ASST. CLINICAL RESEARCH COORDINATOR - HYBRIDAt — UC Irvine Chao Family Comprehensive Cancer Center

Under supervision of the Clinical Research Manager of the Clinical Trials Unit, the Assistant Clinical Research Coordinator supports the clinical research efforts of the Cancer Center by providing comprehensive coordination and data management of multiple Phase II-IV cancer-related protocols according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures.

The incumbent is responsible for supporting and coordinating all aspects of the cancer-related trials (Phase II-IV) for protocol specific requirements, research procedures, research chart preparation, data collection, and record keeping. Attends clinic to assist the Principal Investigator (PI) with recruitment, screening, consenting, administering questionnaires, answer research patient questions, schedule appointments, etc.

Serve as the liaison to sponsors, governing agencies and facilitate transmission of verbal and written communication to national cooperative oncology groups, pharmaceutical companies and other research entities as needed. The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, including attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.

In addition, this individual must accurately maintain clinical trial information in the clinical trial management system (OnCore) adhere to institutional policies and external Cancer Center Support Grant guidelines for reporting to the National Cancer Institute (NCI).

Tasks:

-Identify potential participants through medical records, referrals, or outreach
-Pre-screen patients against inclusion/exclusion criteria
-Conduct informed consent discussions and obtain consent/assent
-Schedule screening visits and assessments
-Schedule and coordinate participant visits per protocol
-Conduct study visits and procedures as delegated (e.g., vitals, ECGs, questionnaires)
-Collect, process, and ship biological samples (blood, urine, tissue)
-Administer investigational product per protocol (if applicable and trained)
-Monitor participant safety and well-being throughout the study
-Accurately collect source data from medical records and participant reports
-Enter data into electronic data capture (EDC) systems
-Resolve data queries in a timely manner
-Maintain accurate and complete source documentation
-Ensure protocol deviations are documented and reported
-Identify, document, and report adverse events and serious adverse events
-Coordinate safety reporting to sponsors, IRBs, and regulatory authorities
-Assist investigators with safety narratives and follow-up
-Serve as the primary site contact for sponsors, CROs, and monitors
-Prepare for and support monitoring visits, audits, and inspections
-Respond to monitor findings and follow-up action items

Training:

ACRCs have weekly 1-1 meetings with the Clinical Trial Manager (CRM) to discuss work tasks, research procedure adherence, work goals, and professional goals. There is usually an onboarding training at the beginning, however Stephany has been working with us for some time and is no longer in the onboarding training. However, as this facility and role go through regular challenges, there is always something new to learn and implement. They work directly with patients, so there is always an emphasis of nuanced tasks in this role.

Learning Outcome:

- Coordinate research, properly evaluate information, and prepare concise, well organized reports, summaries, and correspondence among the study team and sponsors
- Prioritize assignments and achieve high productivity/quality with short time frames, under rigid deadlines, and /or in environments with frequent workload changes and competing demands
- Able to think critically, compile data from various sources, analyze data, and prepare reports.
- complete tasks such as facilitate research trial consents with patients, read and digest research protocols to ensure the proper conduct of research assessments and visits, communicate effectively between multidisciplinary teams.