Clinical Trials Coordinator for Oncology

1 week ago

Hilton Head Island, South Carolina, United States St. Josephs Candler Full time
  • Position Overview
    • The Oncology Clinical Research Coordinator (CRC) plays a pivotal role in the execution of clinical trials under the guidance of the Principal Investigator (PI). This professional is tasked with the organization and management of daily activities related to Cancer Care Delivery Research (CCDR) and cancer control trials as directed by the Oncology Clinical Research department manager. The CRC may also support non-treatment and Quality of Life studies as necessary. The primary responsibility of the CRC is to ensure adherence to study protocols, regulatory standards (such as FDA regulations), Good Clinical Practice (GCP), and Institutional Review Board (IRB) requirements. Candidates should possess experience in a healthcare environment and have a solid understanding of the clinical oncology research landscape. Key responsibilities include: identifying potential study participants through medical chart reviews, facilitating the informed consent process, coordinating patient appointments to meet protocol specifications, recruiting and enrolling study subjects, and managing data collection and entry. Additionally, the CRC may be involved in evaluating clinical trial protocols for site feasibility. This role requires the ability to collaborate effectively within a team and work independently with minimal supervision. This position is located in Hilton Head, SC.
  • Educational Background
    • Bachelor's Degree - Preferred
  • Professional Experience
    • 2-3 Years of Experience in Oncology - Preferred
    • 1 Year of Experience in Clinical Research - Preferred
  • Certifications
    • Certified Clinical Research Coordinator (CCRC) - Preferred
    • Certification to be obtained within 2 years of employment
    • Basic Life Support (BLS) Certification - Required
  • Core Responsibilities
    • Oversee study activities for assigned protocols to ensure compliance with study requirements and regulatory policies at local, federal, state, and institutional levels. Maintain comprehensive documentation related to study activities, including case report forms, source documents, pharmacy drug binders, and regulatory paperwork.
    • Evaluate the eligibility of potential participants through various methods, including medical record reviews and consultations with physicians and Advanced Practice Providers. Actively engage in patient recruitment by discussing potential candidates with investigators, approaching individuals in the office or via phone, asking pre-screening questions, explaining the trial to patients, and conducting the informed consent process.
    • Coordinate and supervise participant visits and necessary tests/imaging as per the protocol. Ensure that visits, tests, and imaging are scheduled within the designated timeframe and completed at each required interval. Monitor patient adherence to medication and maintain accountability for assigned protocols.
    • Monitor participants in accordance with protocol requirements, ensuring that any modifications to study treatment are overseen by the investigator and/or CRC under the investigator's supervision. Track patients throughout the trial for any adverse reactions and communicate findings promptly to the investigator.
    • Document and report adverse events, ensuring thorough review and follow-up by the treating physician. Collaborate with the investigator to monitor patient care and treatment side effects while maintaining detailed documentation for reporting and source records.
    • Responsible for the collection, processing, preparation, and shipping of laboratory specimens.
    • Gather participant data, enter it into relevant databases, and address data queries promptly.


PI

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