Clinical Research Coordinator 1 (A)

University of Miami•Miami, FL

2d•Hybrid

About The Position

The Department of Neurological Surgery at the University of Miami is seeking a hybrid, full-time Clinical Research Coordinator 1. This role serves as an entry-level clinical research professional with 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, performing moderate to complex research tests/experiments, and adapting procedures for quality improvement under supervision. The position also involves understanding and following technical instructions for operating clinical research equipment, assisting in observing and informing the PI/supervisor of adverse events, and addressing adverse events per protocol. The coordinator will identify, report, and help problem-solve protocol deviations and unanticipated occurrences, and ensure adherence to regulatory requirements and University policies.

Requirements

Bachelor’s degree in relevant field required
Minimum 1 year of relevant experience required
Refer to department description for applicable certification requirements
Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
Teamwork: Ability to work collaboratively with others and contribute to a team environment.
Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.

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.