Claudia Ximena Asela Pinzón
Clinical Study Coordinator at Clínica Universitaria Bolivariana- Claim this Profile
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Inglés -
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Francés Elementary proficiency
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Español Native or bilingual proficiency
Topline Score
Bio
Credentials
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Good Clinical Practices and Colombian Regulation in research based on ICH E6 GCP (R2)
Universidad Pontificia BolivarianaMay, 2022- Oct, 2024
Experience
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Clínica Universitaria Bolivariana
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Colombia
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Medical Practices
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1 - 100 Employee
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Clinical Study Coordinator
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Jul 2018 - Present
Compliance with good clinical practices and ethical principles of human research. Extensive knowledge and management of data entry platforms such as: Inform, iMedidata, Trialmax, Bioclinica. Collected data and followed research protocols, operations manuals and case report form requirements. Collected, evaluated and modeled collected data. Created spreadsheets using Microsoft Excel for daily, weekly and monthly reporting. Manage the research center's own procedures, ensuring compliance with management indicators and regulations. To liaise with the CRO and sponsors in order to follow the guidelines defined for each of the protocols. Plan, verify and follow up on research protocol activities. Articulate the different units of the research center, such as: principal investigator, sub-investigator, pharmaceutical service, clinical laboratory, ethics committee. Conduct and submit follow-up reports on clinical trials. Provide support in training and capacity building processes for the personnel in charge. Facilitate co-evaluation of the feasibility of a clinical trial. Show less
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Clinical Study Coordinator
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Apr 2016 - Jul 2018
Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols. Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets. Monitored unit budget to meet financial objectives for spend rate and funding. Onboarded new temps by entering employee information into systems. Led projects and analyzed data to identify opportunities for improvement. To be in charge of all timely communication with the ethics committee. Perform protocol safety component reporting (serious and non-serious adverse events) required by regulatory authorities. Custody of documentation and products related to the test. Review and ensure that all tests are performed when applicable according to protocol. Ensure that the protocol is executed according to the established timelines. Carry out recruitment strategies for study participants. Carry out field trips programmed by the institution. Conduct training when required within the scope of the project or others. Develop plans and programs for research and innovation projects taking into account institutional guidelines. Show less
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Universidad de Antioquia
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Higher Education
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1 - 100 Employee
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Research associate professional
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Apr 2016 - Nov 2016
"Construction of a pharmacological network based on pharmacodynamic and pharmacokinetic simulations in sillico for the rational selection of drugs with leishmanicidal activity". To evaluate the in vitro antileishmanial activity of the selected compounds by pharmacokinetic and pharmacodynamic simulations. Deliver periodic reports of the analyses performed and results obtained. "Construction of a pharmacological network based on pharmacodynamic and pharmacokinetic simulations in sillico for the rational selection of drugs with leishmanicidal activity". To evaluate the in vitro antileishmanial activity of the selected compounds by pharmacokinetic and pharmacodynamic simulations. Deliver periodic reports of the analyses performed and results obtained.
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Fundación Universidad de Antioquia
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Colombia
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Civic and Social Organizations
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1 - 100 Employee
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Clinical Study Coordinator
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Apr 2013 - Mar 2016
Maintained compliance with protocols covering patient care and clinical trial operations. Coordinated clinical trials focused on disorders such as leishmaniasis and vaccines for dengue. Screened patient records, databases and physician referrals to identify prospective candidates for research studies. Gathered, processed and shipped lab specimens. Used coordination and planning skills to achieve results according to schedule. Maintained compliance with protocols covering patient care and clinical trial operations. Coordinated clinical trials focused on disorders such as leishmaniasis and vaccines for dengue. Screened patient records, databases and physician referrals to identify prospective candidates for research studies. Gathered, processed and shipped lab specimens. Used coordination and planning skills to achieve results according to schedule.
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Professor of Cell Biology
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Sep 2015 - Dec 2015
Preparation of theoretical and laboratory classes in cell biology. Conducting periodic evaluations to students. Preparation of theoretical and laboratory classes in cell biology. Conducting periodic evaluations to students.
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Professor of Cell Biology
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May 2015 - Jun 2015
Preparation of theoretical and laboratory classes in cell biology. Conducting periodic evaluations to students. Preparation of theoretical and laboratory classes in cell biology. Conducting periodic evaluations to students.
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PECET
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Research Services
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1 - 100 Employee
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Clinical Study Coordinator
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Feb 2010 - Dec 2013
Collected data and followed research protocols, operations manuals and case report form requirements.Worked to maintain outstanding attendance record, consistently arriving to work ready to start immediately.Proved successful working within tight deadlines and fast-paced atmosphere.Maintained compliance with protocols covering patient care and clinical trial operations.Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.Followed informed consent processes and maintained records. Show less
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Research Associate
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Feb 2010 - Apr 2013
Development of the project: "Evaluation of the therapeutic response and toxicity of a new topical formulation of Amphotericin B as a therapeutic alternative for Cutaneous Leishmaniasis".
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Bacteriologist
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Dec 2011 - Mar 2012
Bacteriologist of the project Molecular and biochemical characterization of choline and ethanolamine kinases of Leishmania sp as a new therapeutic target for the treatment of leishmaniasis.
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Young researcher COLCIENCIAS
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Apr 2012 - Mar 2013
Development of the project: "Evaluation of the leishmanicidal activity of amphotericin B in the golden hamster animal model". Development of the project: "Evaluation of the leishmanicidal activity of amphotericin B in the golden hamster animal model".
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University professor
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Aug 2011 - Nov 2011
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University professor
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Aug 2010 - Nov 2011
Edelfosine clinical trials and Leishmaniasis patient database
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University professor
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Feb 2011 - Jun 2011
Edelfosine clinical trials and Leishmaniasis patient database
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Education
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2010 - 2013
Universidad de Antioquia
Master of Sciences, Basic Biomedical Sciences, emphasis in Tropical Medicine, Basic Biomedical Sciences -
2009 - 2010
Universidad Industrial de Santander
Diploma Public Health, Management of the Public Health Plan of Collective Interventions, Public Health -
2004 - 2008
Universidad Industrial de Santander
Bacteriologist and clinical laboratorist, Medical microbiology and bacteriology
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