University of Miami
Clinical Research Coordinator 2
The Hussman Institute has an exciting opportunity for a 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-the-board flow of information, and coordinate study activities and personnel. Core Job Functions 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. Core Qualifications Bachelor's degree in relevant field required Minimum 2 years of relevant experience Department Specific Functions This position will focus on our genetic studies of African Ancestry in Alzheimer disease. The primary function of this job is to identify, recruit, and enroll Afro American/Afro Caribbean/African American individuals and families in the community of South Florida that would be eligible for our Alzheimer disease project. Once enrolled, the job requires the collection of biological samples and relevant clinical data from multiple sources depending on the study protocol. This will require travel to other cities throughout the United States. In addition to these activities, this job requires organization of and participation in community outreach activities to increase awareness of and interest in genetic research among underserved populations. The Clinical Research Coordinator is a member of the Section of Family and Patient Ascertainment within the John P. Hussmann Institute for Human Genomics.
The Hussman Institute has an exciting opportunity for a 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-the-board flow of information, and coordinate study activities and personnel. Core Job Functions 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. Core Qualifications Bachelor's degree in relevant field required Minimum 2 years of relevant experience Department Specific Functions This position will focus on our genetic studies of African Ancestry in Alzheimer disease. The primary function of this job is to identify, recruit, and enroll Afro American/Afro Caribbean/African American individuals and families in the community of South Florida that would be eligible for our Alzheimer disease project. Once enrolled, the job requires the collection of biological samples and relevant clinical data from multiple sources depending on the study protocol. This will require travel to other cities throughout the United States. In addition to these activities, this job requires organization of and participation in community outreach activities to increase awareness of and interest in genetic research among underserved populations. The Clinical Research Coordinator is a member of the Section of Family and Patient Ascertainment within the John P. Hussmann Institute for Human Genomics.