Clinical Research Coordinator 2

University of Miami•Miami, FL

6d•Onsite

About The Position

The Hussman Institute is currently seeking a Full Time Clinical Research Coordinator 2 to work onsite in Miami.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 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. 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. Job Description 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. This position will focus on our genetic studies of Alzheimer disease in African Ancestry communities. 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 African Ancestry. 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). 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.

Requirements

Bachelor’s degree in relevant field required
Minimum 2 years of relevant experience
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.

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.
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 African Ancestry.
Schedule and enroll participants.
Coordinate and manage enrollment activities for respective studies.
Collect biological samples per study protocols.
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.