Research Study Coordinator II

Research Study Coordinator II (Project Management)

The Clinical Research Study Coordinator executes and coordinates daily clinical research activities according to Good Clinical Practice (GCP) and FDA/ICH guidelines; completes International Regulatory Board (IRB)/Sponsor regulatory documents as needed; ensures IRB approved protocols are implemented and followed; completes study specific training on new or amended protocols as needed; educates patients and their families about clinical trial treatments; identifies patients for study eligibility;

executes and documents the informed consent process; reviews patient status and documents adverse events; coordinates patient visits according to protocol; collects, processes and ships lab samples per International Air Transportation Association (IATA) guidelines; collects, organizes and reports research data and resolves queries; maintains investigational product inventory and supports the dispensing of investigational product through the Research pharmacy; supports billing compliance for study related activities;

prepares study materials for monitoring visits with study sponsors and regulatory agencies, and reports regularly to the Principal Investigator and Research Leadership.

JOB SPECIFIC

DUTIES AND RESPONSIBILITIES:

• Enlists, maintains, and assures protocol compliance for patients on clinical trials.
• Prescreens for potential research subjects.
• Collaborates with investigator in determining eligibility of patients for clinical trials.
• Ensures site research quality by practicing in compliance with Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations.
• Communicates research goals and protocol structured treatment plan to potential subjects during informed consent discussion.
• Conducts the ongoing informed consent process and documents appropriately according to standard operating procedures and federal guidelines.
• Address protocol specific questions raised by the subjects with support from the treating investigator.
• Educate subjects on all study related procedures such as: ePROs, patient drug diaries and investigational product.
• Performs randomization and enrollment per protocol guidelines.
• Coordinates patient care in compliance with protocol requirements.
• Maintains investigational product accountability, receipt, dispensation and destruction.
• In collaboration with the Investigator, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
• Submits accurate and timely data collection, documentation, entry, query resolution and reporting.
• Collaborates with the study monitors between and during monitor visits to ensure protocol compliance and patient safety.
• Prepares and supports research department during inspections or audits.
• Supports and assists with the maintenance of the Investigator Site File (ISF) as needed.
• Participates in required training and continuing education programs.
• Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC.
• Supports billing compliance for study related activities by maintaining accurate enrollment logs and entering patient visit data into site CTMS in a timely manner.
• Orders and maintains inventory of all study specific supplies including recruitment materials and central lab kits.
• Collects, processes and ships bio-specimens to the Central Lab per protocol and following IATA guidelines.
• Other duties as assigned.

OTHER

JOB REQUIREMENTS:

Travel to CARTI Cancer Center and Clinic locations outside of Little Rock as required.

SUPERVISORY RESPONSIBILITY: None

EDUCATION, CERTIFICATION, LICENSURE and REGISTRATION: Bachelors Degree plus 2 years of clinical research experience OR High School diploma/GED plus 7 years of clinical research experience. Must obtain GCP certificate in first 30 days of hire. Must obtain IATA certification in first 30 days of hire. CCRP or CCRC certification within 6 months of exam eligibility.

EXPERIEN…