Clinical Research Coordinator 2 - Division of Infectious Diseases

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The Department of Medicine, Division of Infectious Diseases has an exciting opportunity for a Clinical Research Coordinator 2.  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 will be supervised by the Director of the Miami CFAR Behavioral and Social Sciences Community Outreach Core. Day-to-day activities will be coordinated with the primary investigators of the clinical trials, who are outside of the University of Miami. 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 clinical research protocols. Conducts recruitment activities, including telephone calls to potential participants, pre-screening interviews over the phone. Obtains informed consent from study participant and answers questions about the study. Schedules appointments for study visits and study research activities including MRI and laboratory services. Collects data from study questionnaires and enters it onto computers. This includes neurocognitive assessments that will require training to conduct. Facilitates participant visits to different facilities on the UM Clinical Campus, including the Clinical Research Center and MRI facility. Works with the study data team to randomize participants to different interventions.  Trains participants on how to do the interventions.  This may involve downloading apps onto cell phones, training people about a wearable alcohol biosensor, training people to use a vagus nerve stimulator that is clipped onto an ear.  Participates in study team meetings both virtually and in person. Helps to evaluate any potential adverse events to study participants.  Document these in the research records. Ensures that clinical biospecimens (blood, urine, stool) are properly labeled and delivered to either a commercial laboratory or delivered to the biorepository on the UM campus Communicates and coordinates research activities with other research coordinators based at the University of Miami and other universities. Helps to provide payments to participants and keeps an enrollment log regarding patients for payment. Contact participants by phone or text to obtain additional study data.  Occasionally this may take place in an evening or weekend (not on a regular basis). Help to troubleshoot technology problems related to mobile apps, wearable biosensors, breathylyzers, nerve stimulators.  Many participants may not have much experience with this type of technology. Maintains study binders and filings according to protocol requirements, UM IRB and External IRB policy. Monitors, documents, reports, and follows-up on study unanticipated/adverse events and protocol deviations. Assists in implementing protocol amendments under direct supervision of the Study Principal Investigators. Assists with study orientation and protocol related in-services to research team and CTRS clinical staff. Monitors protocol implementation and study progress; keeps investigators fully apprised of study progress; submits necessary data and materials for preparing progress reports according to established schedule. Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. Assists in administrative tasks of study personnel including orientation, documenting core competencies, certification mandates, and safety/responsible conduct of research education.

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.

Minimum Requirements:

Bachelor’s Degree in relevant field required

Minimum 2 years of relevant experience

Knowledge, Skills and Attitudes:

• Skill in completing assignments accurately and with attention to detail.
• Ability to analyze, organize and prioritize work unde