Clinical Research Coordinator

The University of Miami/UHealth Department of Anesthesiology has an exciting opportunity for a full-time Clinical Research Coordinator 2to work in Miami, FL. 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

• Minimum 2 years of relevant experience

• Skill in completing 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.

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South…