- 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.
- Bachelor's 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.
- Two or more years of experience in oncology research 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.
- 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.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- The employee regularly is required to stand, walk, sit, use hand to finger, handle or feel objects, tools, or controls; and reach with hands and arms.
- Specific vision abilities required by this job include close vision and the ability to adjust focus.
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Research Study Coordinator II - Little Rock, United States - CARTI, Inc.
Description
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:
SUPERVISORY RESPONSIBILITY: None
EDUCATION, CERTIFICATION, LICENSURE and REGISTRATION:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
The work environment described here are representative of those an employee encounters while performing the essential functions of this job.
This position involves potential exposure to infectious diseases. Colleagues are offered appropriate vaccinations and safety training.
SAFETY SENSITIVE
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.
