Harshitha Botumanchi

***** **** *** *****, ** ***47 612-***-**** ad20rx@r.postjobfree.com www.linkedin.com/in/harshitha-botumanchi

Profile

I am a results-driven student with a strong medical background currently pursuing a Master's in Applied Clinical Research with a focus on medical devices. Proficient in research protocols, FDA regulations, and clinical trial operations. Skilled in project management, clinical trial software, and data management. Detail-oriented problem solver with a keen interest in enhancing healthcare systems. Quick learner and team player with clinical experience seeking a dynamic role in a clinical research environment.

Education

Master of Science: Applied Clinical Research St Cloud State University - Plymouth, MN Expected Grad- 12/2025

Completed Coursework in

Clinical Study Design and Planning, focusing on following key areas-

Able to define and develop the required and desired components of an investigational plan (protocol)

Project management responsibilities

Gained expertise in creating a Project Management Plan, Device Accountability Log, and Protocol Synopsis

Clinical Study Operations and Execution, focusing on following key areas-

Clinical Trial Software Proficiency -Utilize advanced skills in Veeva eTMF for seamless management of clinical trial documentation and processes.

Establish and execute an investigative site selection and qualification process.

Prepare investigative site activation materials.

Establishing a data management plan

Biostatistics for Clinical Trials

Understanding statistical rationale for clinical trials

Understands some key statistical concepts, including hypothesis testing, p-value, confidence interval, type I error, type II error, statistical power, and sample size

Understands data elements in a clinical trial, including endpoint definition, data and safety monitoring, inclusion and exclusion criteria and how those are related to biostatistics

Can understand of common statistical analysis strategies and issues in FDA trials

Doctor of Pharmacy Joginpally B.R Pharmacy College, Jawaharlal Nehru Technological University – INDIA 08/2022

Completed comprehensive coursework in pharmaceutical sciences, Pharmacology, Pharmacotherapeutics, Toxicology, Clinical research and Methodology, and healthcare management.

Gained expertise in drug interactions, pharmacotherapy, Monitoring activities and patient care management.

Developed strong analytical and problem-solving skills through coursework and hands-on clinical experiences.

Engaged in research projects and presentations, showcasing a commitment to academic excellence and contribution to the field.

This Doctor of Pharmacy degree has equipped me with a solid foundation in pharmaceutical sciences and clinical expertise, enhancing my ability to contribute effectively to the healthcare industry.

Experience

Duty Medical Officer GK Specialty Hospital – Balapur, India 08/2022 - 12/2022

Led a diverse team of medical and administrative professionals in day-to-day clinic activities such as patient care, Monitoring adverse reactions and patient counseling under Dr. V. Gopi Krishna.

Assisted Bronchoscopy, Thoracoscopy, Tube Thoracocentesis, Pleural biopsy, Pleurodesis FNACs, and USG guided FNAC in pulmonology and general medicine departments.

REFERENCE

Dr. V. Gopi Krishna

MBBS, MD. PULMONOLOGIST

Asst. Prof.(TIMS)

Reg.No: 85954

ad20rx@r.postjobfree.com

Pharmacy Intern Mahavir Institute of Medical Sciences and General Hospital – India 08/2021 - 08/2022

Managed various drug interactions, interventions and adverse drug reactions

Worked in the department of General Medicine, Urology, Pulmonology, Pediatrics, Gynecology and Dermatology each for a period of 1-2months acquired set of skills like:

Managed Outdoor patient department including weekly specialty clinics.

Performed ward rounds on daily basis for inpatients

Managed ICU patients routinely

Attended seminars and case discussion sessions every week in the hospital

Skills & Abilities

·Excellent critical thinking and decision-making skills

· Good Clinical Practice and SOPs

·Good listening and Problem-Solving skills

·Proficiency in the use of Microsoft Office Suite of tools (Outlook, Word and Excel)

·Preventive Care, Diagnosis, and Treatment

·Excellent written, verbal, and interpersonal communication skills

· Research, Data entry, and Collection skills

·Clinical Trial Software Proficiency- Veeva eTMF

Scientific Research & Certifications

IRB training for graduate student Collaborative Institutional Training Initiative (CITI) 30/NOV/2023 - 30/NOV/2028

Under requirements set by: St. Cloud State University completed Collaborative Institutional Training Initiative (CITI) “Basic/Refresher Course - Human Subjects Research” IRB Training for Graduate Students, Stage-1 Basic course. Record ID 59898091

A solid understanding of ethical considerations and regulatory compliance in clinical research.

This reflects my commitment to conducting research responsibly, aligning seamlessly with the ethical standards and protocols essential for contributing to high-quality clinical trials.

Dissertation KIMS Hospital – Secunderabad, India 06/2020 – 03/2021

“AN OBSERVATIONAL STUDY ON EFFICACY AND TOLERABILITY OF MIRABEGRON COMPARED WITH SOLIFENACIN IN PATIENTS WITH OVERACTIVE BLADDER” under the guidance of Dr M. GOPICHAND, MS, DNB urology, Professor, HOD of urology department, KIMS HOSPITAL, Secunderabad over 8 months, India.

Obtained Informed Consent

Screening and enrollment

Quality of life questionnaires and patient counseling

Paper publication in international journals 03/2019-02/2020

“ALZHEIMER'S DISEASE” published in IJSRR JOURNAL, volume8, issue1, January-2019

“PHAGE THERAPY – A NEW WEAPON TO FIGHT AGAINST THE SUPERBUGS” published in IJSRR JOURNAL, volume 6, issue 1, March 2019.

Presentation India 08/2019-02/2020

Oral presentation on –Na+/K+-ATPase role in cell death in DWARKA 2K19, a 10th National level conference held at Geethanjali College of Pharmacy, Telangana, India 08/2019

Poster presentation – APPLICATION OF 3D PRINTING TECHNOLOGY at USG Sponsored International seminar on Advanced Technologies in Pharmaceuticals- past present and future held at Acharya Nagarjuna University, Guntur, A.P, India 02/2020

Languages

English - Full Professional

Telugu - Native or Bilingual

Hindi - Bilingual

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