Clinical Research Coordinator 1

Current Employees

• If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this tip sheet. The Clinical Translational Research Site is currently seeking a full time Clinical Research Coordinator 1 to work in Miami. The Clinical Research Coordinator 1 serves as an entry level clinical research professional that has a basic foundation in clinical research through assigned responsibilities in data management or implementing clinical research protocols. This role exhibits increased learned skills and flexibility in performing duties and assumes responsibility for simple clinical research protocols and timelines.
• CORE
• RESPONSIBILITIES: Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to the protocol. Coordinates routine activities of clinical studies including data collection and maintenance, planning study timelines, schedules appointments and study visits, meeting scheduling, and project evaluation. Performs moderate to complex research tests/ experiments and adapts procedures for quality improvement under supervision. Understands and follows technical instructions for operating clinical research equipment, problem solves when operational failures occur. Assists in observing and informing the PI/supervisor of adverse events, including those reported by study participants. Addresses adverse events per protocol, advocating for study participants and quality standards throughout the lifespan of the study. Identifies, reports, and helps problem solve protocol deviations and unanticipated occurrences. Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies. Knows the contents and maintenance of study-specific clinical research regulatory binders. 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.
• CORE
• Qualifications:
• Education:
• Bachelor’s degree in relevant field
• Experience:
• Minimum 1 year of relevant experience
• Knowledge,
• Skills and
• Attitudes: 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. Department Specific Functions 1. Assists with participant recruitment and retention activities and screens potential study participants for eligibility. 2. Collects, processes, and ships specimens in accordance with protocol and regulations. 3. Maintains study binders and files in accordance with protocol requirements, UM, and department policy. 4. Distributes study drug materials in accordance with practice standards and clinical credentials, as delegated by the Principal Investigator. 5. Assists in implementing protocol amendments under the direct supervision of the Principal Investigator. 6. Assists with study orientation and protocol-related in-services for the research team and clinical staff. 7. Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; and submits progress reports according to the established schedule. 8. Learns the research team and assists with communications and interactions with sponsors, data coordinating centers, compliance monitors, collaborators, investigators’ academic and administrative personnel, and departments. 9. Assists with administrative tasks for study personnel, including orientation, documenting core competencies, certification mandates, safety and responsible conduct of research education, and performance reviews. 10. Adheres to cultural competency guidelines and implements strategies to meet study participants’ needs for language translation, health literacy, etc. 11. Follows the fundamental requirements of all international, national, and local regulatory bodies. 12. Local travel may be required.