December 16th 2020
Founded in 2000, Caprion partners with the largest pharmaceutical and most prominent biotech companies. In 2019, under the leadership of the leading specialized private equity firm Arsenal Capital Partners, Caprion joined forces with HistoGeneX, creating an integrated leader in precision medicine and biomarker development. The combined businesses partner with the pharmaceutical industry to accelerate precision medicine, supporting the entire drug development cycle, from preclinical through late stage clinical trials and companion diagnostics.
Key Responsibilities
• Communicates with clinical sites, couriers and clients to track the delivery of study samples or study reagents on a daily basis;
• Verifies that sample collection information is adequate for effective sample tracking and reconciliation;
• Investigates and addresses discrepancies;
• Ensures issues are resolved or escalated in a timely manner;
• Tracks, reviews and updates the sample databases in a timely manner;
• Organizes international shipments as per IATA regulations to and from Caprion laboratory using the appropriate documentation;
• Participates in the writing and reviewing of Laboratory Manuals for clinical sites;
• Assists the operational staff for the procurement of biological samples from different suppliers;
• Assists the operational staff for the reception of biological samples;
• Ensures all work is compliant with appropriate SOPs and all applicable regulatory requirements;
• Defines and monitors Key Performance Indicators (KPI);
• Participates in the writing and reviewing of SOPs and associated worksheets/forms;
• Applies Good Documentation Practices (GDP);
• Ensures all work is compliant with appropriate SOPs and all applicable regulatory requirements;
• Supervises and performs all biobanking-related activities (sample ordering, reception, documentation, tracking and inventory) in compliance with applicable procedures and according to the regulatory requirements.
Other Responsibilities
• Performs other duties as assigned.
Special Conditions of the Current Position
• Must accept to perform duties or supervise activities in Bio Safety Level (BSL) 1 or 2 facilities where biological samples may be either naturally or experimentally infected with potentially hazardous virus such as HIV, HCV, or CMV;
• Employee is personally responsible for following Health and Safety guidelines/instructions.
• This position can involve evening and/or week-end work.
Education
Experience
Knowledge Requirements
Skill Requirements
For more informations please contact to Caprion
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