Senior CRC II: Lead Trials & Sponsor Collaboration

Florida Digestive Health Specialists, LLP; Bradenton (FL); Sur place; USD 55 000 - 85 000; Plein temps

Résumé du poste

Florida Digestive Health Specialist, LLP is seeking a Clinical Research Coordinator II to screen, enroll and follow study subjects ensuring protocol and regulatory compliance. This role increases study workload and Sponsor/CRO interaction while upholding FDHS standards.

The CRC II will coordinate study preparations, manage documentation and EDC entry, monitor safety, and collaborate with investigators and staff to advance multiple GI trials across FDHS sites.

Qualifications

• Three years clinical research experience.
• Experience coordinating CRC activities.
• Knowledge of FDA regulations and ICH guidelines.

Responsabilités

• Review protocol amendments for safety and feasibility.
• Discuss procedures and eligibility with investigators.
• Develop recruitment plans and materials.
• Recruit and prescreen candidates for studies.
• Enter data into EDC within 72 hours.
• Ensure product accountability and regulatory filings.
• Maintain FDA/ICH compliance throughout trials.
• Build relationships with participants and FDHS staff.

Connaissances

Clinical research

Regulatory compliance

Investigator coordination

Team collaboration

Patient interaction

Formation

RN license

LPN license

CCRC certification

Outils

MS Word

Excel

EDC systems

Clinical trials database

Description du poste

Florida Digestive Health Specialist, LLP is seeking a Clinical Research Coordinator II to screen, enroll and follow study subjects ensuring protocol and regulatory compliance. This role increases study workload and Sponsor/CRO interaction while upholding FDHS standards.

The CRC II will coordinate study preparations, manage documentation and EDC entry, monitor safety, and collaborate with investigators and staff to advance multiple GI trials across FDHS sites.