Drug Safety Associate/ Clinical Research Associate

DESIRED POSITIONS
Drug Safety, or Medical Monitor, or Clinical Research Associate (CRA) in cardio-vascular surgery or cardiology clinical trials.•••••HIGHLIGHTS OF QUALIFICATIONS•••••* 1 year medical safety experience; processing Serious Adverse Events (SAE); completed ••••• Medical Device Reports (MDR) and MedWatch reports to FDA at Abbott Vascular, CA.
* 5 years Clinical Research Coordinator (CRC) experience in Cardio-vascular clinical trials.
* Monitored 2 Inter-departmental clinical trials.
* Intensive training for Clinical Research Monitoring by PPD, Inc. and ICON, Inc.: essential documents, informed consent, source documents, monitoring visits.
* MS of Neuroscience. Bachelor Degree of Medicine.•••••WORK EXPERIENCE•••••Quality Assurance Analyst, Abbott Vascular, Temecula, CA
•••••/••••• current•••••* Completed ••••• Medical Device Reports (MDR) and MedWatch reports to FDA for post market regulatory cardiology medical devices.
* Analyzed ••••• customer complaints by gathering data from clinical staff, field representatives, internal employees, and laboratory analysis.
* Applied governmental regulations to determine reportability to FDA, Vigilance (European countries), and MLHW (Japan).
* Completed regulatory reports for Vigilance (European), MLHW (Japan), and other international regulatory authorities and ensured timely transmission.
* Responsible for adherence to Good Manufacturing Practices (GMPs) and proper complaint handling per the CFR ••••• and •••••
* Applied clinical knowledge, as related to product application, to evaluate identified complaints or Serious Adverse Events (SAE).•••••Clinical Research Associate•••••
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PPD, Inc, ••••• Scranton Road, San Diego, CA, USA•••••* Essential documents: commonly required essential documents, collecting and tracking, project team reviewing, regulatory compliance reviewing.
* Informed consent: consent principles, required ••••• elements in consent, FDA requirements, monitoring the consent process, vulnerable populations.
* Source documents verification and case report form (CRF) review: ALCOA, correcting records, certified copy, logic checks, and direct access to source documentation.
* The interim monitoring visit: preparing the visit, site visit log, identify and resolve outstanding issues, the visit report, and the follow up letter.
* Monitoring visits: pre-study, initiation, interim, and close-out visit, documenting contact to the site, handling queries, audits, inspections.
* IRB, questionable data, Investigational Product, site selection, protocol departures, SAE.•••••Clinical Research Coordinator •••••
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Cardiovascular Research, Arizona Heart Institute (AHI), Phoenix, AZ, USA•••••* Performed 8 pharmaceutical sponsored clinical trials in the area of Coronary Investigational Devices/drugs, Cell Therapy, and Gene Therapy. The number of patients consented was •••••
* Liaised with pharmaceuticals, Biotech sponsors, and Contract Research Organizations (CRO): National Heart, Lung and Blood Institute, Abbott Vascular, Boston Scientific Corporation, Sankyo Pharma Development, Volcano Therapeutics Inc., Gene Logic, Inc., Diacrin, Inc., GenVec.
* Execution of the protocol by enrolling research patients into the clinical trial.
* Assisted the Investigator in the OR/Cath lab with study procedure.
* Continued assessment of the patients for AE/SAE reporting.
* Maintained and updated regulatory documents, CRF, and IRB submissions.•••••Clinical Research Coordinator •••••
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Department of Anesthesia for Cardiovascular surgery, Toronto General Hospital, UHN, Toronto, ON, Canada

* Monitored 2 Inter-departmental clinical trials.
* Conducted and assisted ••••• Principle Investigator Initiated clinical trials in cardiovascular surgery.
* The number of patients consented was •••••
* Execution of the clinical trial protocols during pre-operation, intra-operation (operation room), and post-operation (ICU).
* Liaised with pharmaceuticals and CROs.
* Trained 6 part-time and full-time employees. •••••EDUCATION•••••MS of Neuroscience, Dept of Anatomy & Cell Biology,
Queens University, Kingston, ON, Canada
••••• ••••••••••Bachelor Degree of Medicine
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