Internship program providing learning experience, mentoring and work experience in clinical trials, supporting regulatory, finance and supply functions.
Responsibilities
Prepare, collate, distribute and archive clinical documents
Support clinical supply and non-clinical supply management
Maintain tracking and reporting tools
Update clinical trial databases (CTMS) and trackers
Coordinate labeling requirements and translation change requests
Requirements
B.A./B.S. (Life Science preferred) or equivalent healthcare experience
Supports trial-level external-data activities, authoring and maintaining transfer specifications, coordinating with service providers/IT for accurate ingestion, performing completeness, reconciliation, and traceability checks, and supporting audit/inspection preparation.
Responsibilities
Gather external data requirements from protocols, service providers, and study stakeholders.
Develop external data specifications in accordance with standards, obtaining required stakeholder approvals.
Execute test and first-production file reviews to confirm adherence to approved external data specifications.
Monitor external data file loads, review error logs, and resolve or escalate issues as appropriate.
Support Specimen Lifecycle Management reconciliation and external data validation to ensure data are review- and lock-ready for CDM.
Clinical Data Specialists deliver quality solutions to hospital partners across the country through data abstraction and clinical quality data management.
Compensation
USD $23.00 - USD $27.00 /Hr.
Responsibilities
Apply specialized knowledge to hospital partners: categorize, code, summarize, interpret and calculate registry/case information from nuanced, patient medical records.
Ensure quality submission of all data in specified registries or measure data repositories, maintaining a high accuracy threshold.
Prioritize, organize, and meet tight deadlines for multiple concurrent tasks and team requests; uses tact and judgement to manage expectations, flag obstacles and propose solutions in a timely manner.
Navigate technical systems: electronic medical records (EMR) and registry/case entry tools; use team resources to troubleshoot technical issues with systems and applications with a focus on solutions.
Contribute to team best practices, data dictionaries, abstraction guidelines, and other business rule documents; identifies process improvement opportunities to help streamline tasks and processes.
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