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The Department of Otolaryngology is currently seeking a full time Clinical Research Coordinator 3 to work in Miami, FL. 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
1. Coordinates the implementation of multiple complex clinical research protocols. 2. Develops SOPs and templates with guidance from the PI/Clinical Research Manager. 3. Oversees and facilitates eligibility screening and study recruitment activities; implements strategies to increase accrual. 4. Manages sample processing, packing, and shipping according to protocol, applicable standards, and regulations. 5. Plans and operationalizes strategies to monitor, document, report, and follow-up on unanticipated occurrences and protocol deviations. Develops and implements preventive/corrective actions. 6. Develops, disseminates, and assures adherence to study-related clinical research best practices/scientific manuals. 7. Assumes leadership in protocol implementation and study progress, keeping investigators apprised of study progress. 8. 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. 9. Organizes/manages site visits and internal/external auditing activities as assigned. 10. Coordinates research team meetings; assures communications across-the-board. 11. 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. 12. Coordinates the compilation of information needed for research reports; peer-reviewed publications; develops strategies to disseminate information to clinical personnel, professional audiences and stakeholders. 13. Follows the appropriate fundamental requirements of all international, national, and local regulatory bodies. 14. Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. 15. 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
Education:
Bachelor's degree in relevant field
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
Experience:
Minimum 4 years of relevant experience
DEPARTMENT ADDENDUM
Department Specific Functions
Purpose:
Clinical and outcomes research, coordination with translational and social science research; management of complex research data collection infrastructure; coordination and organization for clinical research involving patients with chronic and serious illness.
Position dimensions include:
Interfacing across departments; working with research subjects; data infrastructure management; helping with the development of research publications; contributing to grant applications; involvement with sponsored studies, training and supervision of research assistants and trainees.
Working Environmental Conditions:
Working on a collaborative research team with the PI, research assistants, and collaborators; liaison with informational technology and electronic medical record personnel; direct subject contact for consents and longitudinal follow-up, focus groups; videoconferencing meetings and in-person meetings.
The majority of work will be on the main UM medical campus with occasional travel to satellite clinics. May require intermittent evening or after hours commitments.
Department Specific Qualifications
Education:
Minimum education: experience in Medicine, Health Services, Public Health, or related fields. Graduate education encouraged.
Advanced Spanish Language and English fluency required.
Certification and Licensing:
Must have or obtain compliance with all Research certifications, including Good Clinical Practice and Blood borne pathogens.
Appropriate certifications and training in consenting patients, clinical research ethics, and regulatory research management
Experience:
3 or more years of minimum work experience in: Direct patient research, including consenting, quantitative methodological skills, database management, and experience with clinical research regulatory compliance.
Capacity to independently run day-to-day operations for complex research studies. Experience working with patients.
Knowledge, Skills and Attitudes:
Contributes to clinical and applied research activities including data collection, consenting patients, longitudinal patient follow-up, subject tracking, maintaining regulatory compliance, IRB submissions and modifications, and authors technical and agency reports.
Collaborates with the PI and senior staff on the development of research publications.
Creates and conducts clinical research and basic descriptive analysis of the results.
Manages clinical databases
Run day-to-day operations for large complex research studies, including PI-driven research, grant-funded research, and sponsored studies
Assists the PI and senior staff in preparing materials for submission to granting agencies and foundations.
Provides ready access to all experimental data for senior staff and research team
Requests or acquires equipment and supplies for assigned project(s).
Uses the Internet, surveys, databases, electronic medical record, and other available sources to collect research information.
Interfaces across departments with research collaborators, and funding agencies.
Participation in new skill development
Assist with qualitative research
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.
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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.
Patient safety is a top priority. As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.
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