HIMANSHU PATEL

adxvx0@r.postjobfree.com 908-***-**** www.linkedin.com/in/himanshu510

Exceptionally organized and detail-oriented, resourceful individual with strong planning and prioritization skills and degree in Doctor of Medicine interested in the position of a clinical Research Associate. Coming with a skill set covering project and process management. Planning. Communication. And interpersonal skills developed from hands-on progressive experience in the healthcare industry and with exceptional research skills and Certification in Good Clinical Practice.

Clinical Research Training:

Clinical Research Fastrack Mar. 2023

Clinical Research Training covering Core Competencies including:

● ICH GCP E6 R (2)

● FDA Regulations 21CFR 11, 50, 54, 56 and the

Common Rule 45CFR46

● Data Management

● Informed Consent Process

● Clinical Trial Operations from feasibility

through close-out

● GDP following ALCOA-C principles

● Identification and reporting of AEs and SAEs

● Quality Assurance, Monitoring and Query

Resolution

● Comprehension and Execution of Clinical Trial

Protocols

● Maintaining a regulatory binder, housing

essential documents including but not limited to

1572, DOA, Training Logs and other

Investigator Site File (ISF) documents

Clinical research associate training, The VIARES academy, Remote Sep. 2022

Experienced in Clinical Research Associate roles and responsibilities acquired at the VIARES Academy Vienna as a Trainee.

Specified on industry competencies in Clinical Research, Pharmacovigilance and Regulatory Affairs.

Also, understood and gained more knowledge on the clinical Research topics ranging from: 1. Background of medicines development

2. Research and discovery stage & product development 3. Clinical development

4. Regulatory submission, Health Technology Assessment, lifecycle management 5. ICH GCP and other applicable regulations

6. Applicable national and international regulatory(EU and USA) requirements including ICH GCP E6 (R2) 7. Requirements for audits and inspections

8. Need of compliance in all activities of Clinical research associate role 9. Sponsor's obligation to develop and implement a quality assurance system including company-specific Standard Operating Procedure SOPs

10. Skills required before, during and after inspections audits 11. Ability to recognize and deal with misconduct and suspected fraud

*Clinical Trial Design & Clinical Research Roles and Responsibilities 12. The Study Protocol -Elements of a Study Protocol according to ICH GCP, Trial Design, Methodologies 13. Roles and responsibilities -Ethics committees, sponsor monitor, investigator, competent Authority

*Selecting and Initiating Clinical Trial Sites

14. Understanding of how to assess an investigational site 15. Possible strategies for upgrading investigational sites (e.g. training, sourcing, equipment) 16. Development or the skills to plan, organize, conduct and document site initiation

*Monitoring and Closing Clinical Trial Sites

17. Strategies for increasing site performance

18. Development or the skills to plan, organize and conduct and document monitoring visits, close-out visits

*Patient Protection & Adverse Events

19. Understanding of the patient information and informed consent process 20. Verity that the process of obtaining informed consent has been adequately performed and documented 21. Identity adverse events and to differentiate between the types of adverse events according to the ICH guidelines 23. Familiarized with the applicable adverse event reporting processes. Formats and follow-up requirements

*Investigational Medicinal Product Management

24. Understanding of what an investigational product IP is including comparators and placebo 25. Understanding of how the defined investigational drugs) need to be managed 25. Understanding of how the IP has to be dispensed and administered to patients according to protocol and how to verify compliance

26. Understanding of the randomization process and the related documentation requirements including unbinding procedures)

*Data Management for Clinical Research Associates

Understanding of how the case report form (CRF) relates to the study protocol and to relevant regulatory, GCP, requirements

Understanding how to collect clinical trial data by means of CRES (Paper and or electronic)

Understanding of the applicable monitoring and data validation plans and how to comply with them

Understanding or when and how to initiate and how to resolve data queries Certificates & Training:

● Good Clinical Practice - ICH E6 (R2) Clinical Research Fastrack - TransCelerate Approved Mar. 2023 Relevant Skills:

● Strong ability to show empathy and compassion

● Medical Terminology, Phlebotomy, Triage

● Data Collection, Microsoft Excel

● HIPPA

● A good communicator, quick learner and excellent time manager

● Always looking forward to learning and growing more

● EMR & Medical billing and coding

Professional Experience:

Medical Scribe

Arvind Doshi MD PA Kendall Park, NJ Oct. 2022- Current

● Input details about patient histories, physical examinations, medications and other information into physical or electronic charts.

