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 for assigned studies, clinic is set up at least 30 minutes prior to the study start
- Report to clinic on-time for all other studies
- 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 necessary by management
- Reviews and provides feedback on draft protocols, recruiting materials, and draft clinical study reports
- Coordinates scheduling subjects for visits
- Responds to queries from Quality Assurance and Statistics departments
- Orders checks for subject compensation
- Prepares and is accountable for all Test Material for managed studies
- Adheres to study budget
- Leads Training Workshops when applicable
- Initiate electronic questionnaire creation
- Assist in IRB and Regulatory Document submission/review
- Provides excellent customer service to clients and panelists and maintains a positive and respectful interaction with peers and supervisors.
- Complies with and understands safety and Operational Integrity procedures and processes.