On-Call Clinical Research Coordinator (Per Diem)

Suncoast Research Associates, LLC; Town of Florida (NY); On-site; USD 46,000 - 83,000; Part time

Job summary

Suncoast Research Associates, LLC, a private research organization founded in 2018 and based in Florida, seeks a reliable Per Diem Clinical Research Coordinator to support daily trial operations at our investigative site. The role requires strong working knowledge of GCP/ICH guidelines, study protocols, and site workflows.

Responsibilities include conducting study visits, data entry, regulatory documentation, specimen handling, monitoring support, recruitment support, and ensuring compliance

Qualifications

• Minimum 3 years of hands-on clinical research experience.
• Strong understanding of ICH-GCP, FDA regulations, and protocol adherence.
• Proficiency with EDC platforms, CTMS, IWRS/RTSM systems, and ePRO/eDiary troubleshooting.
• Bilingual English/Spanish is a plus.

Responsibilities

• Assist with conducting study visits, including preparing visit materials, room setup, and subject flow management.
• Perform source documentation, data entry, and eDiary/ePRO troubleshooting in accordance with protocol and GCP.
• Maintain accurate, timely documentation in source, eCRF/EDC systems, CTMS, and regulatory binders as required.
• Assist with specimen collection, processing, packaging, and shipment per study-specific lab manuals (phlebotomy experience preferred).
• Support coordinators with tracking AE/SAE documentation, conmed changes, and protocol-mandated assessments.
• Facilitate monitoring visits by assisting with data clarification, document retrieval, and query resolution.
• Maintain study supplies, inventory logs, and temperature monitoring documentation.
• Contribute to subject recruitment efforts, including prescreening, chart review, and outreach follow-up.
• Ensure compliance with SOPs, protocol procedures, ICH-GCP, and site quality standards.

Skills

Clinical research

GCP/ICH knowledge

Multitasking

Communication

Independent work

Bilingual EN/ES (plus)

Tools

EDC platforms

CTMS

IWRS/RTSM systems

ePRO/eDiary

Job description

Suncoast Research Associates, LLC, a private research organization founded in 2018 and based in Florida, seeks a reliable Per Diem Clinical Research Coordinator to support daily trial operations at our investigative site. The role requires strong working knowledge of GCP/ICH guidelines, study protocols, and site workflows.

Responsibilities include conducting study visits, data entry, regulatory documentation, specimen handling, monitoring support, recruitment support, and ensuring compliance