BHADRESH PRAJAPATI

Permanent Resident of USA

Knightdale, NC

Home: 919-***-****

adc9ha@r.postjobfree.com

SUMMARY

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.

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 training

EXPERIENCE

DUKE CANCER INSTITUTE- MEDICAL CENTER

Durham, NC

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

Raleigh, NC

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)

CERTIFICATIONS

Certified 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)

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