American Oncology Network · 1 week ago
Clinical Research Coordinator II
Kansas City, MO
Full-time
Onsite
Entry, Mid Level
$25.50/hr - $44.84/hr
2+ years expAmerican Oncology Network is focused on providing high-quality cancer care, and they are seeking a Clinical Research Coordinator II to manage and oversee clinical trials. The role involves coordinating care for patients on clinical research protocols, ensuring compliance with regulatory requirements, and maintaining data integrity throughout the research process.
Health CareHealth DiagnosticsMedicalOncology
Responsibilities
Coordinate care for patients on clinical research protocols in accordance with GCP, ICH/FDA guidelines and requirements
Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires
Assess subjects on the basis of inclusion/exclusion criteria and demonstrate the ability to evaluate and document subject eligibility independently
Reviews draft informed consent documents in compliance with regulatory requirements and GCPs
Conduct an informed consent discussion in compliance with SOPs
Review and interpret diagnostic test results and related documentation required per protocol
Follows process for capturing, assessing, determining causal relationship of adverse events to the investigational product, investigator oversight, reporting and following up on adverse events
Maintain accurate records of the receipt, inventory, distribution and destruction of study-related materials / investigational products and research specimens
Ensure that the investigational drug is received, stored, and documented, and that excess materials are returned to the sponsor according to sponsor guidelines and in accordance with Code of Federal Regulations
Assesses and manages investigational products that have been compromised
Complete all IRB/IEC-related documents over the course of a clinical study
Maintains site credentials and ensures 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 and demonstrate per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy
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
Maintain proper (accurate and timely) communication with the monitor and follow up on all monitor requests
Implement a CAPA assessment and follow CAPA related issues through to resolution
Escalates issues of protocol non-compliance to study PI and research department leadership
Assess a protocol and study plan to develop a study budget
Qualification
Required
High school education required
Some college required
2-5 years prior oncology research/related medical science experience
Proficiency in MS Office Word, Excel, Power Point, and Outlook required
Demonstrate an understanding of protocol elements / requirements and demonstrate the ability to execute study procedures
Demonstrate the ability to anticipate and mitigate the potential for protocol non-compliance
Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires
Assess subjects on the basis of inclusion/exclusion criteria and demonstrate the ability to evaluate and document subject eligibility independently
Reviews draft informed consent documents in compliance with regulatory requirements and GCPs
Conduct an informed consent discussion in compliance with SOPs
Review and interpret diagnostic test results and related documentation required per protocol
Follows process for capturing, assessing, determining causal relationship of adverse events to the investigational product, investigator oversight, reporting and following up on adverse events
Maintain accurate records of the receipt, inventory, distribution and destruction of study-related materials / investigational products and research specimens
Ensure that the investigational drug is received, stored, and documented, and that excess materials are returned to the sponsor according to sponsor guidelines and in accordance with Code of Federal Regulations
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
Maintains site credentials and ensures 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 and demonstrate per FDA guidelines, and review them against the patient's medical record for completeness and accuracy
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
Maintain proper (accurate and timely) communication with the monitor and follow up on all monitor requests
Implement a CAPA assessment and follow CAPA related issues through to resolution
Escalates issues of protocol non-compliance to study PI and research department leadership
Assess a protocol and study plan to develop a study budget
Understanding of the payment terms of the study budget and the items that need to be invoiced for a clinical study
Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills
Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness
Good command of the English language
Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback
Strong customer focus
Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices
Self-motivated and self-starter with ability work independently with limited supervision
Ability to work remotely effectively as required
Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites
Preferred
Bachelor's degree preferred and/or Licensed Practical Nurse required
Second language is an asset but not required
Prior experience with electronic medical records (EMR) is preferred
Prior experience with clinical trial data entry systems (EDC) preferred
Prior Clinical Trial Management Systems (CTMS) preferred
Company
American Oncology Network
American Oncology Network provides support and ancillary services for oncologist and cancer patients. It is a sub-organization of Cancer & Blood Specialists of Arizona.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2023-09-20IPO
Leadership Team
Todd Schonherz
Chief Executive Officer and Board Member
David Afshar
Chief Financial and Operating Officer
Recent News
2026-01-06
2026-01-06
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