Clinical Research Coordinator II-Peds

Clinical Research Coordinator II-Peds

Job no: 541314
Work type: Staff Full-Time
Location: Jacksonville Campus
Categories: Allied Health, Office/Administrative/Fiscal Support, Grant or Research Administration, Health Care Administration/Support
Department:  - JX-PEDIATRICS-JACKSONVILLE

Clinical Research Coordinator II-Peds

Responsible for advanced-level coordination and implementation of assigned clinical research studies conducted through UF CARES, including HIV-related and other infectious disease research involving pediatric, adolescent, and adult participants. Independently coordinates assigned treatment, observational, and data/chart-based research studies in accordance with study protocols, institutional policies, Good Clinical Practice (GCP), and

applicable federal and regulatory requirements.

Coordinates research activities throughout the study lifecycle, including participant identification, recruitment and retention; informed consent and assent; study visits and

procedures; collection and management of research data; specimen collection and processing; adverse event and protocol deviation reporting; regulatory compliance; and communication with investigators, sponsors, study teams, and other stakeholders.

Identifies, recruits, and screens potential research participants according to protocol specific eligibility criteria. Coordinates and conducts the informed consent and assent process using current IRB-approved documents and ensures appropriate documentation in the research record and Epic, as applicable. Maintains ongoing

communication with participants and families to support study participation, retention,adherence to protocol requirements, and continuity of care.

Coordinates assigned clinical research protocols from study activation through participant follow-up and study closeout activities, as applicable. Plans and coordinates study visits, assessments, procedures, medication dispensing, laboratory testing, and other protocol-required activities. Develops and maintains protocol specific

worksheets, source documents, tracking tools, and other materials necessary for effective study implementation. Cross-trains on additional studies and provides coverage for other research coordinators as assigned.

Collects, reviews, enters, and maintains clinical research data obtained from medical records, participant interviews, questionnaires, laboratory results, and other approved sources. Completes and submits Case Report Forms (CRFs) and other study documentation accurately and within required timelines. Reviews data for accuracy, completeness, and consistency and promptly resolves data queries, logic checks, errors, and delinquencies. Participates in research quality assurance activities and supports monitoring, auditing, and data validation activities.

Maintains knowledge of and compliance with applicable research regulations, institutional policies, IRB requirements, FDA requirements, Good Clinical Practice, sponsor requirements, and protocol-specific procedures. Identifies, documents, and communicates protocol deviations, adverse events, serious adverse events, toxicities, abnormal laboratory findings, and other reportable events according to applicable

requirements and established timelines. Completes laboratory toxicity grading using the DAIDS toxicity table or other protocol-specific grading criteria when applicable.

Performs protocol-required phlebotomy for pediatric and/or adult research participants within demonstrated competency and scope of responsibility. Processes, prepares, labels, stores, tracks, and ships research specimens according to protocol, laboratory, and regulatory requirements. Performs centrifuging and aliquoting and assists with research specimen storage and freezer monitoring/maintenance. Ensures required study laboratory tests and diagnostic procedures are completed, reviewed, and appropriately documented.

Communicates and collaborates with investigators, healthcare providers, research participants and families, research pharmacists, protocol teams, sponsors, monitors, IRB personnel, laboratories, and UF CARES staff regarding study activities and participant needs. Communicates relevant clinical and research information, including signs and symptoms, toxicities, abnormal…