Engineer Microsoft Office

Career Summary

-A highly talented and potential Biomedical Engineer with profound experience in a wide variety of areas including but not limited to clinical trials involving human participants for medical devices that will make the treatment more patient friendly

- Practical knowledge of ICH and GCP guidelines including basic understanding of regulatory requirements and HIPAA

- Proficient in training the surgeons and OR staff

- Hands-on experience with real time troubleshooting and problem solving

- Proven expertise with research and product development

- Experience in data collection and documentation

- Highly skilled in Microsoft Office products, such as Word, PowerPoint, and Excel

Work Experience

Clinical Research Associate - Intern: Clinproxy Research Services (May 2016 – Present)

Member of the clinical development team

Evaluated and selected potential investigators

Developed Investigator's Feasibility Questionnaire, Research Site/Investigator/Study Staff Evaluation Forms, Sponsor/Investigator's Agreement, Investigator's Brochure, and Patient's Brochure

Designed Clinical Trial Protocol, Standard Operating Procedures (SOPs), and Case Report Forms (CRFs)

Prepared Study Event Schedule, Randomization Schedule, and Investigator/Staff Training Plans

Created reports of adverse events in compliance with IRB stipulations and in accordance with FDA regulations and ICH guidelines

Designed Informed Consent Form, Patient Questionnaire, and Subject Monitoring Logs

Validated inclusion/exclusion criteria and evaluated patient enrollment

Developed templates for study initiation deliverables (checklist for site evaluation, initiation, monitoring, close-out; subject screening, recruitment, and visit logs, drug accountability logs)

Prepared customized study documents like site report templates, delegation logs, enrollment logs etc. to ensure that study is conducted in compliance with SOP and specific study requirement

Prepared documents for IRB submissions and performed required follow-ups

Product Development Engineer: Thermaissance, India (Feb 2014 – Jun 2015)

Developed a functional, comfortable and stylish clothing for chemotherapy, dialysis, dementia and diabetes patients

Collaborated with doctors, nurses, and patients to create specifications

Evaluated the product and its components for ICH and GCP compliance

Conducted research to develop sensors to monitor vital signs and QR codes that hold patient information embedded in the clothing

Assisted in research and testing of various fabric technologies, including water resistance, temperature control, and antimicrobial treatment

Worked with focus groups to incorporate suggestions and feedback in product iteration

R&D Engineer: Clique Medical, India (Jun 2012 – Dec 2013)

Worked on development of a handheld device to detect counterfeit/expired drugs

Focused on research of different wavelengths of light, such as UV and infrared, to utilize in detection

Researched and tested multiple light emitting devices to generate specific frequencies to inspect color, brightness, and shape of tablets, capsules, and packaging to test their authenticity when compared against a database of genuine products

Field Clinical Specialist: Perfint Healthcare, India (Sep 2010 – Mar 2012)

Participated in iterative testing of planning and targeting solutions for image guided robotic positioning system that assists with precise tumor targeting and probe placement

Trained oncologists and OR staff on how to operate the device

Troubleshot various technical problems during the device use in the OR

Interacted with doctors and medical professionals to gather feedback on improving the device

Documented technical details on operating and maintaining the device

Field Application Engineer: Dune Medical Devices Inc., Manhattan, NY (Sep 2008 – Feb 2010)

Performed protocol compliance, data collection, reports/trends generation and clinical trial activities

Trained surgeons with device use, guided them to perform phantom tests and assisted them during surgeries with system checks and technical issues

Troubleshot various technical problems during the device use in the OR

Trained pathologists with specimen processing and attended gross assessments of specimens at Pathology labs

Assisted CRA in site monitoring

Researched breast cancer lumpectomy procedures and helped generate a dataset from trial patients

Actively participated in site initiation visits and spearheaded the responsibility of 2 out of 5 sites in the NY cluster, including compliance check for site monitoring, management, and administration with ICH and GCP guidelines

Education

Certification in Clinical Research Professional Development Program, KRC International

(May 2016)

- Clinical trial monitoring and research site coordination

- The International Conference on Harmonization (ICH) guidelines

- Good Clinical Practice (GCP) guidelines

- Health Insurance Portability and Accountability Act (HIPAA)

M.S Biomedical Engineering, New Jersey Institute of Technology, New Jersey

(GPA: 3.86)

B.S. Mechatronics Engineering, G.H. Patel College of Engineering & Technology, India

(GPA: 3.75)

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