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Click here or scroll down to respond to this candidateCandidate's Name
Permanent Resident of USAKnightdale, NCHome: PHONE NUMBER AVAILABLEEMAIL AVAILABLESUMMARYDedicated Clinical Research Associate experienced in complying with study protocols, standard operating procedures and good clinical practices. Practiced problem-solver with strong attention to detail. Prepared to utilize my medical experience and conduct research in an ethical and safe manner.SKILLS Data entry Medical records maintenance Patient education Quality control Medical device products and services Fluent in English, Chinese, Gujarati, and Hindi Talent in obtaining/charting vital signs Recruiting and trainingEXPERIENCEDUKE CANCER INSTITUTE- MEDICAL CENTERDurham, NCClinical Research Specialist Sr, Oncology Department, Full Time-40 hrs. Week (paid biweekly) 10/14/2019- Current Current diseases focus on Acute and chronic Leukemia, Multiple Myeloma, Lymphoma, solid tumors, bone marrow and stem cell transplant. Participate in the development of investigator-initiated trails from phase I to IV Obtain inform consent form and enter into system, assist with clinical trial budgets and patient research billing Collect intra-Procedure data from EPIC and enter into EDC and utilization of Good Clinical Practice, Good Laboratory Practice and Hazard Analysis Critical Control Points. Analyze/report protocol deviations and adverse event in timely manner Facilitate and assist site initiation visits, site monitoring visit, site close out visit, audits accountability process, File and maintain study subject binders and corresponding emails, regulatory and administrative binders. Submission of SAE/Safety Letters in accordance with the FDA CEDARS-SINAI MEDICAL CENTER-HEART INSTITUTELos Angeles, CAClinical Research Associate I, Cardiology Department, Full Time-40 hrs./week (paid biweekly) 06/04/2018 to 10/4/2019 Current disease focus on Mitral Valve and Aortic Valve disease, ensuring compliance with SOPs, local regulations, ICH/ GCP Participate in the development of investigator-initiated trials, present patient cases to PI for approval Obtain participant informed consent form, schedule/screen patients for research trials, perform pre-op/post op, follow up research clinical assessments and present to sponsors for approval Collect intra-procedure data from EPIC and enter into EDC as well as TVT Registry, analyze/report protocol deviations and adverse events in a timely manner Complete CRFs, research data entry into EDCs, CTMS, upload/ maintain subject Echo,CT scan data into BioClinica Facilitate and assist site initiation visits, monitoring visits, audits File and maintain study subject binders, Regulatory and administrative binders Assist with regulatory submissions to IRB, submissions of SAE/Safety Letters in accordance with the FDA Collect, process and ship blood samples, prepare, ship and maintain study supplies and kits. Assist with clinical trial budgets and patient research billing WAKEMED HEALTH & HOSPITALSRaleigh, NCClinical Services Technician (Phlebotomist), Full Time-40 hrs./week (paid biweekly) 07/12/2017 to 05/25/2018 Coordinated workflow based on stat, schedule, or outpatient needs Counseled patients to ease fears, explain procedures and enhance cooperation during blood draws Obtained variety of blood samples through venipuncture or capillary puncture using syringes, butterfly needles, and straight needlesYASHDEEP HEART HOSPITAL/DEVARSHI SUPERSPECILISTY HOSPITAL, INDIA Medical Doctor, Full Time-40 hrs./week (paid 1st of every month) 01/01/2011 to 10/17/2015 Routine examination of patients recognizing signs/symptoms of various illness to order appropriate tests and prescribe treatments. Assisted doctors with surgeries, non-invasive procedures. Also, provided non-routine Phlebotomy services Monitored infection control, critical incidents, risk management and quality improvement plans. Additionally, helped as a language interpreter to team members specifically in translating clinical data. 01/2011EDUCATION AND TRAININGM.B.B.S: BACHELOR'S OF MEDICINE AND BACHELOR'S OF SURGERY Shenyang Medical College, China (2005- Continue)CERTIFICATIONSCertified NIHSS & MRS, Los Angeles, CA (2018)Clinical Research Specialist/Regulatory Affair Course, (Wake Tech.) Raleigh, NC(2017-Continue)NHA Certified Phlebotomy Technician,Certificate Number F5K3L2Z2 (Durham Tech) Durham, NC (05/18/2017- -5/18/2021) |
