University of Miami-posted 3 days ago
Full-time • Mid Level
Onsite • Miami, FL
11-50 employees

The department of Medicine has an exciting opportunity for a full-time Clinical Research Coordinator 2 to work onsite on the UHealth campus. The Clinical Research Coordinator 2 serves as a mid-level clinical research professional that assists in the planning, coordinating, implementing, monitoring, and evaluating of specific clinical research studies. This role assists in the day-to-day operations of clinical research protocol implementation and carries out study coordination duties from protocol initiation to study close-out according to regulatory/sponsor guidelines. The incumbent works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, help with study-related administrative tasks, facilitate across-the-board flow of information, and coordinate study activities and personnel.

  • Assists in participant recruitment and retention activities and assists in screening potential study participants for eligibility.
  • Performs study procedures, routine tests, data collection/recording, and daily operations of moderate risk clinical research protocols.
  • Collects, processes, packs, and ships specimens according to protocol, applicable standards and regulations.
  • Maintains study binders and filings according to protocol requirements, UM and department policy.
  • Distributes study drug materials according to practice standards and clinical credentials as delegated by the Principal Investigator.
  • Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations.
  • Assists in implementing protocol amendments under direct supervision of the Principal Investigator.
  • Assists with study orientation and protocol related in-services to research team and clinical staff.
  • Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits progress reports according to established schedule.
  • Learns the research team and assists with communications/interactions with sponsor, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and departments.
  • Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews.
  • Adheres to cultural competency guidelines; implements strategies to meet study participants’ needs for language translation, health literacy, etc.
  • Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies.
  • 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.
  • This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
  • Bachelor’s degree in relevant field required
  • Minimum 2 years of relevant experience required
  • Knowledge, Skills and Abilities:
  • 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.
  • The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
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