Clinical Research Coordinator

Position Title Clinical Research Coordinator (CRC) Reports To Clinical Research Director FLSA Status Non-Exempt Department Clinical Research Location Carolina Oncology Specialists Job Summary We are seeking a Clinical Research Coordinator (CRC) with a minimum of two (2) years of clinical research experience to support ongoing and upcoming oncology clinical trials at our research site. This role works closely with the Clinical Research team to ensure the ethical, regulatory, and operational conduct of oncology studies in accordance with ICH-GCP, protocol requirements, and institutional policies. The CRC is responsible for independently managing day-to-day study operations while collaborating with investigators, sponsors, monitors, and site staff. The ideal candidate is highly organized, detail-oriented, and experienced in oncology clinical trials. Essential Functions Coordinates and conducts oncology clinical trials from study start‑up through close‑out in accordance with protocol requirements. Performs study visits per protocol, including screening, treatment visits, follow‑ups, and long‑term survival tracking. Assists with patient recruitment, prescreening, and enrollment activities. Conducts informed consent discussions and ensures proper documentation in compliance with GCP and IRB standards. Ensures protocol adherence, including visit window compliance, dose scheduling accuracy, and study procedures. Maintains accurate source documentation and completes case report forms (CRFs/eCRFs) in a timely manner. Tracks oncology‑specific assessments including ECOG performance status, tumor measurements, and imaging (RECIST criteria). Coordinates chemotherapy, immunotherapy, and investigational product scheduling in collaboration with infusion staff. Monitors treatment‑related toxicities and assists with CTCAE‑based adverse event reporting. Coordinates biospecimen collection, processing, and shipment per protocol requirements. Prepares and maintains regulatory binders (paper and electronic formats). Assists with IRB submissions, amendments, continuing reviews, and safety reporting. Ensures readiness for sponsor monitoring visits, audits, and regulatory inspections. Reports adverse events (AEs), serious adverse events (SAEs), and protocol deviations within required timelines. Serves as a primary point of contact for study participants and manages subject scheduling and follow‑up care. Enters study data into EDC systems and resolves data queries in a timely manner. Supports monitoring visits, audits, and inspections while ensuring data integrity and patient safety. Collaborates with the Clinical Research Manager to meet study timelines, enrollment goals, and site objectives. Communicates effectively with investigators, sponsors, CROs, monitors, and internal site staff. Assists with study start‑up, close‑out, staff onboarding, and training activities as needed. Demonstrates strong work ethic, professionalism, and teamwork in supporting departmental goals. Knowledge, Skills & Abilities Strong knowledge of ICH‑GCP guidelines, clinical trial regulations, and informed consent processes. Familiarity with oncology‑specific criteria including CTCAE and RECIST. Experience with electronic data capture (EDC) systems and regulatory documentation. Excellent organizational, time‑management, and multitasking skills. Ability to manage multiple studies independently in a fast‑paced environment. Strong communication and interpersonal skills with the ability to collaborate across teams. Attention to detail and commitment to data accuracy and patient safety. Ability to analyze and resolve issues related to study conduct and compliance. Education & Experience Minimum of 2 years of experience as a Clinical Research Coordinator or similar role required. Bachelor’s degree in life sciences, nursing, healthcare, or a related field preferred. Previous oncology clinical research experience preferred. Experience with interventional clinical trials preferred. Certification (CCRC, CCRP, or equivalent) preferred but not required. Phlebotomy experience or willingness to be trained (if applicable). Physical Requirements Must be able to sit, stand, and walk for extended periods. Must be able to lift up to 25 pounds. May require occasional travel between clinic or research sites. Equal Opportunity Employer We are committed to equal opportunity for all applicants and do not discriminate on the basis of race, religion, color, national origin, or sexual orientation, and we consider all qualified applicants equally. #J-18808-Ljbffr