Clinical Research Coordinator 2

University of Miami•Miami, FL

1d•Onsite

About The Position

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. This role serves 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. The position also provides research coordination support to other Audiology Division investigators conducting pediatric hearing loss or implant-related research, as needed. The role involves coordinating study activities including participant recruitment, scheduling, consent/assent, and communication with families in accordance with IRB-approved protocols. Additionally, it includes REDCap development, data entry, management, and quality control, as well as assisting with data management and analysis to support preparation of presentations, abstracts, and manuscripts. The coordinator will also support grant applications, regulatory submissions, and publication preparation, and collaborate with Children’s Hearing Program faculty and staff to integrate research activities within clinical settings. Maintaining regulatory compliance, including IRB submissions, continuing reviews, and study documentation, is also a key responsibility.

Requirements

Bachelor’s degree in relevant field
Minimum 2 years of relevant experience
Skill in completing assignments accurately and with attention to detail.
Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
Ability to process and handle confidential information with discretion.
Ability to work evenings, nights, and weekends as necessary.
Commitment to the University’s core values.
Ability to work independently and/or in a collaborative environment.
Strong communication skills.
Ability to interact effectively, compassionately, and professionally with children and their families from diverse cultural, linguistic, and socioeconomic backgrounds.
Ability to collaborate with families and clinical teams to support scheduling, follow-up, and adherence to research protocols.

Nice To Haves

Bilingual preferred

Responsibilities

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.
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.