American Oncology Network
Clinical Research Coordinator (Non-RN)
American Oncology Network, Honolulu, Hawaii, United States, 96814
Clinical Research Coordinator (Non‑RN) – American Oncology Network
Location: Hawaii Cancer Care.
Pay Range: $22.93 – $40.31 per hour.
Job Description Summary Responsible for the performance of research studies under the medical supervision of the Principal Investigator. The Clinical Research Coordinator I (non‑RN) oversees successful implementation and ongoing management of clinical trials, performing basic tasks and demonstrating knowledge of key aspects of clinical research.
Primary Responsibilities
Coordinate study designs of entry‑level complexity and manage an average of 5 clinical trials open to accrual annually.
Administer study procedures, patient accrual (2–10 patients annually), and regulatory requirements.
Perform protocol feasibility assessments, site visits, and subject screening processes.
Document adverse events, investigational product handling, and safety reporting.
Maintain investigational product storage, dispensing, and destruction protocols.
Prepare and review monitoring visit documentation.
Escalate protocol non‑compliance issues to PI and research leadership.
Key Performance Areas (KPAs)
KPA 1 – Protocol Comprehension and Implementation
Identify key protocol elements and perform study tasks under supervision.
Conduct protocol feasibility assessments and complete questionnaires.
Explain inclusion/exclusion criteria and subject identification processes.
Handle informed consent processes and review related documentation.
Capture, assess, and determine adverse events and manage reporting.
Ensure proper handling and storage of investigational products.
Follow procedures for compromised investigational products.
KPA 2 – Regulatory and Data Integrity
Follow IRB/IEC review, approval, and reporting requirements.
Maintain site credentials and ensure GCP compliance.
Report safety‑related subjects discontinuation, AEs, and SAEs.
Collect and verify accurate data per FDA guidelines.
Prepare documents for monitoring visits and review monitoring reports.
Escalate protocol non‑compliance issues.
KPA 3 – Research Financial Practices
Identify elements of a study budget related to protocol execution.
Position Qualifications / Requirements
High school education required; some college preferred.
Prior research or related medical science experience.
Core Capabilities
Analysis & Critical Thinking – strong problem solving, decision‑making, planning, and organizational skills.
Interpersonal Effectiveness – emotional intelligence, diplomacy, conflict management.
Communication Skills – effective verbal and written communication.
Customer Service & Organizational Awareness – strong customer focus and collaboration.
Self‑Management – manages own time and work independently, thrives in fast‑paced environments.
Computer Skills
Proficient in MS Office (Word, Excel, PowerPoint, Outlook).
Prior experience with EMR systems preferred.
Prior experience with EDC and CTMS preferred.
Travel 0 %
Standard Core Workdays / Hours
Monday to Friday, 8:00 AM – 5:00 PM.
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Pay Range: $22.93 – $40.31 per hour.
Job Description Summary Responsible for the performance of research studies under the medical supervision of the Principal Investigator. The Clinical Research Coordinator I (non‑RN) oversees successful implementation and ongoing management of clinical trials, performing basic tasks and demonstrating knowledge of key aspects of clinical research.
Primary Responsibilities
Coordinate study designs of entry‑level complexity and manage an average of 5 clinical trials open to accrual annually.
Administer study procedures, patient accrual (2–10 patients annually), and regulatory requirements.
Perform protocol feasibility assessments, site visits, and subject screening processes.
Document adverse events, investigational product handling, and safety reporting.
Maintain investigational product storage, dispensing, and destruction protocols.
Prepare and review monitoring visit documentation.
Escalate protocol non‑compliance issues to PI and research leadership.
Key Performance Areas (KPAs)
KPA 1 – Protocol Comprehension and Implementation
Identify key protocol elements and perform study tasks under supervision.
Conduct protocol feasibility assessments and complete questionnaires.
Explain inclusion/exclusion criteria and subject identification processes.
Handle informed consent processes and review related documentation.
Capture, assess, and determine adverse events and manage reporting.
Ensure proper handling and storage of investigational products.
Follow procedures for compromised investigational products.
KPA 2 – Regulatory and Data Integrity
Follow IRB/IEC review, approval, and reporting requirements.
Maintain site credentials and ensure GCP compliance.
Report safety‑related subjects discontinuation, AEs, and SAEs.
Collect and verify accurate data per FDA guidelines.
Prepare documents for monitoring visits and review monitoring reports.
Escalate protocol non‑compliance issues.
KPA 3 – Research Financial Practices
Identify elements of a study budget related to protocol execution.
Position Qualifications / Requirements
High school education required; some college preferred.
Prior research or related medical science experience.
Core Capabilities
Analysis & Critical Thinking – strong problem solving, decision‑making, planning, and organizational skills.
Interpersonal Effectiveness – emotional intelligence, diplomacy, conflict management.
Communication Skills – effective verbal and written communication.
Customer Service & Organizational Awareness – strong customer focus and collaboration.
Self‑Management – manages own time and work independently, thrives in fast‑paced environments.
Computer Skills
Proficient in MS Office (Word, Excel, PowerPoint, Outlook).
Prior experience with EMR systems preferred.
Prior experience with EDC and CTMS preferred.
Travel 0 %
Standard Core Workdays / Hours
Monday to Friday, 8:00 AM – 5:00 PM.
#AONA
#J-18808-Ljbffr