Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Generic

Sreevalli Chirumamilla

Fairborn

Summary

As a highly motivated and enthusiastic Pharma D professional and master's student in Pharmacology and Toxicology, Seeking a Clinical Research Associate position in a dynamic and fast-paced pharmaceutical industry. Objective is to utilize extensive knowledge, skills and experience to contribute to the development of innovative and effective treatments and therapies for various diseases and health conditions. With a strong academic background in pharmacology, toxicology, and clinical research, developed a deep understanding of the complex mechanisms of drug action and the impact of toxicity on human health. Also acquired hands-on experience in conducting clinical trials, collecting and analyzing data, and presenting findings authorities. Committed to excellence in clinical research and believe in the power of data-driven decision-making. Additionally, a quick learner and highly adaptable and am able to manage multiple projects simultaneously while maintaining high levels of accuracy and attention to detail. A strong communicator and believe that effective communication is essential in collaborating, As a Clinical Research Associate, would leverage knowledge of GCP and regulatory guidelines, analytical skills, and strong communication abilities to ensure the success of clinical trials. Eager to be part of a team that is dedicated to improving patient outcomes and advancing Clinical Research.

Overview

2
2
years of professional experience

Work History

Junior Data Analyst

cognizant Technology Solutions
Hyderabad
02.2021 - 07.2021
  • Monitoring of adverse event reports: Monitoring and tracking of adverse events related to drug under investigation during phase 4 marketing studies
  • Data collection and management: Collecting and managing data related to adverse events, including patient demographics, medical history, and drug information
  • Risk management and assessment: Assessing potential risks associated with drug and recommending appropriate risk mitigation strategies
  • Literature review Conducting comprehensive review of available literature on drug to identify any potential safety concerns
  • Communication with healthcare professionals: Establishing and maintaining open lines of communication with healthcare professionals to gather information about adverse events
  • Compliance with regulatory guidelines: Ensuring that phase 4 marketing studies are compliant with all applicable regulatory guidelines, such as Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • Reporting adverse events: Preparing and submitting adverse event reports to regulatory agencies, such as FDA and EMA, in accordance with established timelines and procedures
  • Meetings and development: Attend pharmacovigilance meetings and educate to healthcare professionals on adverse event reporting and risk assessment
  • Collaboration with Medical bodies: Collaborating with Various teams, including medical affairs, clinical research, and regulatory affairs, to ensure safety of patients and integrity of data collected
  • Data analysis and interpretation: Analyzing and interpreting adverse event data to identify trends and patterns and to inform risk management strategies.

Clinical Data Coordinator

Moksha Biosciences
07.2020 - 02.2021
  • Generate and maintain study documentation, including study case report forms (CRF) and data management plans.
  • Ensure accuracy and completeness of clinical trial data in electronic databases like EDC (Electronic Data Capture), CDMS (Clinical Data Management System), CTMS (Clinical Trial Management System)
  • Develop and maintain Standard Operating Procedures (SOPs) for data management processes
  • Create study-specific data listings and summary reports
  • Prepare and submit periodic reports on study progress and data quality
  • Compliance with regulatory requirements, including GCP and data privacy regulations
  • Perform data quality checks and audits and assist with database design and development
  • Develop and Maintain study specific data management plans, study tracking systems to monitor study progress and timelines
  • Performing quality control checks on data to identify and resolve inconsistencies
  • Participate in project team, committee meetings and provide regular updates on data management activities
  • Responding to data requests and providing data support for various projects (closeout activates, including archiving of study data)

