U

University of Miami

Research university in Coral Gables, FL

Clinical Research Coordinator 2

Full-Time
No salary listed
Mid
Bachelor's
Miami, FL, USA
In PersonTravel across different locations may be necessary.
Biology & BiotechClinical Research Operations
Company Does Not Provide H1B Sponsorship

About the job

Requirements
  • A bachelor's degree in a relevant field.
  • At least two years of relevant experience.
  • Complete assignments accurately and with attention to detail.
  • Analyze, organize, and prioritize work under pressure while meeting deadlines.
  • Handle confidential information with discretion.
  • Work evenings, nights, and weekends as necessary.
  • Work independently and/or collaboratively.
Responsibilities
  • Assist with participant recruitment and retention and screen potential study 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 files according to protocol requirements and University of Miami 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 implementing protocol amendments under the direct supervision of the Principal Investigator.
  • Assist with study orientation and protocol-related in-services for the research team and clinical staff.
  • Monitor protocol implementation and study progress, keep investigators apprised of progress, and submit progress reports on schedule.
  • Assist with communications and interactions with sponsors, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and departments.
  • Assist with study personnel administration, including orientation, documenting core competencies and certification mandates, and tracking safety, responsible conduct of research education, and performance reviews.
  • Implement strategies to meet study participants’ needs for language translation and health literacy, following cultural competency guidelines.
  • Follow requirements of international, national, and local regulatory bodies.
  • 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.
  • Travel across different locations if necessary.

About the company

The University of Miami is a private research university focused on education, discovery, and service, with undergraduate, graduate, and professional programs.

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