· CNS: ph.iii & iv epilepsy; post-market f-up deep brain stimulation therapy for obsessive-compulsive disorder; ph.iv renal denervation.
· infectious: ph.iii childrens´ skin infection; ph.iv invasive fungic disease
· pediatric study. study sponsored by a Physician in egg allergic children.
tasks performed as CRA: feasibilities, Qualification/initiation/monitoring and close-out visits in accordance to gcp/ich, local regulations and company sops. Data Management (queries resolution), central file maintenance, relabeling, appropriate reporting and follow-up for all safety events by site personnel. audits preparation, liaising with vendors ( supplies/ivrs/imaging/ drug).
Ø Clinical Trial assistant (cta), parexel international, madrid. oct. 2001-nov 2002. tasks performed: assisting cras in their functions: preparation of monitoring visits, coordinating the timely shipment of clinical supplies and study drug to each investigational site as required, assisting the cras in ensuring that central files are well maintained, complete and up-to-date, assisting cras with on site monitoring (crfs review, drug reconciliation & accountability, handling queries and rest of study data). management of sites´contracts and payment process in collaboration with financial department.
Ø Clinical Research Associate (fellow in practice), quintiles, madrid. oct 2000-feb 2001. tasks performed: supporting the cras with feasibility studies and Qualification visits, teleconferences attendance, patients status spreadsheet tracking and central file maintenance.
Ø Therapeutic Areas worked:
- CNS: ph.iii & iv epilepsy; post-market f-up deep brain stimulation therapy for obsessive-compulsive disorder; ph.iv renal denervation.
- urology: post-market, erectile dysfunction
- Rheumatology: ph.iii rheumatoid arthritis
- infectious: ph. iii Hospital acquired pneumonia, ph.iii childrens´ skin infection; ph.iv invasive fungic disease
Ø evidence based pharmacotherapy on-line course. institution: agora farmaceutica. Pharmaceutical official colleges of madrid & barcelona. (28march 2011-5 june 2011).
Ø ongoing advanced Training courses gcps launch & learn sessions. Therapeutic Areas (aids,cardiovascular, crm, oncology), cross cultural management, CRA role refresh Training courses, local regulatory issues, government regulatory inspections, Databases ( impact,cims, inform).
Ø languages: fluent in English ( spoken, written). spanish (mother). 9 months stay abroad (ireland, usa).
Ø computer skills: office user. electronic crfs used :phase forward- inform, accovion. Databases: lotus notes, impact, medidata rave.
- excellent oral and written Communication Skills
- excellent Planning and organization skills with effective Time Management
- excellent interpersonal skills, used to work in a team environment
- ability to work ethically, motivation for own professional development, proactive, results-oriented and customer-oriented.