Remote Site Monitor Central

hace 3 semanas


Xico, México Ppd A tiempo completo

Performs data review and mapping tasks as assigned by study project team leads that includes but is not limited to independently exporting, creating, executing, maintaining, and validating data transfer across multiple data management systems or operating systems, combining data from a variety of sources and structures, generating and storing summary data from a variety of sources, generating reports or combining multiple databases that generate output reports.Prepares and analyzes clinical trial patient datasets, such as laboratory data, vital signs data, tumor response data, imaging data, quality of life and well-being questionnaire data, or adverse events data, for clinical research purposes.Increases knowledge base and professional skills in areas including programming, technology and techniques, clinical trials, and the pharmaceutical industry by working closely with mentors, attending presentation / teaching events, and contributing to other general department documents and policies by assisting mentors with implementing best practice documents and articles.RSM-Central performs related activities on assigned project(s) in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and CRG SOPs.In addition, reviews study data from various sources remotely.They develop collaborative relationships with different stakeholders as applicable.Reviews ad-hoc clinical listings review, tracks and trends violations and deviations, site status, enrollment, CRF status and SAE follow up.Provides trial status tracking and progress update reports to study manager.Participates in the investigator payment process, if applicable.Assists in ensuring audit ready files and complying with CTMS and eTMF data stewardship.Contributes to company, client, and federal/local regulatory requirements/audit responses.- Bachelor's degree in life science-related field, IT, Engineer, Biostatistics or Programing.- Prior clinical research experience 0-1 year as well as knowledge of clinical monitoring through classwork/training that provides the required knowledge skills and abilities.In some cases, previous experience in a clinical environment where experience is gained in clinical trials, data management.**Skills**:- Firm understanding and use of Excel- Good attention to detail- Good problem solving skills- Good written and verbal communications skills to effectively interface with teams and clients, including proficiency in the English language- Capable of effectively organizing and managing multiple assignments with challenging timelines- Capable of adapting and adjusting to changing priorities- Positive attitude and the ability to work well with others- Demonstrated initiative and motivation- Firm understanding of relational data base structure and complex data systems- Capable of effectively capturing and reviewing data- Capable of providing quality control support


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