Quality Assurance Clinical Research
Resume:
CHERYL C. VILLASENOR
CLINICAL RESEARCH PROFESSIONAL
C: 661-***-****, email: ***********.**************@*****.***
Result drive professional with years of experience in Cardiovascular, Nephrology and Immunology clinical research.
Highly motivated and intuitive; excellent interpersonal skills, excellent problem solving skills, able to manage both
time and resources to maximize productivity. Has high capacity of enthusiasm in understanding complex protocols
and guidelines. Dependable, flexible and very adaptable. Attention to detail and accuracy; great analytical and
organizational skills. Open to flexibility of heavy travel .
Desired Position: Clinical Research Associate I Desired Salary: $58 K/Annual
Job Order Number: 50318
Summary: To utilize and translate my professional experience in Clinical Research to higher
management.PROFESSIONAL EXPERIENCE:
LEAD CLINICAL RESEARCH COORDINATOR NEPHROLOGY CLINICAL RESEARCH
Valley Renal Medical Group, Northridge California: April 2012 Nov.2012.
Responsible for running and oversight of the following trials:
ROCKWELL PARENT TRIAL: PPD IRON ANEMIA CKD STUDY
ROCKWELL EXTENSION TRIAL: PPD IRON ANEMIA CKD STUDY
OTSUKA SALACIA TRIAL: HYPONATREMIA CKD STUDY
OTSUKA HYPONATREMIA REGISTRY TRIAL
BRISTOL MYERS: DM2 CKD STUDY
ELI LILLY IMAGINE 2 TRIAL: DM2STUDY
FIBROGEN FGN 053 TRIAL: ANEMIA CKD STUDY
HOSPIRA EPOE 01 & EPOE13 TRIALS: ANEMIA CKD STUDY
BIOGEN/BIIB ATLAS TRIAL: LUPUS NEPHRITIS STUDY
GFRF TRIAL: ELI LILLY: DM I, II & CKD STUDY
CYTOCHROMA TRIAL: VIT D. STUDY
SANDOZ/ACCESS TRIAL: PPD ANEMIA/CKD STUDY
Main Responsibilities:
Managed overall integrity of research.
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Lead and Monitored effectively with team to determine the study population demographic and analyzing the
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needs of the study enrollment goal.
Proactive Team Player and demonstrated excellent outcome through Leadership.
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Monitored and Ensures the conduct if the trial in compliance with the approved protocol/amendment(s), GCP
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and applicable regulatory requirements effectively.
Oversaw the overall clinical operations related to the proper conduct and safety of the trial.
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Collaborative work with the sponsor, primary investigator and staff.
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Effective leadership/ Main focal point of communication to the Sponsors/CRO’s.
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Ensures and Monitored the Investigators follows the approved protocol.
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Managed and responsible for monitoring of daily function of Investigators, Clinical Research Coordinators and
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Research Assistants effectively.
Monitored and Responsible for Training the study conduct to new Coordinators, Research Assistants and other
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study staff.
Developed system of maintaining Subject Files and Source Documents.
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Years of experience in monitoring the accuracy of Electronic Data Capture entry in timely manner.
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Evaluate and Monitor the accuracy of SAE Reporting through Electronic Data Capture.
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Implemented daily Electronic Data Capture Query resolution.
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Verifies and maintain source documents and maintaining accuracy.
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Protocol development, maintains regulatory documents, GCP/ICH and IRB’s.
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Authored site’s SOP’s.
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Ensured compliance and Monitored Standard Operating Procedures and Quality Assurance.
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Head SOP’s and Quality Assurance and Quality Control.
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Monitored the weekly evaluation of clinical trial site study timeline.
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Responsible for Site Start up and maintenance of Regulatory documents.
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Ensured compliance of Site Staff to Sponsors SOP and GCP.
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Developed and Created Source Documentation Form as needed.
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Ensured and Monitored proper documentation specifications are in place during the trial.
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Attended and participated in numerous Investigators Meetings as needed.
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Responsible for organizing the Site Initiation Visit, Monitoring Visit and Close Out Visit.
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Implemented a recruitment plan to ensure long term enrollment.
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Created a Monitoring system for enrollment updates for the clinical team.
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Responsible for oversight of Multiple Trials.
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Responsible for Clinical Trial Contract Evaluation and Budget Negotiations.
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Developed internal system for quality assurance.
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Worked in collaboration with trial team to ensure accuracy.
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Created the ICF Process to depict the critical safety information of consenting.
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Screening, recruiting and enrolling participant.
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Ensuring database accuracy of documentation.
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Dispensing and accountability of investigational products.
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Responsible for daily specimen shipment accuracy.
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HEAD CLINICAL RESEARCH COORDINATOR IMMUNOLOGY CLINICAL RESEARCH
Medvin Clinical Research, Beverly Hills California: May 2011 – April 2012
Responsible for running and oversight of the following trials:
ACT– FIRST Trial – ROCHE
PREDICT Trial RA0064– UCB
ARDEA LASSO Trial ARDEA Biosciences
CLEAR 301 Trial – ARDEA Biosciences
CRYSTAL 304 Trial –ARDEA Biosciences
C EARLY RA0055 Trial UCB
EXXELERATE RA0077 TRIAL –UCB
Main Responsibilities:
Served an integral role in managing the overall integrity of research.
