U

University of Miami

Research university in Coral Gables, FL

Clinical Research Coordinator 2

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeMiami, FL, USANo salary listedHybrid

About the Job

Requirements

  • A bachelor's degree in a relevant field is required.
  • A minimum of 2 years of relevant experience is required.
  • Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
  • Ability to work collaboratively with others and contribute to a team environment.
  • Skill in using office software, technology, and relevant computer applications.
  • Ability to communicate clearly in writing and verbally with colleagues and stakeholders.
  • Ability to complete 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

  • Conduct thorough phone calls with patients, triage patients, maintain the Department Chair’s calendar, and provide clerical or medical-related support for patient care and research.
  • Assist with patients, collect histories of new patients, and perform assessments under supervision of the Chair and other team specialists.
  • Refer eligible clinic patients to appropriate research studies and activities.
  • Organize and arrange community activities, including a speaker series and trainings, to advance the goals of the Tourette Association of America Center of Excellence.
  • Assist the Department Chair with document preparation for new grant submissions, literature reviews, article submissions to academic journals, chart reviews, data analysis, and PowerPoint and poster presentations.
  • Coordinate interventional and observational research projects, including participant recruitment, screening, assessments, follow-up assessments, data collection and management using electronic data capture systems, interaction with participants’ treatment teams, and preparation of participant reimbursements.
  • Ensure studies are conducted according to protocol design, report deviations, and maintain study files, including regulatory documents, correspondence, case report forms, and data files, in compliance with Good Clinical Practice and applicable requirements.
  • Perform regulatory compliance activities, including Institutional Review Board submissions and requirements issued by study sponsors and other regulatory entities.
  • Work with the Chair’s Executive Assistant to cover clinical administrative matters.
  • Assist in participant recruitment and retention and screen potential study participants for eligibility.
  • Perform study procedures, routine tests, data collection and recording, and daily operations of 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 and department policy.
  • 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 Principal Investigator’s direct supervision.
  • 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.
  • Learn the research team’s operations 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.
  • Adhere to cultural competency guidelines and implement strategies to meet participants’ needs for language translation, health literacy, and related support.
  • Follow applicable 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.
  • Adhere to University and unit-level policies and procedures and safeguard University assets.

About the Company

University of Miami

Research university in Coral Gables, FL

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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