Clinical Research Coordinator 2

University of Miami•Miami, FL

About The Position

The Clinical Research Coordinator 2 serves as a mid-level clinical research professional that assists in the planning, coordinating, implementing, monitoring, and evaluating of specific clinical research studies. This role assists in the day-to-day operations of clinical research protocol implementation, and carries out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines. The incumbent works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, help with study-related administrative tasks, facilitate across-the-board flow of information, and coordinate study activities and personnel. Department Specific Functions Work with ID Research Unit Principal Investigator and Project Directors on on-going projects needs active multisite & single site research studies to meet deliverable deadlines. Serve as the lead coordinator to support research activities, coordinating visit assignments to clinical research coordinators, research associates, volunteers; and in leading regular team meetings, trainings, and protocol reviews. Participate in the review, revision, and implementation of standard operating procedures, and train new research personnel in study activities. Identify, screen, and recruit eligible participants according to inclusion and exclusion criteria. Obtain informed consent and explain study procedures to participants in a clear and ethical manner. Schedule, prepare, and conduct participant study visits in alignment with study protocols. Perform study assessments, including administering questionnaires, conducting interviews, and collecting clinical or behavioral data. Interface with laboratory staff to ensure timely processing and tracking of samples. Ensure completion and accuracy of all study visit forms, source documentation, and participant records. Support retention strategies, including participant outreach, appointment reminders, and community engagement activities. Maintain visit tracking logs and follow standardized operating procedures for visit documentation and quality control. Maintain and review study binders (QA/QC), visit schedules, and regulatory documents in compliance with institutional and sponsor requirements. Ensure participant confidentiality and data security according to IRB-approved procedures. 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.

Requirements

Bachelor’s degree in relevant field required
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.

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.
Work with ID Research Unit Principal Investigator and Project Directors on on-going projects needs active multisite & single site research studies to meet deliverable deadlines.
Serve as the lead coordinator to support research activities, coordinating visit assignments to clinical research coordinators, research associates, volunteers; and in leading regular team meetings, trainings, and protocol reviews.
Participate in the review, revision, and implementation of standard operating procedures, and train new research personnel in study activities.
Identify, screen, and recruit eligible participants according to inclusion and exclusion criteria.
Obtain informed consent and explain study procedures to participants in a clear and ethical manner.
Schedule, prepare, and conduct participant study visits in alignment with study protocols.
Perform study assessments, including administering questionnaires, conducting interviews, and collecting clinical or behavioral data.
Interface with laboratory staff to ensure timely processing and tracking of samples.
Ensure completion and accuracy of all study visit forms, source documentation, and participant records.
Support retention strategies, including participant outreach, appointment reminders, and community engagement activities.
Maintain visit tracking logs and follow standardized operating procedures for visit documentation and quality control.
Maintain and review study binders (QA/QC), visit schedules, and regulatory documents in compliance with institutional and sponsor requirements.
Ensure participant confidentiality and data security according to IRB-approved procedures.