Clinical Research Coordinator I

Location: Hematology Oncology of Indiana Pay Range: $19.66 - $34.59 Job Description Summary: Responsible for the performance of the research study under the medical supervision of the Principal Investigator. The Clinical Research Coordinator I (non‑RN) is responsible for the overall successful implementation and ongoing management of the research studies. The role involves managing an average of five clinical trials open to accrual annually and/or an active patient volume of 2‑10 annually. All duties are performed in accordance with regulatory requirements and organizational policies. Key Responsibilities Plan, design, and implement phase 4 observational/registry trials with entry‑level complexity. Coordinate care for patients on clinical research protocols per GCP, ICH/FDA guidelines. Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires. Identify inclusion/exclusion criteria and manage subject identification, prescreening, screening, and re‑screening. Explain and obtain informed consent, ensuring all essential elements are covered. Review diagnostic tests and related documentation required per protocol. Capture, assess, and determine causal relationship of adverse events; document under supervision. Ensure proper storage, dispensing, handling, and destruction of investigational products; handle compromised products as required. Maintain IRB/IEC credentials and ensure GCP, licenses remain current. Report safety‑related subject discontinuation and adverse events to sponsor and IRB/IEC. Collect, record, and report accurate data, verifying against patients’ medical records. Protect scientific integrity of data and safeguard patient rights and safety. Prepare documents for monitoring visits and implement monitoring follow‑up actions. Escalate protocol non‑compliance issues to the PI and research department leadership. Execute study budget elements, research billing compliance, and financial practices. Qualifications Education: High school education required; some college preferred. Experience: Prior research or related medical science experience. Core Capabilities: Critical Thinking – problem solving, analysis, decision‑making, planning, time management, organizational skills. Interpersonal Effectiveness – diplomacy, conflict management, delegation, diversity awareness. Communication Skills – clear oral, written, and presentation skills; active listening. Customer Service & Organizational Awareness – strong customer focus, collaborative culture, business acumen. Self‑Management – independent judgment, time priority, stress handling, self‑starter, remote work ability. Computer Skills: Proficiency in MS Office Word, Excel, PowerPoint, and Outlook. Experience with EMR, EDC, and CTMS preferred. Travel: 0% Work Schedule: Monday to Friday 8:00 AM – 5:00 PM #J-18808-Ljbffr