Clinical Research Coordinator (Non-RN)

American Oncology Network

79d • $22 - $40

About The Position

The Clinical Research Coordinator I (non-RN) is responsible for the overall successful implementation and ongoing management of research studies under the medical supervision of the Principal Investigator. This role involves performing basic tasks and exhibiting knowledge of key aspects of clinical research at an essential or foundational level. The primary responsibility includes study designs with entry-level complexity (phase 4, observational/registry trial design) and associated study procedures. The coordinator will administratively and clinically manage an average of 5 clinical trials open to accrual annually and/or an active patient volume of 2-10 annually. The position requires a working knowledge of all facets of the role, relevant regulations, and organizational and departmental policies and procedures. Other duties and projects may be assigned as necessary, and all duties must be performed in accordance with regulatory requirements and organizational policies and procedures.

Requirements

• High school education required.
• Some college is preferred.
• Previous research or related medical science experience.

Responsibilities

• Coordination of care for patients on clinical research protocols in accordance with GCP, ICH/FDA guidelines and requirements.
• Identify and explain key protocol elements and perform study tasks under direct supervision.
• Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires.
• Identify and explain inclusion/exclusion criteria and the process of subject identification, prescreening, screening, and re-screening.
• Review diagnostic tests and related documentation required per protocol.
• Follow processes for capturing, assessing, determining causal relationships of adverse events to the investigational product, and reporting and following up on adverse events.
• Document different types of adverse events under direct supervision.
• Ensure proper storage, dispensing, handling, and destruction processes for investigational products.
• Follow processes for handling investigational products that have been compromised.
• Maintain site credentials and ensure updated GCP, licenses remain on file.
• Comply with reporting of safety-related subject discontinuation and safety concerns to the sponsor and IRB/IEC.
• Collect, record, and report accurate data and demonstrate per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy under direct supervision.
• Prepare documents for monitoring visits under direct supervision.
• Review visit monitoring follow-up reports/letters and perform requested activities.
• Escalate issues of protocol non-compliance to study PI and research department leadership.
• Identify elements of a study budget as it relates to execution of a protocol.

Benefits

• Comprehensive health insurance with a robust provider network.
• 401k with a 100% match and investment options.
• Generous Paid Time Off (PTO) program.
• Professional development programs and tuition assistance.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 1,001-5,000 employees