Clinical Research Coordinator Pathology Department - Miami, FL

Clinical Research Coordinator 2

The Department of Pathology has an exciting opportunity for a full-time Clinical Research Coordinator 2, to work on-site 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.

The Department of Pathology and Laboratory Medicine (DPLM) is a growing multi-disciplinary department at the University of Miami Miller School of Medicine. It encompasses 4 distinct divisions:
Anatomic Pathology, Hematopathology, Comparative Pathology, and Laboratory Medicine. DPLM Research includes all divisions and is divided according to basic, translational, and clinical research. The position of Clinical Research Coordinator 2 at DPLM is expected to conduct and support pathology research projects.

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.

Department Specific Job Functions

• Plan, implement, and monitor pathology clinical research study requests requesting pathology specific services.
• Participate in the development and revision of internal Standard Operating Procedures (SOP) in the delivery of pathology services Conduct all pathology research related requests, which includes searches using coPath, and managing faculty research databases using several software such as Qualtrics, Sharepoint, and REDCap.
• Keep faculty individual databases to capture all consult cases databases.
• Participate and coordinate new pathology research projects.
• Assist faculty with iLab requests for the Translational Research Histology Laboratory.
• Coordinate proper retrieval of pathology materials and ensure…