● Used EHR system to manage patient records, always maintaining patient confidentiality according to HIPAA standards.

● Followed clinicians throughout shift in high-volume, busy environments. Demonstrated knowledge of terminology for multiple medical specialties, consistently seeking ongoing training to expand and maintain knowledge base.

● Captured and transcribed medical record documentation with electronic medical record applications. Documented and initiated tests, scan and other orders.

● Prepared and sent patient documentation to physician for review and approval via authentication of detailed data entry and facility-specific procedures.

● Reconciled clinical notes, patient forms and health information for compliance with HIPAA rules. Determined correct ICD-10 and CPT codes for use in medical record.

● Demonstrated knowledge of HIPAA Privacy and Security Regulations by appropriately handling patient information.

● Assisting physician with sending prescriptions electronically under his supervision while physician is taking patients Entered data into a computerized patient record system (EMR) Entered all of the details about examinations, treatment plans, lab results, and other details directly into the charts Discussed serious illnesses or diseases with the physician and obtaining knowledge from him.

● Reviewed medical records for accuracy and completion as required by insurance companies. Answered inquiries concerning progress of medical cases within limits of confidentiality laws. Medical Assistant

Vcare Urgent and Primary Care Dayton, NJ April.2022-Oct. 2022

● Prepared treatment rooms for patients by cleaning surfaces and restocking supplies.

● Scheduled appointments for patients via phone and in person.

● Measured vital signs and took medical histories to prepare patients for examination.

● Relayed messages from patients to physicians about concerns, condition updates or refill requests to facilitate treatment.

● Interviewed and engaged patients to obtain medical history, chief complaints and vital signs.

● Organized charts, documents notes during patient visits.

● Cleaned and maintained medical equipment following procedures and standards. Educated patients about medications, procedures and physician's instructions.

● Secured patient information and maintained patient confidence by completing and safeguarding medical records. Assessed, documented and monitored vital signs for patients within outpatient setting.

● Labeled and completed lab requisitions using ICD and CPT coding.

● Performed preliminary physical tests to accurately record results in patient history summary.

● Administered rapid tests for COVID and strep to help clinical staff assess conditions.

● Collected blood, tissue, and other laboratory specimens and sending them for testing Helping PA for minor surgeries Performed EKGs Maintained inventory, vaccination and product expiration logs to record updated documentation for tracking purposes.

● Participated in team meetings to improve workflows and contribute to improving patient population outcomes. Contacted pharmacies to submit and refill patients' prescriptions. Collaborated with local pharmacies to resolve and clarify issues with patient medication.

Doctor

Apollo Hospitals Ahmedabad, Gujarat Jan. 2021- Aug. 2021

● Oversaw day-to-day practice functions, patient care, medical and administrative staff and business activities.

● Improved clinical quality by analyzing performance metrics, patient outcomes and delivery of care.

● Examined patients and recorded medical histories to use in health assessments and help determine conditions.

● Provided health education to patients, families and colleagues.

● Monitored patients with acute conditions for changes, improvements or need for intervention. Advised patients about diet, hygiene and other lifestyle behaviors to promote health and prevent disease.

● Interviewed patients about symptoms and conducted thorough physical examinations.

● Prescribed medications and advised patients about dosage, schedule and possible side effects. Recorded patients' medical history, vital statistics and test results in electronic medical records.

● Provided patient diagnosis, test evaluation and treatment under strict time constraints. Monitored treatment regimens to determine efficacy and adjusted according to results achieved.

● Ordered laboratory tests and imaging scans to complete further investigations. Implemented treatment plans for disorders, heart disease, hypertension and diabetes.

● Consulted with specialists and referred patients for more advanced support based on individual needs. Referred patients with serious medical conditions and emergencies to hospital for immediate care.

● Maintained strict patient privacy and confidential patient information, taking care to meet HIPAA guidelines and statutes for data security.

