Clinical Research Coordinator 2 (Genitourinary -GU)

University of Miami•Miami, FL

7d•Onsite

About The Position

The Clinical Research Coordinator 2 is a mid-level clinical research professional who assists with planning, coordinating, implementing, monitoring, and evaluating clinical research studies. The role supports day-to-day protocol implementation and carries out study coordination from protocol initiation through study close-out in accordance with regulatory and sponsor guidelines. The coordinator works with study teams, staff, faculty, and study sites to support participant safety and adherence to approved protocols, manage study-related administrative tasks, facilitate information flow, and coordinate study activities and personnel. This position is with the University of Miami/UHealth Department of SCCC and is based at UHealth in Miami, Florida. The position is full-time. A bachelor’s degree in a relevant field and at least two years of relevant experience are required. The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, and tuition remission.

Requirements

Bachelor’s degree in a relevant field.
At least 2 years of relevant experience.
Ability to learn new procedures, technologies, and protocols and adapt to changing priorities and work demands.
Ability to collaborate with others 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.

Responsibilities

Assist with participant recruitment and retention and screen potential participants for eligibility.
Perform study procedures, routine tests, data collection and recording, and daily operations for moderate-risk clinical research protocols.
Collect, process, pack, and ship specimens according to protocol, applicable standards, and regulations.
Maintain study binders and filings according to protocol requirements and University and department policies.
Distribute study drug materials according to practice standards and clinical credentials, as delegated by the Principal Investigator.
Monitor, document, report, and follow up on unanticipated or adverse study events and protocol deviations.
Assist with implementing protocol amendments under the direct supervision of the Principal Investigator.
Assist with study orientation and protocol-related in-services for research team members and clinical staff.
Monitor protocol implementation and study progress, keep investigators informed of progress, and submit scheduled progress reports.
Assist with communications and interactions with sponsors, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and departments.
Assist with administrative tasks for study personnel, including orientation, documenting core competencies, certification mandates, safety and responsible-conduct-of-research education, and performance reviews.
Follow cultural competency guidelines and implement strategies to address participants’ needs for language translation, health literacy, and related support.
Follow applicable international, national, and local regulatory requirements.
Maintain required skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
Follow University and unit-level policies and procedures and safeguard University assets.