Clinical Research Coordinator 257288

Medix™; Florida; On-site; USD 52,000 - 76,000; Full time

Job summary

Medix is seeking a Clinical Research Coordinator to manage day-to-day operations of clinical studies in compliance with GCP guidelines and regulatory requirements. You will serve as the primary liaison among the Principal Investigator, trial participants, sponsors, and the IRB, ensuring accurate documentation and study conduct.

Responsibilities include regulatory startup, IRB submissions, recruitment and consent, coordinating study visits, and data entry into EDC/CRFs, while resolving data

Qualifications

• Regulatory documents, study binders, IRB submissions/amendments.
• GCP guidelines and federal/institutional regulations awareness.
• Recruit eligible trial subjects following PI guidance.
• Maintain accurate regulatory / study documentation.

Responsibilities

• Regulatory startup & compliance with IRB processes.
• Coordinate sponsor visits, SIVs, IMVs, and audits.
• Screen and recruit eligible participants; obtain informed consent.
• Schedule and coordinate participant study visits from screening through closeout.
• Enter data into EDC/CRFs, verify source data, and resolve data queries.

Skills

Regulatory compliance

GCP knowledge

IRB submissions

Participant recruitment

Data management

Study coordination

Tools

EDC systems

CRFs

Job description

The Clinical Research Coordinator (CRC) manages the day-to-day operations of clinical research studies in compliance with study protocols, Good Clinical Practice (GCP) guidelines, and federal/institutional regulations. The CRC serves as a primary liaison between the Principal Investigator (PI), trial participants, sponsors, and the Institutional Review Board (IRB)

Study Startup & Regulatory Compliance:

• Prepare and maintain regulatory documents, study binders, and IRB submissions/amendments.
• Coordinate sponsor visits, site initiation visits (SIVs), monitoring visits (IMVs), and audits.

Participant Recruitment & Informed Consent:

• Screen, identify, and recruit eligible trial subjects.
• Obtain and document informed consent under the guidance of the PI.

Study Visits & Clinical Procedures:

• Schedule and coordinate participant study visits from screening through closeout.

Data Management:

• Collect, record, and verify patient source documents and enter data into Electronic Data Capture (EDC) systems or Case Report Forms (CRFs).
• Resolve data queries and track adverse events