Clinical Research Coordinator 1 (Population Sciences)

University of Miami•Miami, FL

19h•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 coordinator is responsible for simple clinical research protocols and timelines, performing participant recruitment and study coordination across Sylvester clinics and community partner sites in Miami-Dade County. The role requires regular local travel between clinic sites and work with healthcare clinics, physicians, nurses, investigators, and other study partners. The coordinator conducts in-person and remote informed consent, documents consent, builds and manages study records in REDCap, schedules and tracks participant assessments and follow-ups, and uses retention strategies to reduce loss to follow-up. The role also supports study regulatory compliance, data quality, reporting, preparation of study materials, maintenance of source documents and participant binders, and monitoring visits and audits. The coordinator communicates with participants’ care teams as specified by the protocol and keeps the study Program Manager informed of progress and barriers.

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 for interacting with colleagues and stakeholders.

Nice To Haves

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

Responsibilities

Perform chart reviews and prescreening to assess participant eligibility, coordinate simple clinical research protocols, and maintain protocol-based enrollment procedures.
Coordinate routine study activities, including data collection and maintenance, study timelines, appointments and visits, meeting schedules, and project evaluation.
Perform moderate to complex research tests and experiments and adapt procedures for quality improvement under supervision.
Follow technical instructions for operating clinical research equipment and troubleshoot operational failures.
Assist in observing and informing 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 applicable international, national, and local regulatory requirements and maintain study-specific regulatory binders.
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.
Maintain and expand collaborative relationships with community healthcare clinics, physicians, and nurses.
Assist investigators with preparation of IRB, NIH, and regulatory compliance reports.
Travel regularly to Sylvester clinics and community partner sites, including FQHC clinics across Miami-Dade County, to identify, recruit, screen, and consent participants in person.
Conduct informed consent in person and remotely, explain study aims, procedures, risks, and benefits, and document consent in REDCap.
Build and manage study records in REDCap, including record creation, survey distribution and completion, tracking reports, and participant communication tools.
Monitor study email accounts daily for new referrals and undelivered survey notifications.
Schedule, track, and complete participant assessment timepoints and follow-up contacts, and implement 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 regarding appointment adherence, care plan referrals, and changes in patient status as specified by the protocol.
Attend and prepare for recurring study meetings, including stakeholder meetings, coordinator check-ins, and working group sessions; keep the Program Manager informed of progress and barriers.
Prepare regular screening, enrollment, retention, and data-completeness reports 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 using good documentation practices; support monitoring visits and audits.
Request relevant medical records from participants’ oncology care teams, review them for study-related information, and update participant REDCap records accurately and promptly.