Clinical Research Coordinator 2 (Genitourinary -GU)

University of Miami•Miami, FL

6d•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 implementation of research protocols and study coordination from initiation through close-out in accordance with regulatory and sponsor guidelines. The coordinator works with study team members and other staff, faculty, and study sites to promote participant safety, adherence to approved protocols, completion of study administration, effective information flow, and coordination of study activities and personnel. The position is with the University of Miami/UHealth Department of SCCC and is based at UHealth in Miami, Florida. The University of Miami offers competitive salaries and a comprehensive benefits package, including medical, dental, tuition remission, and more.

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 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.

Responsibilities

Assist with participant recruitment and retention and screen potential participants for study 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 study unanticipated or adverse events and protocol deviations.
Assist with implementation of protocol amendments under the direct supervision of the Principal Investigator.
Assist with study orientation and protocol-related in-services for research team and clinical staff.
Monitor protocol implementation and study progress, keep investigators informed, and submit progress reports on schedule.
Learn the research team and 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, documentation of core competencies, certification mandates, safety and responsible-conduct-of-research education, and performance reviews.
Follow cultural competency guidelines and implement strategies to address participant needs such as language translation and health literacy.
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.