Clinical Research Coordinator ; at University of Miami Miami, FL

Clinical Research Coordinator 2 (A)

The Hussman Institute has an exciting opportunity for a full‑time Clinical Research Coordinator 2 position. The incumbent 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‑board flow of information, and coordinate study activities and personnel.

Department:
John P. Hussmann Institute for Human Genomics, Section of Family and Patient Ascertainment.

• Assist in participant recruitment and retention activities, screen potential study participants for eligibility.
• Perform study procedures, routine tests, data collection/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 filings according to protocol requirements, UM 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/adverse events and protocol deviations.
• Assist in implementing protocol amendments under direct supervision of the Principal Investigator.
• Assist with study orientation and protocol related in‑services to research team and clinical staff.
• Monitor protocol implementation and study progress; keep investigators fully apprised of study progress; submit progress reports according to established schedule.
• Engage with sponsor, data coordinating centers, compliance monitors, collaborators, investigators’ academic administrative personnel, and departments to support study activities.
• Assist in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, safety/responsible conduct of research education, and performance reviews.
• Adhere to cultural competency guidelines; implement strategies to meet study participants’ needs for language translation, health literacy, and other support.
• Follow the appropriate fundamental requirements of all international, national, and local regulatory bodies.
• Maintain requisite 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.
• Support multiple genetics research studies by collecting, compiling, documenting, and analyzing clinical and genetic research data from study participants focused on Alzheimer disease in African ancestry communities.
• Organize, host, and participate in community education and outreach activities to recruit populations historically underrepresented in genetics research.
• Schedule and enroll participants, manage calendars and coordination with other staff.
• Coordinate enrollment activities, set up local and remote trips, including overnight travel when required.
• Collect biological samples per study protocols (draw blood, collect saliva).
• Collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests, and other sources; code, evaluate, interpret, and prepare documentation.
• Enter clinical data and develop strategies to maximize data entry efficiency; assist in preparation of clinical data reports and analyses; recommend new methods for collection and documentation; write and revise procedural manuals as required.
• Use data management and analysis software, including programs for drawing pedigree charts, basic statistical software, and query‑based extraction from relational databases.
• Function as a member of a…