibilities

• Assists with identifying and recruiting potential research study subjects; determines eligibility according to the IRB/protocol approved methodologies, coordinates study procedures, and monitors the progress of research studies or projects.
• Conducts study visit activities and coordinates screening, consenting, and scheduling of test, exams, and/or non-medical/behavioral interventions and assessments involving study subjects. Coordinates, facilitates, and performs various study activities; manages all follow-up activities with subjects based on protocols.
• Records study data, samples, and/or results in various databases. Maintains databases for subjects and subject scheduling. Performs data validation checks and pursues resolutions to erroneous data. Produces various reports in response to requests from principal investigator (PI), sub-investigators, and/or other study stakeholders.
• Monitors study team compliance with protocol and standard operating procedures (SOPs). Submits all regulatory paperwork required. Communicates with PI and sub-investigators about concerns or recommended changes in study protocols, etc.
• Assists with developing various communications and strategies for advertising and recruitment, as well as in developing information materials for study participants.
• Stays up to date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings.
• Provides various other clinical research study or project support as needed (such as assisting with budget development, invoicing for adverse events, billing compliance and patient billing resolution).
• May provide guidance and/or support to less experience clinical research staff.