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Oversaw the overall clinical operations related to the conduct of the trial.
•
Worked in collaboration side by side with the Primary investigator and staff.
•
Proactive team player and demonstrated excellent Leadership outcome.
•
Served as focal point for the site for communication with the Sponsors and CRO’s.
•
Lead and Monitored with team to determine the study population demographic and analyzing the needs of the
•
study enrollment goal.
Managed and responsible for Monitoring of daily function of Clinical Coordinators and Research Assistants and
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Interns.
Responsible and Monitored the Training the study conduct to new Coordinators, Research Assistants and other
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study staff.
Responsible and Monitored the Training the study conduct to the Investigators as needed.
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Developed and Created Source Documentation Form as needed.
•
Developed system of maintaining subject files and source documents.
•
Years of experience in monitoring the accuracy of Electronic Data Capture entry in timely manner.
•
Evaluate and Monitor the accuracy of SAE Reporting through Electronic Data Capture.
•
Implemented daily Electronic Data Capture Query resolution.
•
Responsible for Site Regulatory Start up, and Maintenance throughout the study duration.
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Protocol development, maintains Regulatory documents, GCP/ICH and IRB’s.
•
Ensured and Monitor the compliance of Standard Operating Procedures and Quality Assurance.
•
Authored and developed site’s SOP’s.
•
Ensured and monitored the compliance of Site Staff to Sponsors SOP and GCP.
•
Responsible for updating regulatory documents all throughout the duration of study
•
Ensured proper documentation specifications are in place during the trial.
•
Attended and participated in numerous Investigators Meetings as needed.
•
Responsible for organizing Site Initiation Visit, Monitoring Visits and Close Out Visits.
•
Implemented a recruitment plan to ensure long term enrollment.
•
Created a monitoring system for enrollment updates of every study for the clinical team.
•
Responsible and Monitored for oversight of multiple trials.
•
Responsible for Contract and Budget negotiations.
•
Developed internal system for Quality Assurance.
•
Worked in collaboration with the trial team to ensure accuracy.
•
Created the ICF Process to depict the critical safety information of
•
consenting.
Screening, recruiting and enrolling participant.
•
Ensuring database accuracy of documentation.
•
Dispensing and accountability of investigational products.
•
Responsible for daily specimen shipment accuracy.
•
HEAD CLINICAL RESEARCH COORDINATOR CARDIOVASCULAR CLINICAL
RESEARCH
Kumar Medical Corporation, Lancaster, California: May 2006 June 2011
Responsible for running and oversight of the following long term multiple trials:
RELY ABLE Trial Boehringer Ingelheim
TRILOGY ACS Trial – Duke Clinical Research Inst. & Eli Lilly
RELY Trial Boehringer Ingelheim
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RED HF Trial – Amgen Pharmaceutical.
EARLY ACS Trial Duke Clinical Research Inst.
SOLSTICE Trial – Duke Clinical Research Inst.
EXTENSIVE EXPERIENCE IN FOLLOWING CARDIOLOGY AREAS:
Served as Cardiologist Scribe during hospital rounds.
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Trained to evaluate clinical patient for triage prior to cardiology evaluation.
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Trained to respond to patients’ immediate needs.
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Trained to manage difficult patients’ conditions and concern.
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Trained to assess post op cardiac procedural patients.
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Trained to assist Nuclear MPS Stress Test.
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Trained to assist CAT Scan Testing.
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Developed Anticoagulation Clinic Protocol.
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Head Supervisor in charge of Anticoagulation Clinic.
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Responsible for Coagulation Clinic Teachings.
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Responsible for Anticoagulation Clinic Billing Audit.
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Trained to assist ECG’s Reading and Holter Monitors.
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Trained and Monitored In staff support for PACEMAKER CLINIC
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Trained and Monitored evaluate and assess Heart Failure patients.
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Trained to evaluate adverse effect of medications.
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Trained to assess and evaluate VIP send out patients for special referrals.
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Served an integral role in managing the overall integrity of research.
•
Oversaw the overall clinical operations related to the conduct of the trial.
•
Worked in collaboration side by side with the primary investigator and staff.
•
Served as focal point for the site for communication with the sponsors.
•
Proactive team player and demonstrated excellent outcome.
•
Managed and responsible for Monitoring of daily function of Clinical Coordinators and Research Assistants.
•
Responsible for Training and Monitored the study conduct to new Coordinators, Research Assistants and other
•
study staff.
Developed system of maintaining subject files and source documents.
•
Years of experience in monitoring the accuracy of Electronic Data Capture entry in timely manner.
•
Protocol development, maintains regulatory documents, GCP/ICH and IRB.
•
Authored and developed site’s Standard Operating Procedures.
•
Ensured and Monitor the compliance of Standard Operating Procedures.
