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Clinical Data Specialist
1 week ago
Imaging Endpoints is a leading Clinical Research Organization (CRO) dedicated to advancing imaging science and technology in the pursuit of cures. As a Clinical Data Coordinator, you will play a crucial role in our mission by ensuring the seamless management of clinical data for our clients.
About the Role
We are seeking a highly organized and detail-oriented individual to assist in the coordination of clinical data management activities for assigned studies. This includes coordinating with study team members, management, and clients to complete work as detailed in client work orders; maintaining audit readiness by ensuring study-related documents are in the study eTMF in a timely manner; effectively communicating project status to internal and external stakeholders; and conducting clinical data management activities per relevant standard operating procedures and work instructions as directed by management.
The ideal candidate will have excellent communication skills, be able to multitask, and work under pressure. Additionally, they will possess strong time management and organizational skills, prioritizing workload to meet the changing needs of the day-to-day business.
This position requires a strong attention to detail and ability to grasp new concepts quickly.
A bachelor's degree in a related field or equivalent combination of education and relevant work experience is required. At least one year of prior clinical data management experience is also necessary.Your Responsibilities
Assist in processing radiological images received for client projects according to standard operating procedures. Enter clinical trial data into data collection tools. Conduct quality control review of clinical trial data. Generate, track, and close queries for images, reports, CRFs, eCRFs, as applicable. Conduct data/image transfers, as applicable. Monitor radiology readers for applicable on-site reads. Track conduct of DE/QC activities. Generate and/or quality control review Diagnostic and Summary Reports. Support data analysis activities. Support database lock activities. Support study closeout and reconciliation activities. Conduct UAT activities for data collection and transfer systems/tools. Maintain both paper and electronic project files in accordance with standard operating procedures. Advocate compliance with all standard operating procedures. Contribute to generation of Study Specific Procedures (SSPs). Contribute to generation study specific reports. Contribute to generation of study specific data collection tools/databases. Assist Clinical Data Managers with any requested task. Assist with training and monitoring of Clinical Data Coordinator I. Update appropriate study team members and management with task, deliverable, and project statuses.