Clinical and Hospital pharmacist

Care Hospitals
07.2019 - 07.2020
  • Hands on experience under super vision of senior doctors in following departments
  • Nephrology Department:
  • Monitor and evaluate patients' medication therapy to ensure optimal therapeutic outcomes and prevent adverse effects
  • Collaboration with Physicians: worked closely with nephrologists and other healthcare professionals to develop and implement medication treatment plans, ensuring that patients receive best possible care
  • Calculate appropriate dose of medications for patients with chronic kidney disease (according to GFR), ensuring that medication is safe and effective for their condition
  • Internal Medicine Department:
  • Provide medication management and therapy recommendations to physicians
  • Participated in interdisciplinary rounds to ensure safe and effective medication use
  • Educate patients on proper use of medications and potential side effects
  • Manage drug interactions, adverse reactions, and medication errors during rounds
  • Review medication orders to ensure accuracy and compliance with established protocols
  • Pediatrics Department:
  • Clinical support and expertise in management of medications for pediatric patients
  • Collaborate with pediatricians and other healthcare providers to develop and implement therapeutic plans
  • Monitor and adjust medication therapy as needed to meet evolving needs of pediatric patients
  • Written dosing and vaccination charts for pediatric patients
  • Gynecology Department:
  • Monitor and adjust medication therapy for patients with gynecological conditions (endometriosis, PCOS, PID, menopause, ovarian cysts, Cervical cancer)
  • Educate patients and conducted camps on menstrual cycle and menopause symptoms
  • Conduct drug utilization evaluations to identify potential medication-related problems and implement preventive measures

Education

Cellular Pharmacology And Toxicology, Biokinetics/Biodynamics, Research Techniques, Laboratory Management, Pharmacogenomics, Effective Scientific Writing, Clinical Investigation Capstone, Introduction To Pharmacology, Cell Biology, Biochemistry, Six Sigma Green Belt, Lab Safety, Clinical Research Roles And Responsibilities -

Wright State University
Dayton, OH

Cell Culture Training, Human Studies Research, Microbiology, and Immunology, Pharmacotherapeutics, Good Laboratory Practices, Histopathology. - Pharm D

Guru Nanak Technological Institutions (JNTUH)
Hyderabad India

Masters - pharmacology and toxicology

Boonshoft School of Medicine (Wright State University)

Skills

TECHNICAL PROFICIENCIESundefined

Accomplishments

    · Clinical Trials management and coordination – 2023

    · HIPAA (health insurance portability and accountability act)

    · IATA (Integrated approaches to testing and assessment)

    · GCP (Good clinical practice)

    · US Department of Homeland Security (FEMA) – Introduction to incident command system ICS-100

    · Basic incident command system for initial response ICS-200

    · CERT and incident command system 315a

    · Introduction to community emergency response team 317a

    · An introduction to national incident management system 700b

    · National prevention framework, an introduction 2500

    · WMD/Terrorism awareness for emergency responders AWR160

    · Lean Six sigma green belt -2022

    CITI program certification

    · Biomedical Research investigators Completion Date: 22-Oct-2022 Expiration Date 21-Oct-2026

    (Record ID 50911175)

    · Conflicts of Interest Date: 22-Oct-2022 Expiration Date 21-Oct-2026

    (Record ID 50911175)

    · Information Privacy & Security (for Researchers) Date: 22-Oct-2022 Expiration Date 21-Oct-2026

    (Record ID 50911175)

    TRAININGS

    Introduction to Clinical Pharmacy and Research, Medication Safety and Adverse Drug Reaction Management , Clinical Services and Interventions , Clinical Documentation, Patient-Centered Care and Patient Education , Therapeutic Drug Monitoring and Dosage Adjustment , Clinical Trials and Research Design , Development and Ethics in Hospital settings , Good Clinical Practice (GCP) and Regulatory Compliance , Quality Management System (QMS) and Regulatory Compliance, Quality Audit and Inspection, Quality Control and Data Analysis, Quality Documentation and Record Keeping ,Quality Risk Management, CAPA(Corrective and preventive actions),Good laboratory practices(GLP).

Timeline

Junior Data Analyst

cognizant Technology Solutions
02.2021 - 07.2021

Clinical Data Coordinator

Moksha Biosciences
07.2020 - 02.2021

Clinical and Hospital pharmacist

Care Hospitals
07.2019 - 07.2020

Cellular Pharmacology And Toxicology, Biokinetics/Biodynamics, Research Techniques, Laboratory Management, Pharmacogenomics, Effective Scientific Writing, Clinical Investigation Capstone, Introduction To Pharmacology, Cell Biology, Biochemistry, Six Sigma Green Belt, Lab Safety, Clinical Research Roles And Responsibilities -

Wright State University

Cell Culture Training, Human Studies Research, Microbiology, and Immunology, Pharmacotherapeutics, Good Laboratory Practices, Histopathology. - Pharm D

Guru Nanak Technological Institutions (JNTUH)

Masters - pharmacology and toxicology

Boonshoft School of Medicine (Wright State University)
Sreevalli Chirumamilla