Clinical Operations Assistant
Reports to Biomarker Operations Manager
The clinical operations assistant will assist the Biomarker Operations Manager and Quality in supporting the technical and logistics associated with clinical sample collection and drug supply in multi-center oncology clinical trials. They will coordinate collection, shipping, and perform initial processing of clinical samples, maintain an accurate database and perform basic statistical analysis. They will work with Quality to track inventory of drug product and its timely supply to clinical sites in often complex multi-center studies in oncology. The ideal candidate is a team-player who is detail-oriented and able to successfully multi-task in a fast-paced environment.
- Assist in coordinating operational activities required to manage the lifecycle of clinical trial samples including collection, shipping, processing, analysis, data reporting and final sample disposition or storage.
- Communicate effectively with central labs, external vendors engaged in sample analysis to ensure consistent execution of biomarker processing, analysis, and data delivery.
- Manages inventory of various drug products, and arranges shipping and ensures timely delivery to multi-centers
- Provides the day-to-day operational management of biomarker vendors to ensure delivery against contracted scope of work
- Manage with supervision results provided by third-party vendors (e.g., edit checks, quality acceptance; reconciles external data against the clinical data; resolves data discrepancies between the external data and the clinical data)
- Develops and maintains effective working relationships with study teams, particularly with clinical research associates, CRO & central lab, external labs and collaborators.
- Assist in the management and statistical analysis of correlative and biomarker data from clinical trials and helps maintain current biomarker data summaries.
- Track, resolve and appropriately escalate issues to supervisor related to sample and/or data quality (verifies completeness, consistency, and integrity of biomarker data following review of results).
- Works with supervisor to provide clinical biomarker operations expertise to ensure operational feasibility and delivery
- Works with supervisor to identifies areas of best practice and process improvements
- Ensures study and biomarker operational adherence to ICH/GCP and SOPs
- Life sciences degree (Bachelor or Masters) in Scientific, Medical or Healthcare subject area required.
Experience and Skill Requirements
- Strong experience in a clinical research setting, clinical/diagnostic laboratory, or biotech R&D environment