Clinical Research Coordinator 3

Core Job Summary

The Clinical Research Coordinator 3 serves as an experienced clinical research professional responsible for providing leadership in the planning, implementing, monitoring, and evaluating of multiple clinical research protocols. This role manages multiple studies' daily operations, carries out study coordination duties from protocol development and initiation to study close-out according to regulatory/sponsor guidelines, assures each study’s integrity, and mentors less experienced Clinical Research Coordinators. The incumbent monitors and maximizes adherence to research standards and regulatory guidelines and approved operational procedures, works closely with study team members and other staff/faculty/study sites to ensure study participant safety and adherence to approved protocols, manages study-related administrative and human resources tasks, facilitates across-the-board flow of information, and orchestrates study activities and personnel.

Core Job 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.
• Captures, organizes, and analyzes data.
• Processes and handles confidential information with discretion.
• Works independently and/or in a collaborative environment.

Core Qualifications

• Education: Bachelor’s degree in relevant field required.
• Certification and Licensing: Current Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates for a minimum of 6 months. If you do not have the certification, you will have 6 months to obtain it.
• Experience: Minimum 4 years of relevant experience required.
• Knowledge, Skills and Attitudes: Skill in collecting, organizing and analyzing data.Ability to recognize, analyze, and solve a variety of problems.Ability to analyze, organize and prioritize work under pressure while meeting deadlines.Ability to process and handle confidential information with discretion.Ability to work independently and/or in a collaborative environment.

DEPARTMENT SPECIFICS

The Clinical Research Coordinator (CRC) will assist the Principal Investigator in the conduct all aspects of the clinical trial, including regulatory tasks, under the direct supervision of the Principal Investigator, and Clinical Research Manager. The CRC provides operational and administrative support in the management of patients accrued to multiple research protocols to assure subjects’ safety and regulatory compliance. The CRC is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, Standard Operating Procedures and all applicable regulations and guidelines and ensuring effective data flow associated with research protocols.

Department Information

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more. UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

Equal Opportunity Employer

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Job Status: Full time Employee Type: Staff