Clinical Research Coordinator 1 (A)

University of Miami•Miami, FL

2d•Onsite

About The Position

The department of Medicine has an exciting opportunity for a full-time Clinical Research Coordinator 1 (A) to work onsite on the UHealth campus. The Clinical Research Coordinator 1 (A) serves as an entry-level clinical research professional that has a foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. The incumbent is responsible for simple clinical research protocols and timelines.

Requirements

Bachelor’s degree in relevant field
Minimum 1 year 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

Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols.
Maintains enrollment procedures according to the protocol.
Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation.
Performs moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision.
Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur.
Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants.
Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study.
Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences.
Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
Knows the contents and maintenance of study-specific clinical research regulatory binders.
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.
Supports regulatory and quality oversight activities by addressing audit and monitoring visit findings, responding to data queries, and assisting with corrective actions for protocol deviations under PI or senior staff guidance.
Establishes and maintains professional communication with research participants, clinical care teams, sponsors, and ancillary departments.
Provides study status updates to sponsors and regulatory bodies (e.g., IRB) as directed.
Conducts informed consent discussions for IRB‑approved studies, including drug and device trials, ensuring participant understanding and proper documentation per GCP and institutional requirements.
Performs clinical research procedures in accordance with study protocols and departmental training, including: Measurement of vital signs, Phlebotomy and specimen collection (blood, urine, sputum, BAL as applicable), Processing, aliquoting, storage, and shipment of biological samples.
Coordinates patient recruitment, screening, and follow‑up activities across inpatient and outpatient pulmonary settings.
Schedules protocol‑required visits and diagnostic testing, obtains medical records, and conducts participant follow‑up calls as required by the PI.
Performs and assists with pulmonary research assessments, including questionnaire administration, screening spirometry, setup and support of Pulmonary Function Tests (PFTs), electrocardiograms (ECGs), and 6‑minute walk tests (6MWTs), per protocol and departmental SOPs.
Maintains accurate research records and databases, including completion of source documentation, case report forms (CRFs), and electronic data entry to ensure data quality, completeness, and protocol compliance.