Work Location: Manatee County, Florida

Summary:

Seeking a Clinical Study Support Specialist to assist clinical research staff in the execution of clinical research trials, ensuring compliance with regulatory requirements and study protocols.

Responsibilities:

• Complete all required training, including GCP, IATA, and sponsor-specific modules, prior to participating in study activities.
• Maintain up-to-date knowledge of FDA regulations, GCP/ICH guidelines, SOPs, and study protocols to ensure compliance throughout the research process.
• Assist with accurate collection, recording, and management of patient data and biological samples, including timely shipment of specimens as required.
• Support the organization and maintenance of regulatory and administrative documentation, including protocol amendments, investigator brochures, and informed consent forms.
• Participate in patient visits, assist with source document creation, and ensure clear, concise, and accurate record-keeping for all assigned protocols.
• Assist in the reporting of adverse and serious adverse events, and help address findings from audits and monitoring visits in a timely manner.
• Be available for required meetings and monitoring visits, and utilize the most current study documents at all times.
• Provide general support for all aspects of study conduct and perform additional tasks as assigned by management.

Qualifications:

• High school diploma or equivalent required.
• Prior experience in clinical research preferred but not required.
• Phlebotomist certificate preferred.
• Medical Assistant Certification preferred.
• Knowledge of medical terminology required.
• Strong attention to detail and organizational skills.
• Excellent customer service and communication abilities.
• Proficient computer skills.

Published Category: Clinical Operations & Development