Pedestal Health generates complete, longitudinal datasets with advanced analytics and vigorous causal inference methodologies to uncover deep insights on unmet needs, disease progression, and the efficacy and safety of new treatments in the real world. Backed by North Carolina Biotechnology Center.
About the role
Pedestal Health is seeking a Senior Clinical Research Associate to conduct site management and data monitoring of assigned clinical sites, ensuring all activities are conducted in accordance with applicable Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs). In addition to core monitoring responsibilities, the Senior CRA serves as a mentor to other CRAs and as a technical subject matter expert within the organization.
What they're looking for
- Conduct remote site selection visits (PSVs) to evaluate whether facilities and staff are adequate for conducting the study
- Conduct remote site initiation visits (SIVs) to ensure sites and study staff are adequately trained and prepared to conduct the study
- Perform monitoring activities per the monitoring plan, including verification of source documents, informed consent review, site communications, and follow-up on data anomalies
- Review the accuracy and completeness of site records, including essential documents, query resolution, and other study documentation
- Ensure complete and accurate reporting and documentation of all monitoring activities
- Assist with site start-up activities, including developing PSV/SIV presentation materials and supporting the Regulatory and Site Contracting teams in the collection and review of regulatory documents
More about this role
Pedestal Health (formerly Target RWE) combines deep health system partnerships, longitudinal data curation at scale, and modern study design to build continuous, high-quality evidence for life sciences organizations. The company partners with pharmaceutical and biotech companies, providers and payers to generate rigorous, multimodal evidence that supports clinical, regulatory and strategic decision-making across the full lifecycle of care. Pedestal Health is committed to advancing medical decision making to improve outcomes for patients. Pedestal Health is a Highlander Health company. Learn more at pedestalhealth.com .
Pedestal Health is seeking a Senior Clinical Research Associate to conduct site management and data monitoring of assigned clinical sites, ensuring all activities are conducted in accordance with applicable Good Clinical Practices (GCP) and Standard Operating Procedures (SOPs). In addition to core monitoring responsibilities, the Senior CRA serves as a mentor to other CRAs and as a technical subject matter expert within the organization.
- Conduct remote site selection visits (PSVs) to evaluate whether facilities and staff are adequate for conducting the study.
-...
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