Clinical Research Coordinator (HS)- Neurological Surgery

About the role

Clinical Research Coordinator to coordinate and perform daily clinical research activities in accordance with approved protocols administered by the non-cancer College of Medicine (COM) Center for Clinical Research Management (CCRM) for the Department of Neurological Surgery Clinical Research Team.

Responsibilities

• Assesses patient records to identify patients who are eligible to participate in specified clinical research protocols.
• Recruits, interviews and enrolls patients.
• Obtains informed consent and ensures consent process is administered in compliance to regulatory and sponsor requirements.
• Educates patients and families of purpose, goals, and processes of clinical study.
• Schedules and follows through with patient care appointments, procedures, & other diagnostic testing in accordance with study protocol.
• Collects, processes & evaluates biological samples.
• Administers, evaluates and calculates standardized scoring of diagnostic, psychological or behavioral testing or questionnaires.
• Maintains monitoring of patients for adverse reactions to study treatment, procedure or medication and notifies appropriate clinical professionals.
• Documents unfavorable responses and notifies research sponsors & applicable regulatory agencies.
• Evaluates patients for compliance related to protocol.
• Collects, extracts, codes, and analyzes clinical research data.
• Generates reports and reviews to ensure validity of data.
• Supports activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations.
• Coordinates and prepares for external quality assurance and control reviews by IRB, federal or industry sponsors.
• Participates in developing new research protocols and contributes to establishing study goals to meet protocol requirements.

Requirements

• Minimum Education Required: Bachelor’s Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required.
• Required Experience: One year experience in a clinical research capacity required.

Preferred Skills

• Experience or knowledge in inpatient clinical research preferred.
• Knowledge of medical terminology desired.
• Clinical research certification from an accredited certifying agency desired.
• Computer skills required with experience using Microsoft Software applications desired.