Clinical Research Coordinator
American Oncology Network
Summary
Responsible for the performance of the research study under the medical supervision of the Principal Investigator. The Clinical Research Coordinator I (non-RN) is responsible for the overall successful implementation and ongoing management of the research studies. Ability to perform basic tasks and exhibit the knowledge of key aspects of clinical research at an essential or foundational level.
Job description
Job Description Summary
Responsible for the performance of the research study under the medical supervision of the Principal Investigator. The Clinical Research Coordinator I (non-RN) is responsible for the overall successful implementation and ongoing management of the research studies. Ability to perform basic tasks and exhibit the knowledge of key aspects of clinical research at an essential or foundational level.
Primary responsibility includes study designs with entry-level complexity (phase 4, observational/registry trial design) and associated study procedures. Administratively and clinically manage an average of 5 clinical trials open to accrual annually and/or active (on study treatment) patient volume of 2-10 annually.
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.
- 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
- Knowledge of the required elements of an informed consent form and the essential elements of the informed consent process
- Review diagnostic tests and related documentation required per protocol
- Follow process for capturing, assessing, determining causal relationship of adverse events to the investigational product, investigator oversight, reporting and following up on adverse events
- Ensure proper storage, dispensing, handling and destruction processes for investigational products
- Follow process for handling investigational products that have been compromised
KPA 2 – Regulatory and Data Integrity
- Follow Institutional Review Board (IRB) / Independent Ethics Committee (IEC) review, approval and reporting requirements for the site; maintain site credentials and ensure updated GCP and 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
- Collect, record and report accurate data per FDA guidelines and review against the patient’s medical record for completeness and accuracy under direct supervision
- Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials
- 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
KPA 3 – Research Financial Practices: Budget/Contract execution and practices research billing compliance
- Identify elements of a study budget as it relates to execution of a protocol
Position Qualifications/Requirements
Education
- High school education required
- Some college is preferred
Previous Experience
- Prior research or related medical science experience
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; ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters
- Communication Skills: Good command of the English language; effective communication skills (oral, written, presentation), active listener, and effectively provides balanced feedback
- Customer Service & Organizational Awareness: Strong customer focus; ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships
- Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development; self-motivated and self-starter with ability to work independently with limited supervision
- 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
Computer Skills
- Proficiency in MS Office Word, Excel, PowerPoint, and Outlook 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
Travel: 0%. Standard Core Workdays/Hours: Monday to Friday 8:00 AM – 5:00 PM.
Requirements
- High school education required
- Some college is preferred
- Prior research or related medical science experience
- Critical thinking, problem solving, analysis, decision-making, planning, time management and organizational skills
- Detail oriented with ability to exercise independent judgment
- 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)
- Strong customer focus
- Self-motivated and self-starter with ability to work independently with limited supervision
- Ability to work effectively in a fast-paced, multi-site environment
- Proficiency in MS Office Word, Excel, PowerPoint, and Outlook required
- Prior experience with electronic medical records (EMR) preferred
- Prior experience with clinical trial data entry systems (EDC) preferred
- Prior Clinical Trial Management Systems (CTMS) preferred
Company overview
American Oncology Network (AON) is one of the nation's fastest-growing networks of community oncology practices, founded in 2018 with headquarters in Fort Myers, Florida. As a physician-led alliance, AON partners with independent oncology practices across the United States to ensure the long-term viability of community-based cancer care. The network represents over 290 providers practicing across 21 states, serving more than 400,000 patients annually through more than 110 clinic locations. AON's innovative model provides comprehensive support services including centralized administrative functions, revenue cycle management, IT infrastructure, and access to ancillary services such as clinical laboratories, pathology, and specialty pharmacy operations. The organization focuses on value-based care delivery, participating in programs like the Enhancing Oncology Model to improve patient outcomes while reducing costs. AON enables community oncologists to maintain practice autonomy while benefiting from economies of scale, advanced clinical resources, and practice management expertise. The network has demonstrated strong growth, reporting $2 billion in annual revenue and expanding access to cutting-edge treatments like bispecific T-cell engager therapies across its national footprint.