Sandra Abarca Email & Phone Number

Zug, Ch

Zug, Ch

site selection; site initiation; site close-out; site routine monitoring; CRF review and source data verification; sites and vendors communication; regulatory authorities communication; site management; visit reporting; S/AE processing and follow-up; feasibility support; client communication; training of site staff; training and mentoring of project team ensuring compliance with national regulations, GCP, protocol and procedures; EDC; audit preparation, participation and follow-up. Function as Lead CRATherapeutic Areas:INDICATION PHASE Hepatitis C II Breast Cancer II Diabetes Mellitus Type II II Melanoma III Breast Cancer III Diabetes Mellitus Type II III Stage IV Non-Small cell Lung Cancer Ib/II Castrate-resistant Prostate Cancer Ib/II Advance Epithelial Ovarian Cancer III Adenocarcinoma of the Lung III Intra-abdominal Infections IIIAdvance Carcinomas IMyelodysplastic syndrome III

clinical trials Management; investigator selection; analysis of potential patient recruitment; documentation preparation; committee submissions; investigator’s start-up and study site initiation meetings; laboratory samples and data coordination; patient optimization; site monitoring; SOP and GCP compliance; participate in global conference calls and meetings to review progress of ongoing clinical trials; CRF completion and tracking; database updating; query resolution; SAEs review; ensure Medical Director sign-off and site notification of compliance

Clinical Research AssociateDallas, TX, USAScope of responsibilities:human study subject protection; clinical data analysis and evaluation; ensure investigator and site compliance with the study drug protocol, overall clinical objectives, FDA regulations, ICH Guidelines, Good Clinical Practice (GCP) and HIPAA; site identification, selection, initiation and close out; site monitoring; protocol compliance; data reporting; data integrity, protection and verification; adverse event reporting; case report forms review and comparison to source documents

clinical site identification; offering clinical study participation; study management services; study contract and study budget negotiations; maintain working-relationship with the clinical sites; identify, prepare and train site personnel for CRO or study sponsor monitoring visits; protocol review; preparation of source document worksheets; customizing informed consent forms; preparation of local or central IRB submissions; Spanish language translation of study documents; maintenance of the regulatory documents; case report form (CRF) completion

scheduling appointments; maintaining medical records; billing, and coding for insurance purposes; taking and recording vital signs and medical histories; preparing patients for examination; drawing blood; administering medications as directed by physician

translation of documentation for IRB, ICF’s, Protocols, CRF’s and Diaries from English to SpanishDec2001–May2003

patient care; managing adults and children; patient assessments and interventions of acute and chronic disease; health maintenance; patient education; minor trauma/injuries; minor office procedures (toenail removal, foreign body removal, biopsies and excisions, simple laceration repair and management, routine fracture care)

cardiology and clinical skills program supervision for international medical students; medical students hand on trainingOct1998–Sep2001

Fellowship, Disorders In Metabolism Of Lipids, Obesity, Osteoporosis And Diabetes

Md/General Practitioner