Job Overview
Employment Type
Full-time
Compensation
Hourly
Range $23.25 - $31.00
Work Schedule
Standard Hours
Benefits
Sign-On Bonus
Health Insurance
Paid Time Off
Retirement Plan
Continuing education support
Professional development opportunities
Flexible work schedule
Job Description
The hiring establishment is a leading cancer research and treatment center known for its commitment to advancing oncology clinical trials and providing comprehensive care to patients. This organization emphasizes adherence to the highest standards of clinical research practices by following Good Clinical Practice (GCP) guidelines and FDA/ICH regulations, ensuring both patient safety and data integrity. As a specialized cancer research facility, the center conducts a variety of clinical trials designed to evaluate new treatments and therapies for cancer patients. The center is dedicated to maintaining compliance with regulatory requirements and supporting the continuous professional development of its research staff.
The Clinical Research Study Coordinator role is integral to the successful execution and management of clinical research studies within this environment. The coordinator is responsible for executing and coordinating daily clinical research activities in accordance with GCP and other regulatory guidelines. This role involves completing International Regulatory Board (IRB) and sponsor regulatory documents, ensuring that all study protocols approved by the IRB are thoroughly implemented and adhered to. The coordinator will receive ongoing study-specific training for new or amended protocols and plays a key role in educating patients and their families about clinical trial treatments, their eligibility, and the consent process.
This position requires attentiveness in monitoring patient status, managing adverse event documentation, coordinating patient visits as per protocols, and handling laboratory sample collection following International Air Transportation Association (IATA) guidelines. Additionally, the coordinator is responsible for maintaining investigational product inventory, dispensing support through the research pharmacy, and supporting billing compliance for study-related activities. They also prepare study materials for monitoring visits and regulatory inspections, report regularly to the Principal Investigator and research leadership, and assist in maintaining study files and documentation.
A $5,000 sign-on bonus is available for eligible new hires, paid partly at the first paycheck and the remainder after one year of continuous employment. This opportunity offers a dynamic, rewarding work environment where rigorous clinical research efforts contribute directly to advancing cancer treatment options. The position requires a detail-oriented, proactive, and highly professional candidate who is passionate about clinical research and patient safety. Travel to satellite locations is a job requirement, emphasizing flexibility and teamwork across various clinical settings. Working at this center means being part of a dedicated team focused on improving outcomes for cancer patients through innovative research and high-quality clinical care.
The Clinical Research Study Coordinator role is integral to the successful execution and management of clinical research studies within this environment. The coordinator is responsible for executing and coordinating daily clinical research activities in accordance with GCP and other regulatory guidelines. This role involves completing International Regulatory Board (IRB) and sponsor regulatory documents, ensuring that all study protocols approved by the IRB are thoroughly implemented and adhered to. The coordinator will receive ongoing study-specific training for new or amended protocols and plays a key role in educating patients and their families about clinical trial treatments, their eligibility, and the consent process.
This position requires attentiveness in monitoring patient status, managing adverse event documentation, coordinating patient visits as per protocols, and handling laboratory sample collection following International Air Transportation Association (IATA) guidelines. Additionally, the coordinator is responsible for maintaining investigational product inventory, dispensing support through the research pharmacy, and supporting billing compliance for study-related activities. They also prepare study materials for monitoring visits and regulatory inspections, report regularly to the Principal Investigator and research leadership, and assist in maintaining study files and documentation.
A $5,000 sign-on bonus is available for eligible new hires, paid partly at the first paycheck and the remainder after one year of continuous employment. This opportunity offers a dynamic, rewarding work environment where rigorous clinical research efforts contribute directly to advancing cancer treatment options. The position requires a detail-oriented, proactive, and highly professional candidate who is passionate about clinical research and patient safety. Travel to satellite locations is a job requirement, emphasizing flexibility and teamwork across various clinical settings. Working at this center means being part of a dedicated team focused on improving outcomes for cancer patients through innovative research and high-quality clinical care.
Job Requirements
- Bachelor's degree plus 2 years clinical research experience or High School diploma/GED plus 7 years clinical research experience
- must obtain GCP certification within first 30 days of hire
- must obtain IATA certification within first 30 days of hire
- CCRP or CCRC certification within 6 months of exam eligibility
- two or more years of oncology research experience preferred
- proficiency with Microsoft Office applications
- ability to work independently and on a team
- excellent communication skills
- high degree of self-motivation and professionalism
- ability to maintain confidentiality
- willingness to travel to CARTI Cancer Center locations
- ability to pass physical demands including sitting, walking, standing, use of hands, and close vision
- must work safely in potential exposure to infectious diseases
Job Qualifications
- 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 within first 30 days of hire
- must obtain IATA certification within 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
- proficient with Microsoft Office applications including Outlook, Word, and Excel
- detail oriented, organized, self-motivated, able to work independently and on a team
- excellent communication, teamwork, and problem-solving skills
- professional with a high degree of self-motivation and strong work ethic
- adaptable and willing to take on additional tasks
- capable of recognizing and resolving errors and issues
- possess high integrity and ability to maintain confidentiality
- experience or proficiency in oncology clinical trial functions such as study planning, coordination, investigational product accountability, regulatory documentation, and data collection
Job Duties
- 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 SOP, principles of GCP and applicable federal, state, and local regulations
- communicates research goals and protocol structured treatment plan to potential subjects during informed consent discussion
- conducts ongoing informed consent process and documents appropriately
- addresses protocol specific questions raised by subjects with support from treating investigator
- educates 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
- reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance and response to study drug
- submits accurate and timely data collection, documentation, and query resolution
- collaborates with study monitors to ensure protocol compliance and patient safety
- prepares and supports research department during inspections or audits
- supports and assists with maintenance of Investigator Site File as needed
- participates in required training and continuing education programs
- provides a safe environment for patients, families, and clinical staff
- supports billing compliance for study related activities
- orders and maintains inventory of study supplies including recruitment materials and central lab kits
- collects, processes, and ships bio-specimens to Central Lab per protocol and IATA guidelines
- performs other assigned duties
Job Criteria
Experience
Mid Level (3-7 years)
Job Location
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