[Hiring] Clinical Research Coordinator III @American Oncology Network

Role Description

Responsible for the performance of the research study under the medical supervision of the Principal Investigator. Clinical Research Coordinator III (RN) performs tasks independently, consistently and accurately, and demonstrates a moderate level of expertise in all skills and abilities resulting in high-quality work. Responsibilities include complex types of study designs (phase 1-3 interventional trial design) and associated study procedures. Demonstrates working knowledge of all facets of the role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned, in accordance with regulatory requirements and organizational policies and procedures.

Primary Key Performance Areas

• KPA 1 – Protocol Comprehension and Implementation:
  • Coordination of care for patients on clinical research protocols in accordance with GCP, ICH/FDA guidelines and requirements.
  • Demonstrate understanding of protocol elements/requirements and ability to execute study procedures.
  • Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires.
  • Assess subjects on the basis of inclusion/exclusion criteria and evaluate/document subject eligibility independently.
  • Review draft informed consent documents in compliance with regulatory requirements and GCPs.
  • Conduct informed consent discussions in compliance with SOPs.
  • Review and interpret diagnostic test results and related documentation required per protocol.
  • Follow process for capturing, assessing, determining causal relationship of adverse events to the investigational product.
  • Recognize, report, and follow up on all types of adverse events.
  • Dispense study medication in a professional and accountable manner following protocol requirements.
  • Maintain accurate records of the receipt, inventory, distribution, and destruction of study-related materials/investigational products.
  • Ensure investigational drug is received, stored, and documented, and that excess materials are returned to the sponsor according to guidelines.
• KPA 2 – Regulatory and Data Integrity:
  • Understanding of the IRB/IEC review, key elements of review considerations, approval and reporting requirements for the site.
  • Complete all IRB/IEC-related documents over the course of a clinical study.
  • Maintain site credentials and ensure updated GCP, licenses remain on file.
  • Comply with reporting of safety-related subject discontinuation and safety concerns (AE, SAE or AE of Interest) to the sponsor and IRB/IEC.
  • Autonomously collect, record, and report accurate data per FDA guidelines.
  • Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials.
  • Manage a monitoring visit including appropriate preparations, support, documentation, and follow up.
  • Implement a CAPA assessment and follow CAPA-related issues through to resolution.
  • Escalate issues of protocol non-compliance to study PI and research department leadership.
• KPA 3 – Research Financial Practices:
  • Assess a protocol and study plan to develop a study budget.
  • Understand the payment terms of the study budget and track items that need to be invoiced for a clinical study.

Qualifications

• Bachelors or Associates degree in Nursing is required.
• Unencumbered RN License in state of employment or multi-state license.
• Valid state Driver’s License for travel to satellite offices and offsite meetings.
• 2-5 years nursing experience required, oncology preferred.

Core Capabilities

• Analysis & Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management, and organizational skills. Must be detail-oriented with the ability to exercise independent judgment.
• Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness.
• Communication Skills: Good command of the English language. Effective communication skills (oral, written, presentation), active listener, and provides balanced feedback.
• Customer Service & Organizational Awareness: Strong customer focus and ability to build an engaging culture of quality, performance effectiveness, and operational excellence.
• Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development.
• Computer Skills: Proficiency in MS Office Word, Excel, Power Point, and Outlook required.

Travel

0%

Standard Core Workdays/Hours

Monday to Friday 8:00 AM – 5:00 PM