Clinical Research Coordinator 2

University of Miami•Miami, FL

5d•Onsite

About The Position

The Hussman Institute is seeking a full-time, onsite Clinical Research Coordinator 2 in Miami. This mid-level clinical research professional supports the planning, coordination, implementation, monitoring, and evaluation of clinical research studies. The role manages day-to-day protocol operations and study coordination from initiation through close-out, working with study teams, staff, faculty, and study sites to support participant safety, protocol adherence, administrative tasks, information flow, and coordination of study activities and personnel. The position supports multiple genetics research studies, with a focus on Alzheimer disease in African Ancestry communities. It identifies, recruits, and enrolls eligible individuals and families, particularly Afro American, Afro Caribbean, and African American community members in South Florida. Responsibilities include community education and outreach, scheduling and coordinating enrollment, collecting biological samples and clinical data, and managing participant and family communications. The role may involve travel to other U.S. cities, including overnight travel, and visits to participants' homes or medical facilities. The coordinator collects and documents clinical and genetic research data from sources such as medical records, interviews, questionnaires, and diagnostic tests; maintains study records; supports data entry, reports, and analyses; and helps ensure compliance with protocols and regulatory requirements. The position is part of the Section of Family and Patient Ascertainment within the John P. Hussmann Institute for Human Genomics and functions as a member of a multidisciplinary research team.

Requirements

Bachelor's degree in a relevant field.
At least 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.
Ability to work independently and/or collaboratively.
Commitment to the University's core values.

Responsibilities

Assist with participant recruitment and retention and screen potential participants for eligibility.
Identify, recruit, and enroll eligible individuals and families in genetic studies of Alzheimer disease in African Ancestry communities.
Organize, host, and participate in community education and outreach activities to increase awareness of and interest in genetic research.
Schedule participants and manage calendars and coordination with other staff.
Coordinate enrollment activities, including arranging local and remote trips and travel to participant homes, clinics, and hospitals.
Perform study procedures, routine tests, data collection, and daily operations of moderate-risk clinical research protocols.
Collect, process, package, and ship specimens according to study protocols, standards, and regulations; this most often involves drawing blood or collecting saliva.
Collect clinical data from patient charts, medical records, interviews, questionnaires, diagnostic tests, and other sources; code, evaluate, interpret, and document the data.
Enter clinical data, identify ways to improve data-entry efficiency, and assist with clinical data reports and analyses.
Recommend methods for collecting and documenting data, and write or revise procedural manuals as needed.
Use data management and analysis software, including human pedigree drawing programs, basic statistical software, and query-based tools for extracting clinical and laboratory data from relational databases.
Maintain study binders and files according to protocol requirements and University and department policies.
Distribute study drug materials as delegated by the Principal Investigator and consistent with practice standards and clinical credentials.
Monitor, document, report, and follow up on unanticipated or adverse events and protocol deviations; monitor participant progress and recommend corrective actions as appropriate.
Assist with protocol amendments under the direct supervision of the Principal Investigator.
Monitor protocol implementation and study progress, keep investigators informed, and submit progress reports on schedule.
Prepare ascertainment reports for presentation to the investigative team.
Organize and manage information flow to and from participants and families, maintain contact information, and develop strategies for regular follow-up.
Assist with study orientation and protocol-related in-services for research team members and clinical staff.
Assist with study personnel administration, including orientation, core competency documentation, certification mandates, safety and responsible-conduct-of-research education, and performance reviews.
Communicate and interact with sponsors, data coordinating centers, compliance monitors, collaborators, investigators' academic administrative personnel, and departments.
Participate in clinical meetings and staff training sessions and function as a member of a multidisciplinary research team.
Apply cultural competency guidelines and strategies to address participants' language translation and health literacy needs.
Follow applicable international, national, and local regulatory requirements and maintain required safety, equality, responsible conduct, continuing education, and research competency training.
Adhere to University and unit-level policies and procedures and safeguard University assets.
Perform other related duties as assigned.