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Lead Clinical Research Coordinator - Onsite (Miami)
Lead Clinical Research Coordinator - Onsite (Miami)SoTalent • Miami, FL, United States
No longer accepting applications
Lead Clinical Research Coordinator - Onsite (Miami)

Lead Clinical Research Coordinator - Onsite (Miami)

SoTalent • Miami, FL, United States
23 hours ago
Job type
  • Full-time
Job description

A prominent pediatric research organization is seeking an experienced Senior Clinical Trials Coordinator to take a lead role in the planning and execution of multiple ongoing and upcoming human subject research studies. This position will support a range of clinical investigations under the oversight of a centralized Clinical Trials Operations team and will play a key role in maintaining regulatory compliance, data quality, and participant safety throughout the research lifecycle.

This is a high-impact position offering the opportunity to work with cutting-edge clinical trials that support children and families, while also mentoring and guiding more junior research personnel.

Key Responsibilities :

  • Project Leadership & Oversight
  • Serve as the primary coordinator for several complex clinical trials, ensuring protocols are implemented accurately and efficiently.
  • Act as a central point of contact between investigators, research staff, regulatory personnel, sponsors, and monitoring organizations.
  • Monitor study progress and proactively identify and address operational bottlenecks or compliance risks.
  • Participant Management
  • Support participant recruitment efforts including eligibility screening, informed consent process, and enrollment procedures.
  • Maintain ongoing contact with participants and families, ensuring follow-up activities align with protocol requirements.
  • Data & Regulatory Compliance
  • Maintain high-quality source documentation and manage accurate, timely data entry into clinical trial management systems (CTMS).
  • Prepare and submit regulatory documents, amendments, and continuing review materials in collaboration with internal regulatory affairs teams.
  • Ensure data collection adheres to GCP (Good Clinical Practice) and local / institutional policies.
  • Mentorship & Team Support
  • Provide daily guidance and training to less experienced coordinators and assistants.
  • Assist with onboarding new staff and serve as a role model for protocol compliance, professionalism, and patient engagement.
  • Reporting & Communication
  • Compile and present updates on enrollment figures, site metrics, and project milestones to internal leadership.
  • Collaborate with finance, regulatory, and data teams to support audit readiness and funding compliance.
  • Attend investigator and operational team meetings to report on study status and address operational needs.

What Were Looking For :

Minimum Qualifications :

  • Bachelors degree in a scientific or health-related field OR at least 9 years of relevant clinical research experience.
  • A minimum of 5 years of hands-on experience coordinating human subject clinical trials.
  • Eligibility for clinical research certification (e.g., SOCRA or ACRP); must obtain within 12 months of hire.
  • Preferred Skills & Competencies :

  • Strong understanding of human subject protections, ICH-GCP guidelines, and FDA / IRB regulations.
  • Demonstrated ability to manage multiple trials simultaneously and maintain meticulous documentation.
  • Experience with CTMS platforms and data entry / reporting tools.
  • Proven success in mentoring or supervising others in a clinical research environment.
  • Bilingual (English / Spanish) proficiency is a plus.
  • Familiarity with pediatric clinical research protocols and participant interaction is highly valued.
  • Why Join Us :

  • Work at the forefront of clinical research in a patient-first environment.
  • Collaborate with multidisciplinary teams on studies that directly impact childrens health and wellness.
  • Be part of a mission-driven organization committed to advancing medical knowledge and access to innovative treatments.
  • Gain exposure to a diverse portfolio of research studies across therapeutic areas.
  • Supportive and collaborative work environment with professional growth opportunities.
  • Work Environment :

  • On-site engagement is required with flexibility for hybrid scheduling depending on study needs and organizational policy.
  • Interactions with patients, families, investigators, and external research stakeholders are a regular part of this role.
  • Please note : This job posting is just a preview of the full scope of the position. A comprehensive job description is shared by a member of our team.

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