•
Ensured and Monitor the compliance of SOP Quality Control and Quality Assurance.
•
Responsible for updating regulatory documents.
•
Ensured and Monitored proper documentation specifications are in place during the trial.
•
Attended and participated in numerous investigators meetings as needed.
•
Responsible for organizing site initiation visit and monitoring.
•
Implemented a recruitment plan to ensure long term enrollment.
•
Created a monitoring system for enrollment updates for the clinical team.
•
Responsible and Monitored oversight of multiple trials.
•
Responsible for Contract and Budget Negotiations.
•
Developed internal system for quality assurance.
•
Developed and Created Source Document as needed.
•
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Worked in collaboration with the trial team to ensure accuracy.
•
Screening, recruiting and enrolling participant.
•
Ensuring database accuracy of documentation.
•
Dispensing and accountability of investigational products.
•
Responsible for daily specimen shipment accuracy.
•
CLINICAL TRIAL TRAININGS and INVESTIGATORS MEETINGS:
TRILOGY ACS Trial/DUKE ELI LILLYGCP and Protocol, 2008 Denver, Atlanta and Chicago
RELY Trial/Boehringer Ingelheim GCP and Protocol, 2008, Houston, Austin and San Diego
SOLSTICE ACS Trial/ DUKE Research Inst. GCP and Protocol, 2009 Chicago
Early ACS Trial/ DUKE Research Inst. GCP and Protocol, 2008 Lancaster, California
RED HF Trial/ AMGEN GCP and Protocol, 2008, Irvine and Beverly Hills
PREDICT Trial UCB GCP AND Protocol, 2011 Beverly Hills
ACT FIRST Trial/ ROCHE PHARNANETGCP and Protocol 2011, Beverly Hills and New Orleans.
ARDEA –CLEAR TRIAL– GCP/ PROTOCOL FEB, 2012, San Diego.
ARDEA – CRYSTAL TRIAL –GCP/PROTOCOL FEB, 2012, San Diego
C EARLY RA0055 TRIAL UCBGCP/PROTOCOL MARCH, 2012
EXXELERATE RA0077 TRIAL–UCB GCP/PROTOCOL MARCH, 2012
ROCKWELL RMTI PPDTRIAL GCP/PROTOCOL APRIL, 2012
ROCKWELL RMTI PPD TRIAL/ EXTENTION GCP/PROTOCOL AUG.2012
OTSUKA SALACIATRIAL ICON GCP/PROTOCOL APRIL 2012
BRISTOL MYERS –MB102 073 TRIAL GCP/PROTOCOL APRIL 2012
IMAGINE 2 ELI LILLY TRIAL GCP/PROTOCOL APRI, 2012
FIBROGEN FGN 053 TRIAL GCP/PROTOCOL APRIL 2012
HOSPIRA EPOE 01 & EPOE/13 TRIALS GCP/PROTOCOL APRIL 2012
MAYO CLINIC: IATA 2.0 / HAZMAT: JUNE 2011 JUNE 2013
GCP / ICH: Nov.2011 Nov.2012,CITI GCP: JAN.2013
HIPAA Training for Researcher 2012.
SANDOZ PPD CKD/ANEMIA TRIAL: GCP/PROTOCOL, Investigators Meeting. Chicago, IL Oct 2012
LABORATORY TRAININGS:
QUINTILES LABORATORY, COVANCE LABORATORY
AVERITY LABORATORY, ICON LABORATORY
MEDTOX LABORATORY, DAVITA LABORATORY
SPECTRA LABORATORY
INTERNAL REVIEW BOARD TRAININGS:
COPERNICUS IRB, SCHULMAN IRB
ENGLAND IRB, STERLING IRB
WESTERN IRB, QUOROM IRB
ASPIRE IRB
COMPUTER SYSTEMS YEARS OF EXPERIENCE:
Clinical Trial Computer Systems:
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EDC ORACLE INFORM Version 4.5, EDC RAVE 5.6, iDATA, MEDI data, INVIVO DATA, BRACKET,
ePRO, eDIARY, Epip, PPD,SPECTRA AVERITY,TRIDENT, IVRS SYSTEM: IVRS, IXRS, ARES, IWRS.
OTHER COMPUTER SYSTEMS: EXCEL, POWERPOINT, OUTLOOK.
EDUCATION:
Bachelors of Science in Nursing, 1993
Vocational Nursing,2006
RECOGNITIONS:
TRIOGY–ACS: GLOBAL HIGHEST ENROLEE APRIL 2010
RELY TRIAL WEST COAST and USA HIGHEST ENROLEE 2008
EARLY ACS TRIAL HIGHEST ENROLEE US 2008 2010
GUEST SPEAKER: CARDIOVASCULAR NURSING SYMPOSIUM
Topic: “The NEW ANTIPLATELET DRUG “PRASUGREL” November 2009
GUEST SPEAKER: CARDIOVASCULAR NURSING SYMPOSIUM
Topic: “ANTI THROMBOTIC DRUG “PRADAXA”, October, 2010.
PROFESSIONAL REFERENCES UPON REQUEST
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