Clinical Research Coordinator 2

University of Miami•Miami, FL

18d•Onsite

About The Position

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. 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.

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.
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.