Clinical Research Coordinator (CRC)

Job Description

Job Description

• Manage and analyze EKG and sleep data collect from subjects in confidential database
• Conduct consent discussions and other study procedures per protocol and CFR and GCP guidelines.
• Maintain strict patient confidentiality according to HIPPA regulations, GCP and ICH , 21 CFR and other regulatory documentation.
• Coordinate day-to-day study activities including data collection and statistical analysis, protocol development/implementation, and staff development.
• Ensure HIPAA privacy for clinical care compliance.
• Coordinate several studies in the areas of diabetes, dermatology and oncology.
• Coordinate and monitor regulatory procedures for clinical research per FDA standards.
• Maintain study documentation in accordance with FDA regulations.
• Develop and write individual patient data according to study sponsor protocol.
• Maintain study documentation to insure compliance with protocol and good clinical practice guidelines.
• Certify to administer study specific scales necessary to measure participate compliance, patient health, and study medicine efficacy.
• Enter data in EDC system and other required platforms.
• A minimum of 5 years experience is mendatory.