Position Summary:
The QC Specialist is responsible for ensuring the accuracy, completeness, and compliance of clinical trial documentation and data across all research sites. This role performs ongoing quality checks of source documents, regulatory files, and study data to maintain audit readiness and adherence to protocol, GCP, and sponsor requirements.
Key Responsibilities:
Perform routine QC reviews of:Source documentsInformed consent forms (ICFs)Regulatory binders / eISFEDC entries vs source (SDV support)Identify and flag:Missing documentationData discrepanciesProtocol deviationsGCP compliance gapsEnsure all documentation meets:ALCOA+ principlesSponsor and protocol requirementsFDA / ICH-GCP standardsTrack and follow up on QC findings until resolutionSupport audit and inspection readiness across all sitesWork closely with:Study coordinatorsInvestigatorsRegulatory teamAssist with:CAPA development and implementationSOP adherence and training reinforcementKey Skills:
Strong attention to detailAnalytical and problem-solving skillsAbility to identify trends and recurring issuesOrganized and able to manage multiple studies/sitesStrong communication and follow-up
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We are seeking a highly qualified Oncology Physician (MD) to join our growing clinical team. The ideal candidate will have experience in oncology care and a strong interest in clinical research. Responsibilities include patient evaluation, treatment oversight, and participation in oncology clinical trials. Candidates must hold an active medical license and demonstrate excellent communication and patient care skills. Join a dynamic, fast-growing research organization committed to advancing innovative cancer treatments.
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