Clinical Research Data Entry

BHADRESH PRAJAPATI

Cellular: 919-***-****

**********@*****.***

SUMMARY

Dedicated Clinical Research experienced in complying with 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

SKILLS

• Medical device products and services

• Fluent in English, Chinese, Gujarati, and Hindi

• Talent in obtaining/charting vital signs

• Recruiting and training

EXPERIENCE

ICON – Raleigh, NC 12/21/2021-Current

Associated Study Manager, Oncology Department

• 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 trail from phase I to IV. • Analyze/report protocol deviations and adverse events in timely manner

• Collect intra-procedure data from EPIC and make sure data is entered is correct into EDC as well as TVT Registry, analyze/report protocol deviations and adverse events in a timely manner report protocol deviations and adverse events in a timely manner

• Collect, process and ship blood samples, prepare, ship and maintain study supplies and kits and track courier, Make sure courier reach on time to facility.

DUKE UNIVERSITY MEDICAL CENTER -DURHAM, NC

Clinical Research Specialist Sr, Oncology Department 10/14/2019-12/18/2021

• Current disease focus on MML and ACL, 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 presents to sponsors for approval

• Collect intra-procedure data from EPIC and enter 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 to the sponsor, prepare, ship and maintain study supplies and kits.

• Assist with clinical trial budgets and patient research billing CEDARS-SINAI MEDICAL CENTER-Los Angeles, CA

Clinical Research Associate I, Cardiology Department 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) 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 01/01/2011 to 10/17/201

EDUCATION AND TRAINING

M.B.B.S: BACHELOR'S OF MEDICINE AND BACHELOR'S OF SURGERY 01/2011 Shenyang Medical College, China

CERTIFICATION

Certified Clinical Research Specialist (Wake Tech) Raleigh, NC (2017) NHA Certified Phlebotomy Technician (Durham Tech) Durham, NC (2017)

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