Clinical Research Coordinator 2

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The department of Medicine has an exciting opportunity for a full-time Clinical Research Coordinator 2 to work on the UHealth campus. 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.

CORE 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 stand6ards 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

• Supports recruitment, prescreening, and enrollment of participants across pulmonary, critical care, and sleep medicine clinical trials, including studies involving COPD, asthma, ILD, bronchiectasis, and sleep disorders.
• Coordinates and performs study visits and procedures in accordance with protocol requirements, including pulmonary function testing coordination (PFTs), six-minute walk tests, biospecimen collection, and patient-reported outcome assessments.
• Oversees collection, processing, storage, and shipment of biological specimens (blood, sputum, etc.) following sponsor protocols, IATA guidelines, and institutional policies.
• Maintains accurate and audit-ready regulatory binders and study files in accordance with UM, sponsor, and FDA/ICH-GCP requirements.
• Supports investigational product (IP) handling and accountability (when applicable), including coordination with IDS/pharmacy and ensuring proper documentation per protocol.
• Monitors, documents, and reports adverse events (AEs/SAEs), protocol deviations, and unanticipated problems, ensuring timely reporting to sponsors, IRB, and regulatory bodies.
• Implements protocol amendments, including updating study documents, revising workflows, and reconsenting participants as needed under PI supervision.
• Coordinates study startup and ongoing operations, including assisting with site initiation visits (SIVs), monitoring visits, and audit readiness activities.
• Tracks study progress, enrollment, and data entry timelines; ensures investigators are regularly updated and milestones are met across multiple active protocols.
• Serves as a point of contact for sponsors, CROs, monitors, and internal collaborators; supports effective communication and issue resolution across cross-functional teams.
• Performs timely and accurate data entry into EDC systems (e.g., Medidata, REDCap), resolves data queries, and ensures source documentation is complete and consistent.
• Collaborates with clinical teams (physicians, RTs, nurses) to coordinate protocol-required procedures during routine patient care and research visits.
• Ensures compliance with all applicable regulatory requirements, including FDA, ICH-GCP, HIPAA, and institutional policies governing human subjects research.

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

• Bachelor’s degree in relevant field required
• Minimum 2 years of relevant experience required

Knowledge, Skills and Abilities:

• Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
• Ability to work collaboratively with others and contribute to a team environment.
• Skilled in using office software, technology, and relevant computer applications.
• Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

Job Status:

Full time

Employee Type:

Staff