Clinical Studies Specialist - Randstad : Job Details

Performs key operational activities across the Clinical Documentation Center for master files through life cycle. Collaborates with Master File Owners to support inspection readiness of clinical documentation / master files; may be aligned by Therapeutic Area but expected to work across all areas of the organization. location: Telecommute job type: Contract salary: $26 - 30 per hour work hours: 9 to 5 education: Bachelors res[ \r\n\t. Applies critical thinking to ensure real-time inspection readiness of clinical documentation by: - investigates and proactively resolved issues - runs and performs review of reports and dashboards within e. TMF - produces e. TMF metrics - communicates to Master File owner(s) root cause analysis and potential data integrity concerns\r\n\t. Leads to completion of the final reconciliation/review and archival of individual master files, working closely with the Clinical Documentation Associate (CDA), CDC leadership and other TMF stakeholders (i.e., CPD, SM&M...Clinical, Specialist, Clinical Research, Auditor, Healthcare, Staffing, Inspection