Oncology Clinical Research Specialist

2 weeks ago

Hilton Head Island, South Carolina, United States St. Josephs Candler Full time
  • Position Overview
    • The Oncology Clinical Research Coordinator (CRC) is a dedicated research expert collaborating with the clinical Principal Investigator (PI) on various research initiatives. The CRC is tasked with managing and organizing the daily operations of clinical trials related to Cancer Care Delivery Research (CCDR) and cancer control studies as directed by the Oncology Clinical Research department manager. The role may also extend to non-treatment and Quality of Life research projects as needed. The CRC ensures adherence to the study protocol, relevant regulations (such as FDA guidelines), and Good Clinical Practice (GCP) along with Institutional Review Board (IRB) standards. Candidates should possess experience in a healthcare environment and be knowledgeable about standard practices and procedures in clinical oncology research.
  • Educational Background
    • Bachelor's Degree - Preferred
  • Professional Experience
    • 2-3 Years of Oncology Experience - Preferred
    • 1 Year of Clinical Research Experience - Preferred
  • Licenses & Certifications
    • Certified Clinical Research Coordinator Certification (CCRC) - Preferred
    • Certification must be obtained within 2 years of employment
    • Basic Life Support (BLS) Certification - Required
  • Key Responsibilities
    • Oversee study activities for assigned protocols to guarantee compliance with study requirements as well as local, federal, state, and institutional regulations. Maintain comprehensive documentation and records 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 discussions with healthcare providers. Actively engage in patient recruitment by discussing potential candidates with investigators, approaching them in the office or via phone, asking pre-screening questions, reviewing the trial details, and conducting the informed consent process.
    • Coordinate and supervise participant visits and any necessary tests or imaging in accordance with the protocol. Ensure that visits, tests, and imaging are scheduled appropriately and completed within the required timeframes. Monitor patient adherence to medication and maintain drug accountability for assigned protocols.
    • Monitor participants as per 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 these immediately 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 the appropriate databases, and address data queries promptly.

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