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University of Southern California Research Coordinator I - RADIOLOGY in Los Angeles, California

Research Coordinator I - RADIOLOGYApply Keck School of Medicine Los Angeles, California

The Keck School of Medicine Department of Radiology is seeking for a Research Coordinator to assist investigators or other staff with Radiology clinical trials in subject recruitment, data collection, study-related activities and follow-up of enrolled subjects.

Protocol Related

● Liaises with PI and department leadership to develop a clinical workflow and recruitment plan for the study

● Assists in the creation of eCRFs in the RedCap Database while consulting with the investigators

● Maintains a patient enrollment log to track study enrollment progress Leads patient recruitment by screening patients, determines patient eligibility, schedules necessary tests and procedures for the patients’ research appointments by coordinating with external providers as needed.

● Ensures consent process is performed and documented in compliance with FDA, GCP, IRB, HIPAA, SOPs, sponsor and institutional regulations and policies. Ensures that written informed consent is obtained using correct version of the stamped Informed Consent.

● Answers patient’s questions regarding study procedures, risks and toxicities. Provides ongoing education to study subjects about clinical trials and provides significant new information that may affect a subject’s willingness to participate in a study, when needed. Evaluates subject compliance and promotes compliance through education.

● Assists with sample collection, processing, and shipment for each study.

Protocol Compliance

● Schedules or ensures that required tests and procedures for follow-up are done.

● Conducts ongoing assessment of protocol deviations and violations. Ensures that study toxicities are recorded correctly and accurately. If Serious Adverse Events are experienced, follows FDA guidelines for prompt reporting within 24 hours.

● Assists with submission of SAEs and protocol deviations to IRB, sponsor and FDA per FDA guidelines for expedited reporting.

Data Management

● Assists with data collection for research studies following established data collection and management procedures.

● Collects, records, enters and prepares data for analysis in the study database. Collects pertinent information from study participants through interviews, administration of tests or surveys or questionnaires, medical records review, or other collection procedures. Maintains accurate, complete and timely research records, including source documents, consent forms, case report forms, protocol documents, and regulatory documents, as required by sponsor and institutional guidelines. Updates automated databases such as OnCore and CAFE to register patients, upload consents, record study visit procedures and study visit dates

● Assists in the preparation of site for monitor visit and external/internal audits. Provides timely response to queries from sponsor and/or auditors.

● Collaborates with pharmacist or materials management personnel to maintain accurate accountability of investigational products and specimens.

Other Study related duties:

● Participates in NCI, FDA and pharmaceutical audits and is knowledgeable of their regulations, especially concerning the reporting of Serious Adverse Events

● Provides study summary and research charts for review by the DSMC and QAC committee

● Participates in auditing of research charts for the departments’ QAC Committee

Bilingual: Spanish-speaking or Mandarin-speaking candidates preferred.

Minimum Education: Bachelor's degree, combined experience/education as substitute for minimum education Minimum Experience: 1 year relevant experience as a research coordinator or working in some capacity in clinical research Minimum Field of Expertise: Administrative or research experience. Working knowledge of MS Office applications. Knowledge of medical environment and terminology. Demonstrated effective communication and writing skills. Ability to multi-task and prioritize. Demonstrated ability to work as part of a team as well as independently. Preferred Expertise/Experience: Knowledge and understanding of federal, state, and institutional research regulations as well as Good Clinical Practices (GCP) and HIPPA regulations. Phlebotomy license highly preferred

REQ20125425 Posted Date: 01/24/2023 - Thru date - 2023-02-15