Job Description

Lead Clinical Research Coordinator Opportunity in Miami, FL (33155)

Position Summary

The Clinical Research Coordinator plays an integral role in supporting the day-to-day operations of clinical trials at the investigator site. This position is responsible for planning, coordinating, and executing clinical studies in compliance with study protocols, contracted scope of work, ICH/GCP guidelines, sponsor and CRO requirements, and applicable local regulations.

Duties/Responsibilities

• Coordinate study startup activities, including site selection visits, source documentation setup, recruitment planning, and site preparation.
• Lead weekly site meetings and collaborate with site leadership to address facility and operational needs.
• Manage investigator signature processes and support subject recruitment, enrollment, and contingency planning.
• Monitor and track screening, enrollment, and study milestones, identifying barriers and implementing solutions.
• Partner with recruitment teams to improve enrollment for difficult-to-fill studies.
• Ensure timely and accurate data entry in EDC and clinical trial management systems, addressing discrepancies as needed.
• Participate in study initiation, monitoring, and close-out visits, including reviewing monitor reports and following up on action items.
• Conduct quality checks on subject visits and collaborate with compliance teams to address issues.
• Work with source documentation staff to ensure readiness for patient visits.
• Provide training, mentorship, and troubleshooting support to site staff; assist with onboarding new employees and evaluating training progress.
• Act as a liaison between site operations, financial teams, and leadership to improve workflows and communication.
• Develop and maintain strong investigator and sponsor relationships while providing progress updates.
• Participate in staff evaluations, candidate interviews, and employee development activities.
• Deliver presentations at training events and contribute to external collaborations for specialized study protocols.
• Support SOP development, special projects, business development initiatives, and team-building activities.
• Perform other duties as assigned.

Required Skills/Abilities

• Strong knowledge of medical terminology, ICH/GCP, and regulatory requirements.
• Excellent interpersonal, communication, and organizational skills.
• Proficiency with Microsoft Office, including Excel.
• Bilingual in English and Spanish, with strong written and verbal skills.
• Ability to work independently and collaboratively within a team.
• Strong problem-solving skills with the ability to maintain confidentiality and build effective working relationships.

Education/Experience

• Bachelor's Degree Required
• Certification as a Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) preferred, or willingness to obtain within 6 months of hire.
• Minimum 5 years of clinical research coordinator experience, preferably with industry-sponsored trials.

Additional Details

• Location: Miami, FL (33155)
• Position: Lead Clinical Research Coordinator
• Employment/Length of Assignment: Contracted position with the potential to be brought on permanent
• Hours: Monday-Friday; 8:30AM-5PM; Onsite 5 Days a Week
• Pay Range: $72,000-$95,000 Annual Salary (Dependent on background and years of experience)
• Requirements: 5+ Years of Clinical Research Coordinating Experience; Bachelor's Degree Required

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