Clinical Research Coordinator II at SGS — Richardson, TX

Responsible for coordinating and facilitating the daily activities that play a critical role of the clinical studies according to the protocol, Good Clinical Practices (GCP), Standard Operating Procedures (SOP), and Federal and applicable regulations.

• Sets up and conducts study in compliance with protocol, SOPs, applicable regulations and GCPs
• Prepares, completes, organizes and maintains of all study documentation forms, including drafting protocol amendments, case report forms, Electronic Data Capture (EDC), and other study specific documents
• Performs station and instrumentation duties on other studies as assigned, including the collection and recording of clinical information
• Assures that staff working on their managed studies understand and are performing duties according to protocol, SOPs and GCPs
• Assists in training and mentoring new clinic staff
• Prepares for and conducts pre-study meetings as well as other meetings and processes as deemed to protocol
• Reviews and provides feedback on draft protocols, recruiting materials, and draft clinical study reports
• Bachelor’s degree – preferably in science or other equivalent degree
• Understands basic concepts in clinical research and capable of learning and performing duties during clinical studies
• 2+ years relevant work experience or a combination of education and Work experience
• CCRC/CCRA certification a strong plus