Permanent Resident of USA
Dedicated 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.
• 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 training
DUKE CANCER INSTITUTE- MEDICAL CENTER
Clinical 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 INSTITUTE
Los Angeles, CA
Clinical 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 & HOSPITALS
Clinical 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 needles
YASHDEEP 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. 01/2011
EDUCATION AND TRAINING
M.B.B.S: BACHELOR'S OF MEDICINE AND BACHELOR'S OF SURGERY Shenyang Medical College, China (2005- Continue)
Certified NIHSS & MRS, Los Angeles, CA (2018)
Clinical Research Specialist/Regulatory Affair Course, (Wake Tech.) Raleigh, NC
NHA Certified Phlebotomy Technician,Certificate Number F5K3L2Z2 (Durham Tech) Durham, NC (05/18/2017- -5/18/2021)