CLINICAL RESEARCH COORDINATOR - ONCOLOGY
About The Position
The Clinical Research Coordinator – Oncology ensures the integrity and quality of clinical trials and conducts them in accordance with applicable federal, state, and local regulations, IRB approvals, and program Standard Operating Procedures. The coordinator ensures each protocol is followed accurately and completely and assists study investigators in coordinating and facilitating study-patient activities. The role includes supporting participant recruitment and eligibility screening, conducting protocol-required tests and assessments, administering investigational medications when applicable, educating participants, documenting clinical data, and maintaining accurate and timely study records. The coordinator also supports regulatory compliance, research operations, and communication among research teams, participants, investigators, sponsors, monitors, and other parties.
Requirements
- 2–4 years of experience in medical practice; prior oncology and/or acute-care experience is preferred in the posting.
- 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.
- Adherence to all Toledo Clinic policies and procedures.
- Bachelor’s degree and/or equivalent experience.
Nice To Haves
- Experience conducting clinical research, including enrolling patients in research studies, implementing research protocols, and presenting findings.
- Knowledge of GCP.
- Prior experience in oncology and/or an acute-care setting.
Responsibilities
- Ensure compliance with each study protocol through thorough review and documentation at every subject study visit.
- Participate in recruiting and selecting study participants by interviewing them and documenting medical histories to assess eligibility.
- Interface with study participants to support eligibility determination and informed-consent requirements according to protocol.
- Perform required medical or research procedures, including vital signs, imaging studies, specimen collection and processing, and electrocardiograms.
- Administer investigational medications when applicable and assess patients during clinic visits for side effects; 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 to confirm 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 promptly in sponsor systems and the TCCC electronic medical record, databases, and Clinical Trial Management System (CTMS).
- Support the research operations team in maintaining regulatory documents in accordance with SOPs and applicable regulations.
- Communicate and collaborate on study requirements with internal and external research-team members, sponsors, monitors, investigators, and study patients.
- Help identify and prioritize systems and infrastructure needed to maintain research quality and compliance.
- Maintain cooperative relationships, address conflict constructively, identify problems, offer solutions, and participate in resolving them.
- Maintain confidentiality of information concerning patients, physicians, employees, and visitors, sharing patient and hospital information only with appropriate personnel.
- Perform 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 all Toledo Clinic policies and procedures.
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What This Job Offers
Job Type
Full-time
