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Medix™ · 2 days ago

Lead Clinical Research Coordinator - 249543

Miami, FL

Contract

Onsite

Mid, Senior Level

$72K/yr - $95K/yr

5+ years exp

Medix™ is seeking a Lead Clinical Research Coordinator to support the operations of clinical trials at the investigator site. This role involves planning, coordinating, and executing clinical studies while ensuring compliance with various guidelines and regulations.

CrowdsourcingRecruitingSocial NetworkStaffing AgencyVenture Capital

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

Qualification

ICH/GCP knowledgeClinical research experienceMedical terminologyMicrosoft Office proficiencyBilingual in EnglishSpanishInterpersonal skillsCommunication skillsOrganizational skillsProblem-solving skillsTeam collaboration

Required

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

Bachelor's Degree Required

Minimum 5 years of clinical research coordinator experience, preferably with industry-sponsored trials

5+ Years of Clinical Research Coordinating Experience

Preferred

Certification as a Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) preferred, or willingness to obtain within 6 months of hire