Clinical Research Coordinator 2

University of Miami • Miami, FL

3d • Onsite

About The Position

The Department of Medicine at the University of Miami is hiring a full-time Clinical Research Coordinator 2 to work on the UHealth campus. This mid-level clinical research professional assists with planning, coordinating, implementing, monitoring, and evaluating clinical research studies. The role supports day-to-day protocol operations and coordinates studies from initiation through close-out in accordance with regulatory and sponsor guidelines. The coordinator works with study team members, staff, faculty, and study sites to promote participant safety and adherence to approved protocols, support study administration, facilitate information flow, and coordinate study activities and personnel.

The position supports active multisite and single-site studies in the ID Research Unit, working with the Principal Investigator and Project Directors to meet deliverable deadlines. As lead coordinator, the role coordinates visit assignments and supports research coordinators, research associates, and volunteers; leads team meetings, trainings, and protocol reviews; and helps review, revise, and implement standard operating procedures. The coordinator also trains new research personnel in study activities.

Requirements

• Bachelor’s degree in a relevant field.
• Minimum of 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 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 collaboratively.

Responsibilities

• Assist with participant recruitment and retention, and screen potential participants for eligibility.
• Perform study procedures, routine tests, data collection and recording, and daily operations for moderate-risk clinical research protocols.
• Collect, process, pack, and ship specimens according to protocols, standards, and regulations.
• Maintain study binders and filings according to protocol requirements and University and department policies.
• Distribute study drug materials as delegated by the Principal Investigator and in accordance with practice standards and clinical credentials.
• Monitor, document, report, and follow up on unanticipated or adverse events and protocol deviations.
• Assist with implementing protocol amendments under the direct supervision of the Principal Investigator.
• Assist with study orientation and protocol-related in-services for research team members and clinical staff.
• Monitor protocol implementation and study progress, keep investigators informed, and submit progress reports on schedule.
• Assist with communications and interactions with sponsors, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and departments.
• Assist with administrative tasks for study personnel, including orientation, competency documentation, certification mandates, safety and responsible-conduct-of-research education, and performance reviews.
• Apply cultural competency guidelines and strategies to address participant needs such as language translation and health literacy.
• Follow applicable international, national, and local regulatory requirements; maintain required safety, equality, responsible-conduct-of-research, continuing-education, and research-competency training.
• Follow University and unit-level policies and procedures and safeguard University assets.
• Work with the ID Research Unit Principal Investigator and Project Directors on ongoing multisite and single-site studies to meet deliverable deadlines.
• Serve as lead coordinator for research activities; coordinate visit assignments for coordinators, associates, and volunteers; and lead regular team meetings, trainings, and protocol reviews.
• Participate in reviewing, revising, and implementing standard operating procedures and train new research personnel.
• Identify, screen, and recruit eligible participants according to inclusion and exclusion criteria.
• Obtain informed consent and explain study procedures clearly and ethically.
• Schedule, prepare, and conduct participant study visits in alignment with study protocols.
• Conduct study assessments, including questionnaires, interviews, and collection of clinical or behavioral data.
• Coordinate with laboratory staff to ensure timely sample processing and tracking.
• Ensure study visit forms, source documentation, and participant records are complete and accurate.
• Support participant retention through outreach, appointment reminders, and community engagement activities.
• Maintain visit-tracking logs and follow standard procedures for visit documentation and quality control.
• Maintain and review study binders, visit schedules, and regulatory documents in compliance with institutional and sponsor requirements.
• Protect participant confidentiality and data security according to IRB-approved procedures.
• Perform other duties or responsibilities as necessary.

Benefits

• Competitive salaries.
• Comprehensive benefits package, including medical, dental, and tuition remission.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level