Clinical Research Coordinator - Oncology

Toledo Clinic•Maumee, OH

About The Position

The Clinical Research Coordinator ensures the integrity and quality of oncology clinical trials and that they are conducted in accordance with federal, state, and local regulations, Institutional Review Board (IRB) approvals, program Standard Operating Procedures, and individual study protocols. The coordinator supports investigators by coordinating and facilitating study-patient activities and ensuring protocol completeness, accuracy, and compliance. The role involves participant recruitment and eligibility screening, study-visit documentation, performing research-related tests and assessments, administering investigational medications when applicable, and educating participants. The coordinator also maintains accurate source materials and study data, supports regulatory-document maintenance, and communicates study requirements to research-team members and external partners. The position requires adherence to patient confidentiality, safety practices, applicable laws and regulations, and organizational policies and values.

Requirements

  • 2–4 years of experience in medical practice; prior oncology and/or acute-care experience is preferred.
  • Proven knowledge of patient treatment and coordination of clinical care.
  • Attention to detail in collecting and analyzing data.
  • Strong verbal and written communication skills for interacting with patients and reporting research findings.
  • DOT/IATA training, to be obtained within 30 days of hire.
  • Certification in Human Subjects Protection and Good Clinical Practices, to be obtained within 30 days of hire.
  • Bachelor's degree and/or equivalent experience.
  • Adherence to all Toledo Clinic policies and procedures.

Nice To Haves

  • Prior experience in oncology and/or an acute-care setting.
  • Experience conducting clinical research, including enrolling patients in research studies, implementing research protocols, and presenting findings.
  • Knowledge of Good Clinical Practice (GCP).

Responsibilities

  • Review and document each subject study visit to ensure compliance with the study protocol.
  • Participate in recruitment and selection of study participants by interviewing them and documenting medical history to assess eligibility.
  • Interface with study participants to support eligibility determination and protocol-specific consent requirements.
  • Perform medically or research-required tests, including vital signs, imaging studies, specimen collection and processing, and electrocardiograms.
  • Administer investigational medications when applicable and assess patients for side effects during clinic visits; notify the Principal Investigator of findings or issues.
  • Educate study participants about medication dosage and administration and disease treatment.
  • Document medical data in patient charts to capture protocol requirements.
  • Review regulatory requirements and ensure appropriate methods, practices, and procedures are implemented for research activities.
  • Develop accurate source materials and ensure compliance.
  • Collect, document, enter, and report data accurately and on time in sponsor systems and the TCCC electronic medical record, databases, and Clinical Trial Management System (CTMS).
  • Support the clinical research operations team in maintaining regulatory documents in accordance with SOPs and applicable regulations.
  • Communicate and collaborate on study requirements with internal and external parties, including sponsors, monitors, investigators, research-team members, and study patients.
  • Work with the research operations team to identify and prioritize systems and infrastructure needed to maintain research quality and compliance.
  • Maintain cooperative working relationships, address conflict constructively, identify problems, offer solutions, and participate in resolution.
  • Maintain confidentiality of information concerning patients, physicians, employees, and visitors; discuss patient and hospital information only with appropriate personnel.
  • Perform job duties safely, protect personal and coworker safety, and promptly report preventable hazards and unsafe practices to management.
  • Demonstrate the organization's mission and core values and comply with laws and regulations concerning patient health, safety, and medical information.
  • Adhere to Toledo Clinic policies and procedures.
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