Job Overview

Under the guidance and supervision of the Principal Investigator (PI), ensure the integrity and quality of clinical trials are maintained and conducted in accordance with federal, state, and local regulations, Institutional Review Board (IRB) approvals, and institutional policies and procedures.

Essential Functions

• Coordinate nursing and patient care as applicable to research studies.
• Actively participate in patient care and/or patient follow-up in association with research studies.
• Ensure compliance with each study’s protocol by providing thorough review and documentation at each subject study visit.
• Assist in coordinating relevant appointments or tests after consulting with the physician as needed for protocol compliance.
• Participate in recruitment and selection of study participants by obtaining informed consent, interviewing, and documenting medical history to determine compliance with eligibility requirements.
• Under supervision of the attending physician or study prinical investigator, may administer investigational medications and perform patient assessments during clinic visits to determine presence of side effects; notify Principal Investigator of findings/issues.
• Provide patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment.
• Monitor and report to physicians, nurses, and pharmacists, dosage modifications and treatment calculations per protocol for compliance.
• Communicate information concerning patient clinical status, needs, or significant changes to the principal investigator and appropriate health professionals.
• Implement procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources.
• Report data to sponsor and respond to queries.
• Document source data in patient chart to capture protocol requirements.
• May serve as a resource person or act as a consultant within area of clinical expertise.
• May provide direct and/or indirect supervision to exempt and non-exempt staff (i.e., hiring/firing, performance evaluations, disciplinary action, approve time off, etc.).
• Perform related duties based on departmental need. This job description can be changed at any time.

Required Education

• Associate's Degree.
• Graduation from an accredited school of nursing.

Required Trainings/Certifications

Current valid RN license to practice in the State of Ohio by date of hire.

Required Experience

Two (2) years of clinical nursing experience in a hospital, clinic or similar health care setting.

Additional Qualifications Considered

One (1) year clinical trial research experience is ideal.

Physical Requirements/Work Environment