Clinical Research Coordinator 2

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Clinical Research Coordinator 2

The University of Miami/UHealth department of Neurology has an exciting opportunity for a Full Time Clinical Research Coordinator 2 to work at the UHealth Medical Campus.

Core Summary

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.

Core 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.

Department Specific Functions

* Coordinates the implementation of multiple complex clinical research protocols.

* Develops SOPs and templates with guidance from the PI/Clinical Research Manager.

* Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual.

* Manages sample processing, packing, and shipping according to protocol, applicable standards, and regulations.

* Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences and protocol deviations.

* Develops and implements preventive/corrective actions.

* Develops, disseminates, and assures adherence to study-related clinical research best practices/scientific manuals.

* Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress.

* Provides leadership in identifying and working through ethical conflicts arising during protocol implementation, and refers these conflicts to the Research Ethics Team for consults as needed.

* Organizes/manages site visits and internal/external auditing activities as assigned.

* Coordinates research team meetings; assures communications across-the-board.

* Assures synchronization of study visits/procedures/ clinical tests with data collection schedules, established time-points; manages progress of study participants through protocol; expedites overall study progression.

* Coordinates the compilation of information needed for research reports; peer-reviewed publications; develops strategies to disseminate information to clinical personnel, professional audiences and stakeholders.

* 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.

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.

Core Qualifications

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