Role Overview
This contractor position plays a key role in supporting the execution of clinical trials by ensuring operational efficiency and regulatory adherence. The initial phase requires 3 months of onsite training, after which the role operates remotely. The Clinical Research Specialist ensures trial integrity through precise coordination of site activities, data systems, and compliance protocols.
Key Responsibilities
- Deliver training and ongoing support to clinical sites involved in the pill cam procedure, ensuring staff are proficient in trial-specific protocols
- Serve as the primary administrator for the Interactive Web Response System (IWRS), managing randomization processes and system coordination
- Organize and document meetings with study teams, including scheduling, minute-taking, and distribution of action items
- Maintain essential trial supplies and documentation, including colonoscopy forceps, shipping materials, and user guides
- Oversee logistical components of clinical trials in compliance with GCP, SOPs, and regulatory requirements
- Set up and manage clinical trial databases and tracking tools to ensure data accuracy and accessibility
- Support data management by compiling, tracking, and shipping Case Report Forms (CRFs) and responding to data queries
- Maintain the study data control table to ensure consistency across trial sites
- Review and approve monitoring reports using the Siebel system
- Perform updates on CTM software to maintain current system functionality
- Coordinate the archival of study-related documents in accordance with regulatory standards
- Conduct site visits for qualification, initiation, interim monitoring, and closeout, following SOPs, GCP, FDA, and ICH guidelines
- Support patient safety and welfare throughout the trial duration
- Ensure site-level compliance through active management and oversight
- Uphold data integrity in all reported trial outcomes
- Assist in launching study centers by verifying equipment availability and training staff to protocol standards
- Provide administrative support such as managing shipment records, training documentation, and inventory control
Technical Requirements
Proficiency with IWRS, Siebel, and CTM software is essential for daily operations and reporting.
Work Arrangement
This is a hybrid contractor role requiring an initial 3-month onsite commitment, followed by remote work. Flexibility and reliability in remote coordination are critical to ongoing trial support.
