Experience

Philadelphia University

• United States
• Higher Education
• 400 - 500 Employee

• • Feb 2020 - Present

  •Facilitating communication between site and Sponsors, Preparation, Submission, and Recollection of site study documents.•Responsible for managing general study procedures in the site and Regulatory process•Acknowledgment of electronic data capture and IVRS system, Handling of Dangerous Goods and Infectious Substances (IATA/ICAO), and GCP/ICH training.•Budget PI negotiation.•Site support throughout the study lifecycle from site identification through closeout or finish.•Knowledge of local requirements for real-world late phase study designs.•Chart activities and data collection.•As required, collaborate and build relationships with Sponsor and other affiliates, medical science staff, and local country staff.•Identify operational efficiencies and process improvements.•Develop country-level informed consent forms.•Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared..Submission all documents to ERB. Show less

• • Feb 2020 - Present

  Participant in phase II, III, and IV studies having the responsibilities of dispensing, reception, accountability, compliance, storage, relabeling process, and return of study medication and clinical supplies. In the share of delivery of local and central laboratory samples, local and central, reporting advance reports, protocol deviations, and serious adverse events to the EC/IRB and MOH compliance with study timelines.•Budget PI negotiation.•Site support throughout the study lifecycle from site identification through closeout or finish.•Knowledge of local requirements for real-world late phase study designs.•Chart activities and data collection.•As required, collaborate and build relationships with Sponsor and other affiliates, medical science staff, and local country staff.•Identify and communicate out of scope activities to Lead CRA/Project Manager.•Identify operational efficiencies and process improvements.•DeveLop country-level informed consent forms.•Collaborate with RWLP Regulatory team to ensure updated regulatory information is applied and shared.•Participate in bid defense meetings.•Written communication.•Supervisory Skills.•Computer skills.•Presentations skills.•Working knowledge of ICH/GCP regulations•Working knowledge of clinical protocols. Show less

• • Jan 2020 - Present

  •Facilitating communication between site and Sponsors, Preparation, Submission and Recollection of site study documents.•Responsible for managing general study procedures in the site and Regulatory process•Acknowledgment of electronic data capture and IVRS system, Handling of Dangerous Goods and Infectious Substances (IATA/ICAO), and GCP/ICH training.•During this time, I have been participating in site selection, site initiation, site monitoring, site audit and site close-out visits, and archiving process in the site.•Participant in phase II, III, and IV studies having the responsibilities of dispensing, reception, accountability, compliance, storage, relabeling process, and return of study medication and clinical supplies. In a share of delivery of local and central laboratory samples, local and central, reporting advance reports, protocol deviations, and serious adverse events to the EC/IRB and MOH compliance with study timelines.•Budget PI negotiation.•Site support throughout the study lifecycle from site identification through close out or finish.•Knowledge of local requirements for real-world late phase study designs.•Chart activities and data collection.•As required, collaborate and build relationships with Sponsor and other affiliates, medical science staff, and local country staff. Show less



Hospital Nacional Carlos Alberto Seguin Escobedo CASE/Centro Especializado de enfermedades Neoplasic

• Perú

• Study Coordinator

  • Jan 2019 - Present

  Oncology: Prostate Cancer - Phase III /2008-2009/ 05 Patients (Study Coordinator). Oncology: venous thromboembolism (VTE), in subjects with cancer, at high risk of suffering a VTE and in treatment with chemotherapy- Phase III/2008-2012/Forty-five patient (Study Coordinator). Oncology: Lung Cancer - Phase II - double-blind/ 2008-2012/ Four Patients. (Study Coordinator). Oncology: Prostate Cancer - Phase III - double-blind/2008-2012/05 Patients (Study Coordinator). Oncology: Breast Cancer - Phase III – Open-label/2010-2012/03 Patients (Study Coordinator). Oncology: Prostate Cancer - Phase III open-label/2010-2015/ 06 Patients (Study Coordinator). Oncology: Breast Cancer - Phase III – Open-label/ 2011-2014/05 Patients (Study Coordinator). Oncology: Prostate Cancer - Phase III double-blind/ 2010-2011/ 02 Patients (Study Coordinator). Oncology: Lung Cancer - Phase II - double-blind/2011-2015/Three Patients (Study Coordinator). Oncology: Prostate Cancer- PhaseIII double-blind/2011-2015.three patients (Study Coordinator) Oncology: Herpes Zoster in Patients with Solid Tumor or Hematologic Malignancy”- Phase III double-blind /2011-2017/ Sixty-five Patients (Study Coordinator). Internal Medicine: Urinary tract infection - Phase III double-blind /2012-2015/Five patients (Study Coordinator). Show less



