Clinical Research Coordinator 2

Responsibilities

• 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
• Support multiple genetics research studies by performing a variety of duties involved in the collection, compilation, documentation and analysis of clinical and genetic research data from study participants
• Organize, host, participate in community education, and outreach activities to recruit populations historically underrepresented in genetics research
• Identify, recruit, and enroll families for our genetic studies of Alzheimer disease in all Hispanic American individuals
• Schedule and enroll participants. This will require careful management of calendars and coordination with other staff
• Coordinate and manage enrollment activities for respective studies. This will entail setting up local and remote trips that will involve travel (including overnight travel, driving and air travel). This may require travel to participants in their homes or to medical clinics/hospitals
• Collect biological samples per study protocols. This will most frequently involve drawing blood or collecting saliva from participants
• Collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources; code, evaluate and interpret collected data and prepare appropriate documentation
• Enter clinical data and identify new strategies to maximize efficiency of data entry. Assist in preparation of clinical data reports and analyses; recommend new methods for collection and documentation of data; write and revise procedural manuals as required. Use data management and analysis software, including programs for drawing human pedigrees, basic statistical software and query-based extraction of clinical and laboratory data from relational database
• Function as a member of a multidisciplinary research team
• Prepare ascertainment reports for presentation to the investigative team
• Organize and manage the flow of information to and from participants and families; maintain contact information for families and participants; develop efficient strategies for following up with families on a regular basis
• Participate in regular clinical meetings and staff training sessions
• Ensure compliance with protocol guidelines and requirements of regulatory agencies; identify problems and/or inconsistencies and monitor patients’ progress to include documentation and reporting of adverse events; recommend corrective actions as appropriate
• Perform other related duties incidental to the work described herein

Preferred

• Fluent in English and Spanish

Benefits

• Comprehensive benefits package including medical, dental, tuition remission and more
• Glassdoor
• 3.9
• University of Miami is a public research university that provides undergraduate, graduate, and professional degree programs.
• Miami, Florida, USA
• https://welcome.miami.edu
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• Represents job field similar to this job
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Qualifications

• Bachelor's degree in relevant field required
• Minimum 2 years of relevant experience
• Fluent in English and Spanish

Required skills

• Bilingual English and Spanish, Biological sample collection, Clinical research coordination, Participant recruitment and enrollment, Regulatory compliance in clinical research

Preferred skills

• Fluent in English and Spanish

Experience

• 2+ years