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University of Miami · 6 days ago

Clinical Research Coordinator 3

Miami, FL

Full-time

Hybrid

Mid, Senior Level

4+ years exp

The University of Miami is a leading academic medical center, and they are seeking a Clinical Research Coordinator 3 to oversee complex clinical research protocols. This role involves managing study operations, ensuring compliance with regulatory standards, and mentoring junior coordinators while maintaining data integrity and facilitating communication among research teams.

Higher Education

Responsibilities

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

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

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

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

Qualification

Clinical Research CoordinationData ManagementStatistical AnalysisSOP DevelopmentEpidemiology KnowledgeLeadership SkillsOrganizational SkillsCommunication SkillsProblem SolvingConfidentiality HandlingCollaboration

Required

Bachelor's degree in relevant field

Current Research Coordinator certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates for a minimum of 6 months required

Minimum 4 Years Of Relevant Experience

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