Sofía Tartaglia Email & Phone Number

Sydney, New South Wales, Australia

Argentina

-Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.-Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.-Administer protocol and related study training to assigned sites and establish regular lines of communication… Show more -Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.-Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.-Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.-Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.-Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.-Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.-Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.-Collaborate and liaise with study team members for project execution support as appropriate.If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.-If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Show less

Argentina

-Complete appropriate therapeutic, protocol and clinical research training to perform job duties. -Gain experience in study procedures by working with experienced clinical staff. -Perform site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices. -Administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and… Show more -Complete appropriate therapeutic, protocol and clinical research training to perform job duties. -Gain experience in study procedures by working with experienced clinical staff. -Perform site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices. -Administer protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues. -Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. -Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution. Under close supervision may support start-up phase. -Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. Show less

Caba - Argentina

-Testing patient samples and interpreting the results for medical staff.-COVID-19 molecular diagnosis

Caba - Argentina

-Testing patient samples and interpreting the results for medical staff.-Carrying out complex analyzes on specimens of body fluids assuring the quality of clinical biochemistry investigations-Auditing the diagnostic and clinical use and performance of tests, often automated and computer assisted but sometimes requiring considerable manual expertise-Liaising with clinical and other healthcare staff, often in a multidisciplinary team setting-Patient contact

Caba - Argentina

-4 years program that provides in-depth training in all aspects of clinical biochemistry, which includes general clinical chemistry, toxicology, pediatric chemistry, immunology, endocrinology, microbiology, hematology, and molecular diagnosis-Conference presentation.-Resident teaching.-Participation in available research opportunities, publications and local and national presentations-COVID-19 detection.

Gran Buenos Aires, Argentina

-Performs clinical data management functions in support of clinical studies-Data review, protocol review, CRF review, data entry, database validation, query generation, and validation of study results-Assists with review, creation and/or updating of departmental documentation including but not limited to SOPs and training guidelines-Coordinates with clinical study personnel to provide timely feedback on data issues for resolution by investigational sites-Jointly with clinical… Show more -Performs clinical data management functions in support of clinical studies-Data review, protocol review, CRF review, data entry, database validation, query generation, and validation of study results-Assists with review, creation and/or updating of departmental documentation including but not limited to SOPs and training guidelines-Coordinates with clinical study personnel to provide timely feedback on data issues for resolution by investigational sites-Jointly with clinical study personnel, develops and prioritizes appropriate timelines for the completion of databases required for submission, report writing, and/or presentation purposes-Interacts with external laboratories in coordination with clinical study personnel to ensure that appropriate laboratory evaluations are being collected in accordance with protocol requirements and consistent with cGCP and/or approved SOPs Show less

Gran Buenos Aires, Argentina

-Responsible for detect, collect, monitor, research, assess and evaluate information of adverse events with pharmaceutical medications. -Revision of source documents.-Responsible for data entry, MedDRA coding and label assessment of adverse event. -Assess seriousness and causality.-Send the correct cases to the pertinent health authority of each country. -Follow up of queries with different countries. -Identify and analyze causes for the different queries and issues and… Show more -Responsible for detect, collect, monitor, research, assess and evaluate information of adverse events with pharmaceutical medications. -Revision of source documents.-Responsible for data entry, MedDRA coding and label assessment of adverse event. -Assess seriousness and causality.-Send the correct cases to the pertinent health authority of each country. -Follow up of queries with different countries. -Identify and analyze causes for the different queries and issues and suggest preventive and corrective actions. Show less

Gran Buenos Aires, Argentina

- Scanning, copying and maintenance of regulatory library.- Maintenance of databases and electronic regulatory library.- Drafting of monographs, assembly and collation of documents for records of Medical products.- Requests for documents to attend to affiliates.- Request for documents from affiliates for local registration.- Presentations at ANMAT and INAME; follow-up of procedures.- Support to the regulatory team

-Presentation of seminars and workshops to university-level students on topics in human physiology, including the cardiovascular, respiratory, renal, gastrointestinal, reproductive, endocrine, immunological, and neurological systems.-Basic research on the effect of different drugs on ischemic cardiovascular pathologies.-Carrying out the work under specific protocols.