● Recommended dietary changes and fitness activities to improve overall health and boost longevity. Utilized mobile, tablet and laptop technology to inform and educate patients about medical conditions.

● Medical monitor for covid vaccines trial, monitor sAEs and informed the authority and treat the population accordingly.

My role as a research assistant for covid-19 Antibody therapy study on recent Covid positive subjects included but not limited to: Ahmedabad, India

Pre-screening and enrolling patients for the clinical studies

Performing EPIC chart review, screening, scheduling subjects and maintaining study files

Obtaining Informed consent from potential study participants

Obtaining vital signs, ECG, blood draws, processing and shipment of labs

Preparing and maintaining clinical trial source documents

Maintaining Patient Study files in a systematic order

Maintaining documentation regarding all aspects of the study

Source Document creation under the guidance of study coordinator

Maintaining the Regulatory binder.

Research Assistant

Perpetual Help Medical Center Las-pinas, Philippines Nov.2019-Dec.2020

Assist in the preparation and presentation at investigator meetings, as required to ensure that the clinical and investigational site staff team are well informed about the study and related procedures.

Maintaining a working copy of the Central Investigator File & ensuring consistency with the Site Investigator File in order to maintain a working record of all essential documents and reports.

Perform source document verification as per monitoring plan and ensure that source documents & other trial records are accurate, complete, kept up-to-date & maintained according to applicable SOPs to avoid incomplete records.

Ensure timely collection of documents like CRF, DCF, etc., from the site along with SAE reports in order to provide Biometrics/licensing authority & others with the necessary documents.

Responsible for study updates & Coordination with Labs & other trial-related services as per the study requirements.

Responsible for IP accountability and availability, tracking and management of all Clinical Trial related supplies shipped to the sites/ warehouse & accordingly clinical trials supplies vendor management for the study

Ensure proper escalation of site/project-related issues to the Project Manager/ Designee in a timely manner.

Responsible for site-closeout & follow-up activities in order to maintain documents at the site, Attend staff meetings and training sessions as required to complete the training curriculum in a timely manner.

Assist with the audit of an investigational site or central files and liaise with Quality Assurance personnel as required to ensure that the study is being conducted in accordance with ICH GCP and applicable regulatory guidelines, To liaise with other departments within the organization for timely achievement of the project milestones.

Ensure to follow and adhere to organizations' general rules, policies, and applicable SOPs. Duty Doctor

Perpetual Help Medical Center Las-pinas, Philippines Nov. 2019-Dec. 2020

Recorded patients' medical history, vital statistics and test results in electronic medical records.

Ordered laboratory tests and imaging scans to complete further investigations. Monitored patients with acute conditions for changes, improvements or need for intervention. Prepared patients for specific treatments.

Updated patient records pertaining to treatment and care. Provided patient diagnosis, test evaluation and treatment under strict time constraints.

Monitored treatment regimens to determine efficacy and adjusted according to results achieved.

Maintained strict patient privacy and confidential patient information, taking care to meet HIPAA guidelines and statutes for data security.

Evaluated nursing notes to confirm accuracy of care provided and patient responses. Referred patients to outside specialists or hospital admission for more advanced care.

Treated patients with strokes, head traumas, comas and intracranial hematomas. Acted in liaison role between patients and doctors. Maintained HIPAA compliance across patient data-handling, systems and training.

Examined patients and recorded medical histories to use in health assessments and help determine conditions. Provided health education to patients, families and colleagues. Prescribed medications and advised patients about dosage, schedule and possible side effects.

Interviewed patients about symptoms and conducted thorough physical examinations.

Collaborated closely with fellow medical team members to share knowledge and discuss best courses for treatment.

Referred patients with serious medical conditions and emergencies to hospital for immediate care. Completed continuing education programs to maintain certifications. Contributed to growth and revenue generation through marketing, community events and other relationship-building efforts. Research

Student Awareness On Heart Disease

University of perpetual help system dalta, laspinas, Philippines Jun.2016 Education:

Basic Life Support Certification for Healthcare Professional 2023 Doctor of Medicine Jonelta Foundation School of Medicine Philippines 2020 AB in Psychology University of Perpetual Help System Dalta Philippines 2016

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