Claudia Negrón Email & Phone Number

Montreal, Quebec, Canada

● Set up, maintained, and closed out project files and study information (KPIs, regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), protocol deviations, site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems.● Recorded the status of Key Performance Indicators (KPIs) in assigned systems, with input and oversight from PL, and proposed action plans.● Led internal and sponsor… Show more ● Set up, maintained, and closed out project files and study information (KPIs, regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), protocol deviations, site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems.● Recorded the status of Key Performance Indicators (KPIs) in assigned systems, with input and oversight from PL, and proposed action plans.● Led internal and sponsor (external) meetings and followed up with team members on action items.● Prepared and provided status reports to clients.● Served as project representative for internal and external audits. Provided support for quality assurance activities, including preparation for audits and internal review, preparing documentation, and resolving actionable issues. ● Ensured that clinical trials were conducted in accordance with GCP Guidelines, SOPs, and international/local regulations.● Ensured all study documents were archived based on the appropriate guidelines and policy. ● Served as the primary customer contact when PL was out of the office. Sought input from Project Director for customer support. Show less

● Ensured that clinical trials were conducted in accordance with GCP Guidelines, SOPs, and international/local regulations.● Reviewed and filed regulatory documents for proper content.● Performed eTMF file reviews and provided eTMF status reports according to SOPs and GDP.● Participated in Site Evaluation Visits (PSVs), Investigator Meetings (IMs), and Site Initiation Visits (SIVs)● Communicated with sites regarding trial start-up, conduct, and close-out administrative and… Show more ● Ensured that clinical trials were conducted in accordance with GCP Guidelines, SOPs, and international/local regulations.● Reviewed and filed regulatory documents for proper content.● Performed eTMF file reviews and provided eTMF status reports according to SOPs and GDP.● Participated in Site Evaluation Visits (PSVs), Investigator Meetings (IMs), and Site Initiation Visits (SIVs)● Communicated with sites regarding trial start-up, conduct, and close-out administrative and logistical activities.● Identified potential investigators and developed initial protocol packets. ● Reviewed the IRT (Interactive Response Technology) inventory, generated reports in SmartSupplies (company-owned depots and sponsor-owned depots), supported ePIF submissions, and created shipment request forms, VTAFs, and temperature excursion forms. ● Liaised with sites to resolve identified issues. ● Supported monitors with the day-to-day administration of clinical studies. Show less

● Reviewed regulatory documents for proper content.● Maintained internal and sponsor-owned Public Folders/ePOI/S drive in accordance with SOPs and GDP.● Maintained Trial Master File according to SOPs and GDP.● Performed file reviews and logging of quality issues in project-related tracking tools.● Disseminated study-related information, including project tracking updates to clinical study teams, clients, and other departments.

● Prepared and distributed Investigator Site Files (ISFs), Pharmacy Site Files (PSFs) needed for Site Initiation Visits (SIVs). ● Prepared and maintained the Trial Master File (CMF and IFs) according to Pharm-Olam SOPs or Sponsor SOPs within project timelines● Prepared Essential Document Packages (EDP).● Performed translations and back-translations of study documentation● Communicated with sites regarding trial start-up, conduct, and close-out of administrative and logistical… Show more ● Prepared and distributed Investigator Site Files (ISFs), Pharmacy Site Files (PSFs) needed for Site Initiation Visits (SIVs). ● Prepared and maintained the Trial Master File (CMF and IFs) according to Pharm-Olam SOPs or Sponsor SOPs within project timelines● Prepared Essential Document Packages (EDP).● Performed translations and back-translations of study documentation● Communicated with sites regarding trial start-up, conduct, and close-out of administrative and logistical activities.● Participated in feasibility and/or site identification activities.● Reviewed study files periodically for accuracy and completeness.● Prepared and maintained QC/Inventory Checklists for the TMF (CMF and IFs) and ISFs.● Maintained Public Folders/ePOI/S drive in accordance with the Filing Plan.● Prepared and maintained country and site-related study trackers● Provided continuous support to CRAs with the day-to-day administration of clinical studies. Show less

● ICH GCP E6 R (2) guidelines.● FDA Regulations 21CFR 11, 50, 54, 56 and the Common Rule 45CFR46.● Data Management.● Informed Consent Process● Clinical Trial Operations from feasibility through close-out.● GDP following ALCOA-C principles.● Recruitment and retention of participants to clinical trials.● Identification and reporting of AEs and SAEs.● Quality Assurance, Monitoring, and Query Resolution● Comprehension and Execution of Clinical Trial… Show more ● ICH GCP E6 R (2) guidelines.● FDA Regulations 21CFR 11, 50, 54, 56 and the Common Rule 45CFR46.● Data Management.● Informed Consent Process● Clinical Trial Operations from feasibility through close-out.● GDP following ALCOA-C principles.● Recruitment and retention of participants to clinical trials.● Identification and reporting of AEs and SAEs.● Quality Assurance, Monitoring, and Query Resolution● Comprehension and Execution of Clinical Trial Protocols.● Maintaining a regulatory binder, housing essential documents including but not limited to 1572, DOA, Training Logs, and other Investigator Site File (ISF) documents. Show less

Mexico City, Mexico

● Protein synthesis in cancer research.● Experimental design.● Gained great experience in grant writing.● Conducted research conferences and preventive medicine talks to broad audiences.

● Created new products and improved existing ones.● Became an inventor of a patent in the biotechnology sector.● Drafted and filed patent applications for new products● Ensured compliance of products with regulatory agencies.

● Lead and managed projects to ensure completion and success. ● Promoted data-driven solutions and implemented small- and large-scale changes to reduce waste and time of production. ● Lead data collection and conducted the validation of the measurement system.

● Evaluated, documented, and carried out all activities related to AEs and SAEs and safety information in compliance with all applicable regulations. ● Conducted theoretical research for diabetes projects. ● Provided orientation about treatments to patients. ● Promoted the company’s drugs to medical healthcare professionals. ● Organized webinars for public and private health organizations

Doctor Of Philosophy - Phd, Human/Medical Genetics

Cancer genetics research

Bachelor Of Science In Biotechnology Engineering (Concentration In Molecular Biology)

Master Of Science (Specialty In Molecular Biology And Genetics), Molecular Biology And Genetics