Blanca Linares-Rivas Rico

The role of a GOSM is equivalent of that of a Lead CRA. Reporting directly to the Study Leaders my duty is to provide an update of the trial status and the escalation of any issues which would jeopardize quality or timelines. During trial start up I am responsible of defining how the monitoring duties will be conducted ensuring compliance with the Protocol, our SOPs and ICH GCP. During trial conduct I support and oversee Local teams and ensure corrective actions are taken if our expectations are not met.

As a CRA at Headquarters, I am involved in different trials worlwide. My work inhouse is mainly to ensure that the vendors (CROs, IRT, eCRF providers) fulfill the company's needs, ease the trial conduct, while complying with ICH GCP. I also have field based duties such as co-monitoring to assess that the trial conduct at site level meets our standards. If any issue or opportunity for improvement are identified, my duty is to design and implement corrective actions.

Starting as a RA (Research assictant) giving in-house support to CRAs and going to sites for co-monitoring visits. As a CRA I was allocated to different projects and performed on-site monitoring visits. Therapeutic areas in which I worked in: Infectious diseases, respiratory illnesses, oncology and cardiovascular diseases.

Master Thesis in the Quality Assurance Department