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The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Clinical Research Coordinator 3 to work at the UHealth medical campus in Miami, Fl.

CORE JOB SUMMARY
The Clinical Research Coordinator 3 (A) serves as 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. 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                                                                                                         

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 required

Experience: 

Minimum 4 years of relevant experience

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 Specific Functions

The Clinical Research Coordinator 3 (CRC3) plays a central role in implementing and managing complex clinical research protocols. This position requires strong leadership, organizational skills, and a solid foundation in research methods. The CRC3 will assist the Principal Investigator, Dr. Tracy Crane, and Director of Research for the CRANE Lab on oversight of study conduct from recruitment through data reporting, while serving as the primary steward of study data — ensuring its accuracy, integrity, and utility for scientific and public health impact. This role is a hybrid position with the option to work remotely for part of the week. This role may involve flexible hours at the discretion of the Director of Research, as it will involve covering research visits which may take place outside of usual business hours. This role will also involve travel to Sylvester Comprehensive Cancer Center satellite sites across Miami-Dade and Broward counties on an as needed basis to provide coverage for research staff in the lab. 

Key Responsibilities

Study Coordination and Oversight

Supports the PI and Research Director in the implementation of multiple complex clinical research protocols. Provides leadership in protocol implementation and study progress, keeping investigators apprised of milestones and barriers. Develops standard operating procedures (SOPs), study manuals, and templates with guidance from the Principal Investigator (PI) or Clinical Research Manager. Oversees and facilitates eligibility screening and study recruitment activities; develops and implements strategies to increase participant accrual. Plans and operationalizes strategies to monitor, document, report, and follow up on unanticipated occurrences and protocol deviations; develops and implements preventive and corrective actions. Organizes/manages site visits and internal/external auditing activities. Leads a Data Compliance team for the Crane Lab, supervising the tasks of junior CRCs as well as student interns and research assistants in the monitoring and quality review of study data. Follows all international, national, and local regulatory requirements and maintains mandatory research and compliance training. Adheres to University and unit-level policies and safeguards University assets.

Data Stewardship and Analytics

Serves as the primary custodian of study data, with responsibility for data integrity, version control, and secure access in compliance with regulatory and institutional requirements. Oversees database management, including data entry quality, data cleaning, error resolution, and alignment with the study data dictionary and coding standards. Generates curated data sets for investigators and collaborators while ensuring proper data use agreements and confidentiality protections. Conducts basic statistical analyses and prepares interim reports to track accrual, protocol adherence, and progress toward research outcomes. Creates data visualizations and dashboards to support real-time decision making by investigators, sponsors, and stakeholders. Collaborates with investigators, epidemiologists, and biostatisticians to refine study methodology, analytic approaches, and outcome measures. Identifies emerging patterns and trends in study data, providing insights that can inform clinical and public health research directions.

Scientific Dissemination and Scholarly Activity

Coordinates the compilation of information needed for research reports, sponsor updates, and peer-reviewed publications. Contributes data analyses, tables, figures, and methodological sections to manuscripts, posters, and conference presentations. Serves as lead or co-author on manuscripts, abstracts, and posters when appropriate, coordinating writing timelines and integrating feedback from co-authors. Conducts literature reviews, manages references, and ensures alignment with journal and conference submission standards. Develops strategies to disseminate findings to professional audiences, clinical personnel, and stakeholders, extending the visibility and impact of the research.

Department Specific Qualifications                                                                                     

Education:

Master’s degree in Epidemiology, Public Health, or similar

Experience:

Minimum 4 years relevant experience

Knowledge, Skills and Attitudes:

• Excellent organizational, communication, and leadership skills.
• Strong skills in data quality assurance, cleaning, and management of study datasets.

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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.

The University of Miami is an Equal Opportunity Employer - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.

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