Clinical Research Coordinator 1 (Population Sciences)

University of Miami•Miami, FL

2d•Onsite

About The Position

The Clinical Research Coordinator 1 is an entry-level clinical research professional who supports data management and implementation of clinical research protocols. The role is responsible for simple clinical research protocols and timelines and works at UHealth in Miami, Florida, within the University of Miami/UHealth Department of SCCC. The coordinator maintains and expands collaborative relationships with community healthcare clinics, physicians, and nurses. The role supports investigators with IRB, NIH, and regulatory compliance reports and travels regularly to Sylvester clinics and community partner sites, including Federally Qualified Health Center clinics across Miami-Dade County, for in-person participant identification, recruitment, screening, and consent. Consent may also be conducted remotely, and is documented in REDCap. The coordinator builds and manages study records in REDCap, distributes and tracks surveys, communicates with participants, and monitors study email accounts daily for referrals and undelivered survey notifications. The role schedules and tracks participant assessments and follow-ups, implements retention strategies, coordinates clinic space and workflows with site personnel, and communicates with participants’ clinical care teams as specified by protocol. The coordinator prepares for recurring study and stakeholder meetings, keeps the study Program Manager informed of progress and barriers, and prepares reports on screening, enrollment, retention, and data completeness. Responsibilities also include quality assurance checks, managing study materials and supplies across sites, maintaining source documents and participant binders, supporting monitoring visits and audits, and requesting and reviewing relevant medical records to ensure REDCap records are accurate and timely. The position includes chart review and eligibility prescreening; coordinating study procedures, data collection, and schedules; conducting research tests or experiments under supervision; operating clinical research equipment; monitoring and addressing adverse events, protocol deviations, and unanticipated occurrences; and following applicable regulatory requirements and study-specific documentation practices. The coordinator maintains required safety, equality, responsible conduct of research, continuing education, and research competency training.

Requirements

Bachelor’s degree in a relevant field.
At least 1 year of relevant experience.
Ability to learn new procedures, technologies, and protocols and adapt to changing priorities and work demands.
Ability to work collaboratively and contribute to a team environment.
Proficiency with office software, technology, and relevant computer applications.
Strong written and verbal communication skills.
Ability to travel locally between clinic and community partner sites is required.

Nice To Haves

Experience conducting research in community settings.
Experience recruiting and assessing cancer survivors.

Responsibilities

Perform chart review and prescreening to assess study participant eligibility and coordinate simple clinical research protocols.
Maintain participant enrollment procedures in accordance with study protocols.
Coordinate routine study activities, including data collection and maintenance, study timelines, appointments, study visits, meetings, and project evaluation.
Perform moderate to complex research tests or experiments and adapt procedures for quality improvement under supervision.
Operate clinical research equipment according to technical instructions and troubleshoot operational failures.
Observe and inform the PI or supervisor of adverse events, including events reported by participants.
Address adverse events according to protocol while advocating for participants and maintaining study quality standards.
Identify, report, and help resolve protocol deviations and unanticipated occurrences.
Follow requirements of applicable international, national, and local regulatory bodies and maintain study-specific regulatory binders.
Maintain mandatory safety, equality, responsible conduct of research, continuing education, and research competency training.
Maintain collaborative relationships with community clinics, physicians, and nurses.
Assist investigators with preparation of IRB, NIH, and regulatory compliance reports.
Travel to Sylvester clinics and community partner sites across Miami-Dade County to identify, recruit, screen, and consent participants.
Conduct informed consent in person and remotely, explain study aims, procedures, risks, and benefits, and document consent in REDCap.
Build and manage REDCap study records, create records, distribute surveys, track completion, use participant communication tools, and monitor study email accounts daily.
Schedule, track, and complete participant assessment timepoints and follow-up contacts, and implement participant retention strategies.
Coordinate with clinic champions, providers, nurses, medical assistants, and site administrators to arrange clinic space, equipment, and workflows for study activities.
Communicate with participants’ clinical care teams about appointment adherence, care plan referrals, and changes in patient status as specified by protocol.
Attend and prepare for recurring study meetings, stakeholder meetings, coordinator check-ins, and working group sessions; keep the Program Manager informed of progress and barriers.
Prepare reports on screening, enrollment, retention, and data completeness for the PI and Program Manager, and perform routine study data quality assurance checks.
Prepare and manage study materials and supplies across sites; maintain source documents and participant binders; support monitoring visits and audits.
Request and obtain relevant medical records from oncology care teams, review records for study-related information, and update participant REDCap records accurately and promptly.
Adhere to University and unit-level policies and procedures and safeguard University assets.