Responsibilities include but are not limited to being lead coordinator on a study, executing follow-up visits ongoing studies, query resolution and other study specific tasks. The CRC I will perform daily tasks such as document review, data entry, test material preparation and data collection. This position may coordinate and execute projects assigned by the Clinic Manager while abiding by Good Clinical Practice (GCP) guidelines.
JOB FUNCTIONS
- Performs station and instrumentation duties on other studies as assigned, including the collection and recording of clinical information
- Responds to queries from Quality Assurance and Statistics departments
- Sets up and conducts study in compliance with protocol, SOPs, applicable regulations and GCPs
- Prepares for and conducts pre-study meetings as well as other meetings and processes as deemed to protocol, SOPs and GCPs
- Monitor Compliance of panelists
- Prepares and is accountable for all Test Material for managed studies
- Adheres to study budget
- 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
- Assures that staff working on their managed studies understand and are performing duties according to protocol, SOPs and GCPs
- Coordinates scheduling subjects for visits
- Completes other duties or tasks assigned by Clinic Manager and/or Supervisor
JOB COMPLEXITY
IMPACT OF DECISIONS
- Make decisions as a study leader
ANALYTICAL THINKING/PROBLEM SOLVING
- Handle issues with panelists and create solutions
- Arrange work for studies