Clinical Research Coordinator I

Responsibilities

• Lead coordinator on a study
• Execute follow-up visits ongoing studies
• Query resolution and other study specific tasks
• Perform station and instrumentation duties on other studies
• Respond to queries from Quality Assurance and Statistics departments
• Set up and conduct study in compliance with protocol, SOPs, applicable regulations and GCPs
• Prepare for and conduct pre-study meetings as well as other meetings and processes as deemed to protocol, SOPs and GCPs
• Maintain compliance with study budget
• Prepare, complete, organize and maintain of all study documentation forms, including drafting protocol amendments, case report forms, Electronic Data Capture (EDC), and other study specific documents
• Affirm that staff working on their managed studies understand and are performing duties according to protocol, SOPs and GCPs
• Coordinate scheduling subjects for visits
• Complete other duties or tasks assigned by Clinic Manager and/or Supervisor

Qualifications

• Associate degree or 2 years minimum of relevant work experience with a GED or High School Diploma
• Understands basic concepts in clinical research and capable of learning and performing duties during clinical studies
• Ability to manage and coordinate multiple projects in a fast-paced, highly professional environment