Clinical Research Coordinator

Optimal Research Sites (ORS) is a growing clinical research site conducting industry-sponsored pharmaceutical trials. We are seeking an experienced Clinical Research Coordinator with active pharmaceutical research experience to join our onsite team in Orange City, Florida.

This is not an entry-level role. Candidates must have hands-on experience working on industry-sponsored pharmaceutical clinical trials.

Position Overview

The Clinical Research Coordinator (CRC) will oversee the day-to-day conduct of assigned clinical trials while ensuring strict adherence to protocol, ICH-GCP guidelines, sponsor expectations, and regulatory standards.

This role also requires independent lab processing and specimen shipment responsibilities.

Key Responsibilities

• Coordinate and manage pharmaceutical-sponsored clinical trials from startup through closeout
• Conduct subject visits per protocol requirements
• Perform informed consent process
• Collect, process, centrifuge, aliquot, and prepare laboratory specimens
• Package and ship laboratory specimens per sponsor guidelines
• Maintain laboratory logs, temperature logs, and equipment calibration documentation
• Enter data into EDC systems accurately and timely
• Maintain source documentation and regulatory binders
• Communicate effectively with sponsors, CROs, and monitors
• Support recruitment and retention initiatives
• Ensure audit and inspection readiness at all times

Required Qualifications

• Minimum 2 years of active pharmaceutical clinical research experience
• Direct experience with industry-sponsored pharmaceutical trials
• Current IATA certification (or willingness to obtain immediately upon hire)
• Experience processing and shipping research laboratory specimens
• Strong working knowledge of ICH-GCP
• Experience with EDC systems
• Strong organizational and documentation skills
• Must reside locally and be able to work onsite in Orange City, FL

Preferred Qualifications

• Phlebotomy experience
• Regulatory/start-up experience
• Multi-therapeutic area experience
• ACRP or SOCRA certification

Compensation & Benefits

• Competitive salary based on experience
• Paid Time Off (PTO)
• 401(k) plan
• Health and dental insurance options coming soon

Ideal Candidate

We are looking for a self-motivated, detail-oriented coordinator who can independently manage subject visits, lab processing, and sponsor communication in a fast-paced research environment.

Job Type: Full-time

Pay: $25.92 - $31.21 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Paid time off
• Retirement plan

License/Certification:

• IATA Certification (Required)

Work Location: In person