Clinical Research Coordinator 2

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The University of Miami/UHealth Department of Otolaryngology is currently seeking a full time Clinical Research Coordinator 2 to work on-site in Miami, FL.

CORE JOB FUNCTIONS

• Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility.

• Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols.

• Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations.

• Maintains study binders and filings according to protocol requirements, UM and department policy.

• Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator.

• Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.

• Assists in implementing protocol amendments under direct supervision of the Principal Investigator.

• Assists with study orientation and protocol related in-services to research team and clinical staff.

• Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule. Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and departments.

• Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews.

• Adheres to cultural competency guidelines; implements strategies to meet study participants’ needs for language translation, health literacy, etc.

• Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.

• Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.

• Adheres to University and unit-level policies and procedures and safeguards University assets.

Department Specific Functions

Serve as the primary Clinical Research Coordinator for the Pediatric Hearing Loss Outcomes & Interventions Lab, providing direct research support to the Principal Investigator, Dr. Ivette Cejas. Provide research coordination support to other Audiology Division investigators conducting pediatric hearing loss or implant-related research, as needed.

• Coordinate study activities including participant recruitment, scheduling, consent/assent, and communication with families in accordance with IRB-approved protocols.

• Perform REDCap development, data entry, management, and quality control, ensuring accuracy and completeness of research data.

• Assist with data management and analysis to support preparation of presentations, abstracts, and manuscripts.

• Support grant applications, regulatory submissions, and publication preparation, including tracking deadlines and formatting materials.

• Collaborate with Children’s Hearing Program faculty and staff to integrate research activities within clinical settings.

• Maintain regulatory compliance, including IRB submissions, continuing reviews, and study documentation.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

CORE QUALIFICATIONS                                                                                                    

Education:

Bachelor’s degree in relevant field

Experience: 

Minimum 2 years of relevant experience

Knowledge, Skills and Attitudes:

• Skill in completing assignments accurately and with attention to detail.