Clinical Research Coordinator II — Trials & Compliance

Intercoastal-Medical-Group; Sarasota (FL); On-site; USD 46,000 - 75,000; Full time

Job summary

Intercoastal Medical Group in Sarasota, FL is seeking a Clinical Research Coordinator II to oversee day-to-day management of clinical trials within healthcare settings. You will coordinate participant recruitment, consent, data collection, and ensure adherence to study protocols and regulatory requirements.

The role involves collaborating with investigators, sponsors, and regulatory bodies to facilitate study progress, maintain documentation, and monitor safety.

Qualifications

• High School Diploma or Equivalent required.
• Successful completion of an accredited medical assistant program, LPN, or RN program.
• At least 3 years of experience coordinating clinical research studies.
• Knowledge of FDA, IRB, and GCP regulations.
• Proficiency with electronic data capture systems and Microsoft Office.

Responsibilities

• Coordinate day-to-day activities of clinical research studies including recruitment, screening, enrollment and follow-up.
• Ensure compliance with study protocols, GCP, and regulatory requirements (FDA/IRB).
• Maintain accurate study documentation, including CRFs, regulatory binders, and EDC entries.
• Collaborate with principal investigators, research staff, and sponsors to advance study progress.
• Monitor participant safety and report adverse events per protocol and standards.
• Schedule study visits, collect samples, and perform study-related procedures as needed.
• Assist in regulatory submissions and study reporting.
• Train and mentor junior staff and support quality improvement.

Skills

Organizational skills

Communication

Attention to detail

Microsoft Office

Education

High School Diploma or Equivalent

Medical Assistant program

LPN program

RN program

Tools

Electronic Data Capture (EDC) systems

Microsoft Office Suite

Job description

Intercoastal Medical Group in Sarasota, FL is seeking a Clinical Research Coordinator II to oversee day-to-day management of clinical trials within healthcare settings. You will coordinate participant recruitment, consent, data collection, and ensure adherence to study protocols and regulatory requirements.

The role involves collaborating with investigators, sponsors, and regulatory bodies to facilitate study progress, maintain documentation, and monitor safety.