PER DIEM CLINICAL RESEARCH COORDINATOR

SRA Trials; Town of Florida (NY); On-site; USD 34,000 - 55,000; Full time

Job summary

Suncoast Research Associates seeks a Per Diem Clinical Research Coordinator to support daily operations at our Doral, FL site. The role covers visit preparation, room setup, data entry, and regulatory documentation in line with GCP/ICH guidelines.

The ideal candidate has hands-on clinical research experience, familiarity with EDC/CTMS systems, and strong attention to detail. Fluency in English/Spanish is a plus; flexible schedule required to cover varying study workloads.

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.
• Ability to perform accurate documentation, multitask effectively, and work independently with minimal supervision.
• Excellent communication, professionalism, and attention to detail.
• Phlebotomy experience strongly preferred (but not required).
• Bilingual English/Spanish is a plus.
• Available to work on an as-needed basis with varying schedules.
• Able to quickly learn study-specific protocols and site workflows.

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 per protocol and GCP.
• Maintain accurate documentation in source, eCRF/EDC systems, CTMS, and regulatory binders.
• Assist with specimen collection, processing, packaging, and shipment per lab manuals.
• Support coordinators with AE/SAE documentation, conmed changes, and assessments.
• Facilitate monitoring visits by data clarification, document retrieval, and query resolution.
• Maintain study supplies, inventory, and temperature monitoring documentation.
• Contribute to subject recruitment, including prescreening and outreach follow-up.
• Ensure compliance with SOPs, protocol procedures, ICH-GCP, and site quality standards.

Skills

Clinical research experience

ICH-GCP knowledge

FDA regulations

EDC/CTMS proficiency

Documentation & data entry

Communication skills

Bilingual English/Spanish

Flexible schedule

Phlebotomy (preferred)

Site workflows adaptation

Tools

EDC platforms

CTMS

IWRS/RTSM

ePRO/eDiary troubleshooting

Job description

Position:PER DIEM CLINICAL RESEARCH COORDINATOR

Location: Doral, FL

Job Id:144

# of Openings:1

Suncoast Research Associates is a privately owned and operated research organization established in 2018. We help volunteers get involved in clinical trials, which allow patients to play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research. Our company works with all major pharmaceutical companies and conducts studies in a myriad of therapeutic areas. We are located in Doral, Florida.

We are seeking a reliable, detail-orientedPer-Diem Clinical Research Coordinatorto support daily clinical trial operations at our investigative site. The ideal candidate has a strong working knowledge of GCP/ICH guidelines, study protocol procedures, and site-level workflows. This role provides supplemental support during high-volume periods, subject visits, monitoring visits, and other operational needs.

Key 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.

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.
• Ability to perform accurate documentation, multitask effectively, and work independently with minimal supervision.
• Excellent communication, professionalism, and attention to detail.
• Phlebotomy experience strongly preferred (but not required).
• Bilingual English/Spanish is a plus.
• Must be available to work on an as-needed basis, including flexibility to support varying schedules based on study and operational needs.
• Ability to quickly become familiar with study-specific protocols, procedures, and site workflows.
• Provide coverage and operational support to the clinical research team as needed based on site workload and scheduling demands.
• Assist with preparation for sponsor, CRO, and regulatory monitoring visits or audits, as applicable.
• Escalate protocol deviations, safety concerns, data discrepancies, or other study-related issues to the appropriate site personnel.

Join our team as a Per Diem Clinical Research Coordinator and play a critical role in supporting our research team.