Goyeneche Hospita

• Peru

• Certified Clinical Research Coordinator

  • Jan 2017 - Present

  Facilitating communication between site and Sponsors, Preparation, Submission, and Recollection of site study documents. •Responsible for managing general study procedures in the site and Regulatory process •Acknowledgment of electronic data capture and IVRS system, Handling of Dangerous Goods and Infectious Substances (IATA/ICAO), and GCP/ICH training. •During this time, I have been participating in site selection, site initiation, site monitoring, site audit, and site close-out visits, and archiving process in the site. •Participant in phase II, III, and IV studies having the responsibilities of dispensing, reception, accountability, compliance, storage, relabeling process, and return of study medication and clinical supplies. In the share of delivery of local and central laboratory samples, local and central, reporting advance reports, protocol deviations, and serious adverse events to the EC/IRB and MOH compliance with study timelines. •Budget PI negotiation. •Taking blood samples for evaluation in the central laboratory. •Processing of blood samples to be sent to the central laboratory to the environment and with dry ice. •Oral treatment to patients according to medical indications. •Application of quality of life questionnaires to patients. •Taking an electrocardiogram to patients according to medical indications. •Written communication. •Supervisory Skills. •Computer skills. •Presentations skills. •Working knowledge of ICH/GCP regulations •Working knowledge of clinical protocols •Study drug Dispensing, reception, accountability, accountability, and compliance, and re-labeling process. •Inspections Sponsor, ERB, CRO with good resolutions. •GCP training. •IATA procedures. •High study support with IVRS system, EDC, and query resolutions. •High study support with recruitments activities, management of EAs and SAEs, report of laboratory alerts. •Communication to ensure project activities with timelines meet. Show less



Specialized Centre for Neoplastic Diseases

• Peru

• Certified Clinical Research Coordinator

  • Jan 2015 - Present

  •Facilitating communication between site and Sponsors, Preparation, Submission, and Recollection of site study documents. •Responsible for managing general study procedures in the site and Regulatory process •Acknowledgment of electronic data capture and IVRS system, Handling of Dangerous Goods and Infectious Substances (IATA/ICAO), and GCP/ICH training. •During this time, I have been participating in site selection, site initiation, site monitoring, site audit, and site close-out visits, and archiving process in the site. •Participant in phase II, III, and IV studies having the responsibilities of dispensing, reception, accountability, compliance, storage, relabeling process, and return of study medication and clinical supplies. In the share of delivery of local and central laboratory samples, local and central, reporting advance reports, protocol deviations, and serious adverse events to the EC/IRB and MOH compliance with study timelines. •Budget PI negotiation. •Taking blood samples for evaluation in the central laboratory. •Processing of blood samples to be sent to the central laboratory to the environment and with dry ice. •Oral treatment to patients according to medical indications. •Application of quality of life questionnaires to patients. •Taking an electrocardiogram to patients according to medical indications. •Written communication. •Supervisory Skills. •Computer skills. •Presentations skills. •Working knowledge of ICH/GCP regulations •Working knowledge of clinical protocols •Study drug Dispensing, reception, accountability, accountability, and compliance, and re-labeling process. •Inspections Sponsor, ERB, CRO with good resolutions. •GCP training. •IATA procedures. •High study support with IVRS system, EDC, and query resolutions. •High study support with recruitments activities, management of EAs and SAEs, report of laboratory alerts. •Communication to ensure project activities with timelines meet. Show less



Specialized Centre for Neoplastic Diseases CEEN

• Perú

• Clinical Research Coordinator

  • Jan 2015 - Present

  • Oncology: Breast Cancer Triple-negative - Phase III – Open-Label/ 2019 – To present/One Patients. Study Coordinator. • Oncology: Non-Small Cell Lung Cancer - Phase III – Double-blind/2018- 2020 Three patients. Study Coordinator. • Oncology: Non-Small Cell Lung Cancer - Phase III – Double-blind/2019- to present / Six patients.Study Coordinator. • Oncology: Breast Cancer - Phase III – Double-blind/2018 – 2020 Eight Patients.Study Coordinator. • Oncology: Breast Cancer - Phase III – Double-blind/ 2019 – To present/Two. Patients.Study Coordinator Show less



Hospital Carlos Alberto seguin Escobedo ESSALUD.

• Esquina Peral y Ayacucho S/N Cercado Arequipa - PERU

• Obstetrician/Clinical Research Study Coordinator

  • Jan 2008 - Present