Martha Eugenia Hernandez Leon
Clinical Research Coordinator at Population Health Research Institute- Claim this Profile
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Spanish Native or bilingual proficiency
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English Full professional proficiency
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French Elementary proficiency
Topline Score
Bio
Credentials
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Health Canada Division 5 - Drugs For Clinical Trials Involving Human Subjects - Student/Trainee
CITI ProgramJul, 2022- Nov, 2024 -
CRC / ACRP Certification.
Association of Clinical Research ProfessionalsOct, 2014- Nov, 2024
Experience
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PHRI Population Health Research Institute
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Canada
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Research Services
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200 - 300 Employee
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Clinical Research Coordinator
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Nov 2015 - Present
My responsibilities include overseeing the collection, entry, verification, management, tracking, and reporting of data and other documents related to study management.Create data collection forms, error checking methods and related programmes for efficient collection, analysis and reporting; troubleshoot computer problems; prepare required study documentation/updated and other required tool for the project; liaise with study centre personnel, study committee members and other related study personnel; ensure relevant clinical and research methodology is applied, and proper handling of all clinical research material is used; train and supervise data clerks and other study staff in the processing of study data (i.e. data entry); assist with preparations of scientific papers, abstracts and graphs; perform literature searches. Show less
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Quality Assurance Coordinator
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Jul 2019 - Present
To conduct quality assurance activities such as auditing, Standard Operating Procedures (SOP) review and management, Corrective Action/Preventive Action (CAPA) and regulatory training. To provide Quality Assurance and regulatory advice to the Population Health Research Institute (PHRI) organization.
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SE Health
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Canada
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Hospitals and Health Care
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700 & Above Employee
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Personal Support Worker
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Jun 2014 - Nov 2015
• Assist clients in the activities of personal care, household management and generalized services as per the client care plan and in conjunction with Saint Elizabeth Health Care’s policies and procedures. • Assist clients in the activities of personal care, household management and generalized services as per the client care plan and in conjunction with Saint Elizabeth Health Care’s policies and procedures.
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University Health Network
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Canada
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Hospitals and Health Care
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700 & Above Employee
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Clinical Research Data Regulatory Coordinator.
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Nov 2013 - Feb 2014
• Participated in the coordination of clinical trials from protocol review and approval through to activation, follow up and trial closure. • Monitoring and promoting the quality and integrity of data and recording clinical trial data in Case Report Forms (CRF’s). • Recording clinical trial data in Case Report Forms (CRF’s) and answering queries. • Participated in the coordination of clinical trials from protocol review and approval through to activation, follow up and trial closure. • Monitoring and promoting the quality and integrity of data and recording clinical trial data in Case Report Forms (CRF’s). • Recording clinical trial data in Case Report Forms (CRF’s) and answering queries.
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Centre universitaire de santé McGill | McGill University Health Centre
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Canada
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Hospitals and Health Care
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700 & Above Employee
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Volunteer CanSupport Program.
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Aug 2012 - Jun 2013
•Greet newly diagnosed patients and their families and inform them about CanSupport, MUHC (McGill University Health Centre) and community resources.•Engage in supportive conversation and active listening.•Organize and lend books, CDs and DVDs.•Organize and serve in-patients, families and staff.
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Volunteer Arts and Crafts program.
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Oct 2012 - Dec 2012
Job Duties:• Demonstrate to patients how to do arts and crafts projects and assist them if needed.• Visit patients on a one-on-one basis as suggested by the nurse in charge and deliver arts and crafts materials.• Do friendly visit activities with the patients.• Offer or provide the patients some magazines, crosswords and books.
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Latam Clinical Trials
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Colombia
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Pharmaceutical Manufacturing
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Clinical Research Associate (CRA)
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Nov 2010 - Feb 2012
Job Duties: • Conducted and scheduled Pre-Study Selection Visits (PSSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV) and Close Out Visits (COV) in accordance with the monitoring plan requirements. • Communication link between the sponsor and site during the course of monitoring at site visits. • Oversaw clinical trials according to local and ICH-GCP regulations. • Obtained documentation required for local IRB and agency submission and verify that required documentation has been sent to/approved by local agency. • Trained site staff on critical elements (Protocol deviations, study procedures, Data Clarifications Forms (DCFs), amendments etc.) • Made an interpretative judgment about the quality of the site. • Maintained all required documents to ensure they are properly filed at site and sponsor. • Reviewed of Case Report Forms (eCRFs) and Sources Document Verification (SDV). • Attended local and international meetings as needed. Accomplishments: - Commended by Project Director and Project Manager on numerous occasions for the quality of my performance (good quality of the IMR reports letters, accuracy of data reviewed from the CRF and good recruitment the patients for the clinical trial). - Promoted to CRA Regular and increased on my wage after of three months of starting the job. - Established good working relationships with Principal Investigators/Study Coordinators. Show less
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Fundacion Oftalmologica Nacional (Fundonal)
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Bogota-Colombia.
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Clinical Research Coordinator (CRC).
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Feb 2007 - Mar 2010
Job duties: •Coordinated clinical trials phase II and III in ophthalmology accordance with protocol, local and ICH-GCP regulations. • Completed Case Report Forms (CRFs) and documented adverse events. • Maintained source-documentation and drug/device accountability. • Attended local and international meetings as needed. • Participated in site recruitment activities. • Attended Pre-Study Selection Visits (PSSV), Site Initiation Visits (SIV), Interim Monitoring Visits (IMV) and Close Out Visits (COV) meetings when requested. • Participated in consent process. Accomplishments: - Received good recognition by the Clinical Research Associates for the compliance with the clinical trial protocol and the quality of my performance. Show less
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Registered Nurse (RN).
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Sep 2004 - Feb 2007
Job duties: • To take patients’ pulse, blood pressure and temperature, ECGs, samples and also observe and record the condition of patients. • To ensure that care plans are implemented and evaluated on a regular basis for every patient. • To carry out care procedures, such as wound healings, administering medication, injections and intravenous infusions. • To communicate in a caring manner with patients and their family members. • To be involved in the administration procedures for patients’ admission and also their discharge. • To carry out administrative duties like updating and maintaining patient records. • To participate in nursing team meetings. Show less
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Fundacion Santa Fe de Bogota
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Colombia
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Hospitals and Health Care
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700 & Above Employee
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Registered Nurse (RN).
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Mar 1999 - Mar 2004
Job Duties: • To take a patients pulse, blood pressure and temperature, ECGs, samples and also observing and recording the condition of patients. • To ensure that care plans are implemented and evaluated on a regular basis for every patient. • To carry out care procedures, such as wound healings, administering medication, injections and intravenous infusions. • To communicate in a caring manner with patients and their family members. • To be involved in the administration procedures for a patient’s admission and also their discharge. • To carry out administrative duties like updating and maintaining patient records. • To participate in nursing team meetings. Show less
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Education
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2014 - 2015
McMaster University
Certified Clinical Research Associate (CCRA), Health/Health Care Administration/Management -
2013 - 2013
Niagara College Canada
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2012 - 2012
McGill University - Macdonald Campus
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1993 - 1997
Universidad de La Sabana
Bachelor's degree, Registered Nursing/Registered Nurse -
La Presentacion
Elementary and High school.
Community
