- Under direct supervision of a physician is responsible for enlisting, maintaining, and assuring protocol compliance for all patients on clinical trials.
- Collaborates with physician 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.
- Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol.
- Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability.
- In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
- Responsible for accurate and timely data collection, documentation, entry, query resolution and reporting. Schedules and participates in monitoring and auditing activities.
- Maintains regulatory documents in accordance with SOPs and applicable regulations.
- Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research.
- Provides a safe environment for patients, families, and clinical staff at all time through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC.
- Interacts with the Clinical Trial Sponsors to recruit new clinical trials for the site. In collaboration with the Principal Investigator, conducts feasibility questionnaires and participates in site selection process.
- Maintain documentation of clinical trial visits and invoice for the completed site activities.
- Order and maintain inventory of all study specific supplies including recruitment materials and specific lab kits.
- Collect, process and ship all study defined lab kits to the Central Lab as directed by the sponsor.
- Bachelor's Degree plus 2 years of general or clinical research experience OR High School diploma/GED plus 7 years of general or 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 or professional certification within 6 months of exam eligibility.
- CRA II should demonstrate experience/proficiency in the following functional areas as relevant to oncology clinical trials: study planning/development, study coordination/management, Investigational Product accountability, regulatory documentation and data collection
- Two or more years of experience in clinical research or oncology preferred
- Must be proficient with Microsoft office applications (Outlook, Word and Excel)
- Must be detail oriented, organized, self-motivated, be able to work independently and on a team, and the ability to stay on task;
- Must have excellent communication, teamwork and problem solving skills;
- Must be professional, possess a high degree of self-motivation and have a strong work ethic.
- Must have the ability to adapt and take-on additional tasks as requested;
- Must be capable of recognizing, and have the willingness, to resolve errors and issues;
- Must possess a high degree of integrity and the ability to maintain the utmost confidentiality in all company matters.
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Clinical Research Study Coordinator Level II - Little Rock, United States - CARTI
Description
JOB SUMMARY:
The Clinical Research Study Coordinator executes and coordinates daily clinical research activities according to GCP and FDA/ICH guidelines; completes and organizes all IRB/Sponsor regulatory documents; ensures IRB approved protocols are implemented and followed; conducts study specific training on new or amended protocols; educates patients and their families about clinical trial treatments; identifies patients for study eligibility; executes and documents the informed consent process; monitors patient status and safety; coordinates patient visits according to protocol; collects, processes and ships lab samples; collects, organizes and reports research data and resolves queries; maintains investigational product inventory and oversees the dispensing of investigational product; invoices for study related activities; participates in monitoring visits with study sponsors and regulatory agencies, and reports regularly to the Principal Investigator and Director of Clinical Research.
This position is a
Safety Sensitive Position.
The essential functions, physical demands, and mental competencies of this job require the employee maintain the ability to work in a constant state of alertness in a safe manner.
JOB SPECIFIC DUTIES AND RESPONSIBILITIES:
Requirements
EDUCATION, CERTIFICATION, LICENSURE and
REGISTRATION:
EXPERIENCE, KNOWLEDGE, SKILLS and
ABILITIES:
