Clinical Research Coordinator II-Peds ID

University of Florida; Jacksonville (FL); On-site; USD 59,000 - 67,000; Full time

Job summary

University of Florida seeks a Clinical Research Coordinator II for the Pediatric ID program. The role coordinates advanced pilot and full studies, ensuring protocols are followed per GCP, IRB, and sponsor requirements.

Tasks include recruitment, consent, data collection, safety reporting, and cross-team communication. The position supports pediatric, adolescent, and adult participants, with duties spanning study visits, sample handling, and regulatory documentation.

Qualifications

• Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.

Responsibilities

• Coordinates clinical research protocols from study activation through participant follow-up and study closeout.
• Plans and coordinates study visits, assessments, procedures, medication dispensing, laboratory testing, and other protocol-required activities.
• Develops protocol-specific worksheets, source documents, tracking tools, and other materials 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 from medical records, interviews, questionnaires, lab results, and other sources.
• Completes Case Report Forms and other study documentation accurately and within required timelines; resolves data queries and errors.
• Maintains knowledge of applicable regulations and ensures regulatory compliance and safety reporting.
• Performs protocol-required phlebotomy and manages specimen processing and storage.

Education

Bachelor's degree in an appropriate area

Job description

Classification Title

Clinical Research Coordinator II-Peds ID

Classification Minimum Requirements

Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.

Job Description

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.

Participant Recruitment, Screening, Enrollment & Retention

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.

Study Coordination & Protocol Implementation

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.

Research Data Collection, Documentation & Quality Assurance

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.

Regulatory Compliance & Participant Safety

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.

Clinical Research Procedures & Specimen Management

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.

Research Team, Investigator & Sponsor Communication

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 results, protocol deviations, adverse events, and study requirements, to appropriate members of the research and clinical teams. Serves as a knowledgeable resource regarding assigned protocols and research procedures.

Research Education & Team Support

Provides protocol-specific education and in-services to UF CARES staff and other participating personnel as appropriate. Maintains current knowledge of assigned clinical research areas through protocol training, required continuing education, investigator meetings, study activities, and review of relevant research literature.

Serves as a cross‑trained resource and backup for other clinical research staff and assists with onboarding and training activities as assigned.

Research Billing & Administrative Coordination

Supports accurate research billing and financial documentation related to assigned studies. Maintains required study visit and billing documentation, completes applicable research referral or billing forms, and works with appropriate research and administrative personnel to ensure study‑related services and charges are appropriately identified and documented.

Expected Salary

$59,000-$67,000

Required Qualifications

Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.

Preferred

Bachelor’s Degree in Nursing with current Florida licensure and clinical research experience; master's degree in an appropriate area of specialization; or a bachelor's degree in an appropriate area of specialization with relevant clinical research experience. Two or more years of experience coordinating clinical research studies, preferably involving HIV/AIDS, or infectious diseases.

Clinical research certification (e.g., CCRC, CCRP, or equivalent) preferred or ability to obtain certification within two years of hire.

Special Instructions To Applicants

This is a time‑limited position. Time limited positions are based on circumstances, such as funding sources, which control the length of time for which the position is available.

Background Check is Required.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.

Degrees earned from an education institution outside of the United States are required to be evaluated by a professional credentialing service provider approved by the National Association of Credential Evaluation Services (NACES), which can be found at http://www.naces.org/.

The University of Florida is a public institution and subject to all requirements under the Florida Sunshine and Public Records laws. Hiring is contingent upon eligibility to work in the US. Searches are conducted in accordance with Florida's Sunshine Law.

This requisition has been reposted. Previous applicants are still under consideration and need not reapply.

Health Assessment Required

yes