Biosample Operations Specialist / Acting Manager
The Biosample Operations Specialist is an organized and detail-oriented candidate who coordinates all operational activities required for the collection, shipment, and delivery of biosamples at Caprion. Reporting to the Biosample Operations Manager, the Biosample Operations Specialist serves as the point of contact for study teams (including CRO/clinical sites) for biosample operational questions and issues at the study level. The Biosample Operations Manager assists the ImmuneCarta and ProteoCarta teams for the procurement of biological samples from different suppliers and possesses sufficient knowledge of ethics to ensure the procurement and use of human biological samples in accordance to current regulations.
- Organizes and helps drive decisions on sample collection, logistics and shipping schedule before study initiation and during the study;
- Coordinate clinical sites, couriers and clients to organize, monitor and ensure the delivery of study samples or study reagents in a timely manner;
- Checks that clinical sites and/or CRO send samples according to agreed stability shipping schedule and takes corrective action where this is not the case;
- Responsible for ensuring that sample collection information is adequate for effective sample tracking and reconciliation;
- Serves as the main point of contact for sample procurement of future and current studies at Caprion;
- Responsible for clinical site evaluation, and laboratory manual writing;
- Trains the clinical sites on the laboratory manual (blood processing and sample shipment);
- Maintains professional knowledge of current ICH, GCP, GLP, GCLP, biobanking, sample management policies, best practices and ethical guidelines, and applies knowledge appropriately;
- Files, tracks and reviews all related documentation in a timely manner.
- B.Sc. or M.Sc. in life sciences, preferably in immunology, biology or biochemistry.
Knowledge and Skills:
- Experience in working in clinical studies at a clinical site or proven clinical/biological laboratory experience with evidence of involvement in the processing of biological samples;
- Experience in laboratory manual writing;
- Knowledge and understanding of GDP, and GLP, GCLP, and ICH regulations; knowledge of procedures and protocols for containment of biohazardous material; ability to understand safety procedures and guidelines;
- Knowledge of blood sample processing and cell cryopreservation techniques, and cell culture techniques;
- Knowledge of informed consent process and ethics guidelines;
- Proven effective communication skills, in both English and French;
- Good organizational and influencing skills;
- Rigorous, autonomous and detailed-oriented in the conduct of his/her work;
- Critical reasoning skills including the identification and resolution of complex problems;
- Experience in working in a GLP/GCLP environment;
- Very good knowledge of Microsoft Excel and Microsoft Word, and experience working with a LIMS;
- Available to adapt his/her schedule to accommodate business needs.
Interested candidates should send their résumé by email to firstname.lastname@example.org