Clinical Research Associate

• Jan 2022 - Present

Clinical Research Associate

• Dec 2019 - Jan 2022

The responsibility of a Clinical Research Associate (CRA) is to perform in site and/or remote clinical monitoring tasks for designated projects in accordance with ICH-GCP guidelines, relevant SOPs and regulations. Responsibilities include: • Collect regulatory documentation (prepare the required study documents for the initial study applications to Ethics Committees and Competent Authority- Israeli Ministry of Health, prepare and compile Site Regulatory Packages). • Perform clinical monitoring activities (assure the presence of all relevant documents on site, collection / source data verification of Case Report Forms, drug accountability, report visits and contacts with site). • Extensive site contact and site support on a regular basis, observe and support recruitment, report the progress of the study on a regular basis. Show less

Clinical Study Coordinator

• Apr 2016 - Dec 2019

• Management of the coordination and hospital records for the execution of the different researches in the department. • Identification of eligible patients (assessment of inclusion/exclusion criteria, examine medical files according to research protocols). • Approach and invite potential subjects to participate in the trial, provide information and explanations; obtain an informed consent.Collaboration with the Principle Investigator & staff. • Follow up on subjects procedures: schedules, vital signs examinations (ECG, weight, blood pressure etc.); Study drug use and subjects reaction to experimental treatment. • Provide service and answer to patients, responsible for the connection to labs and pharmacies. • Full documentation (CRF), according to the research protocols; medical history, follow up and research progress. • Medication management, temperature control and storage conditions according to the protocol and GCP requirement. • Research closure management: collect and gather all data and excess drugs and equipments. Show less

Laboratory Assistant

• Feb 2014 - Sep 2015

• Biochemistry lab that Specialized in crystallography. • Experienced in advanced analytical equipment (FPLC, PCR, and more). • Knowledgeable in Microbiology and Molecular techniques. • Knowledgeable in Protein purification methods. • Biochemistry lab that Specialized in crystallography. • Experienced in advanced analytical equipment (FPLC, PCR, and more). • Knowledgeable in Microbiology and Molecular techniques. • Knowledgeable in Protein purification methods.