SUMMARY

SKILLS

EXPERIENCE

VADLAMUDI

HARSHA SAI

KRISHNA

ad1gsp@r.postjobfree.com

737-***-****

Daytona Beach, FL 32124

Knowledgeable Clinical Research Associate with experience in documenting and assisting in clinical trials research. Clear, concise and effective written communication abilities. Thorough knowledge of FDA and GCP principles and regulations. Committed to providing support to the project team and executing responsibilities as instructed.

• Data Collection

• Action Planning

• Interactive Management

• Data Evaluation

• Research and Development

• Status Reporting

• Reviewing Data Standards

• Integrated Medical Reporting

• Project Monitoring

• Quality Control

• Patient Safety

• Detailed Documentation

• Interdepartmental Collaboration

• Clinical Documentation

• Medication Dispensing

• Narcotics Inventory Management

• Electronic Prescription Review

• Medication Distribution

• Patient Education and Counseling

• Pharmacists Support

• Insurance Verification

• Safety and Compliance

• HIPAA Guidelines

• Regulatory Requirements

• Operations Support

• Customer Service

• Patient Referrals

• Regulatory Compliance

• Monitoring and Modifying Medications

• Maintaining Patient Records

• Medication Assessments

• MEDITECH Software

• Pharmaceutical Supply Ordering

• Drug Delivery Mechanisms

• Pharmacy File keeping

• Patient Advocacy

• FDA Regulations

• Pharmaceutical Calculations

• Insurance Claim Processing Software

• Data Entry

• Hospital Staff Support

• Explaining Complex Terminology

• Laboratory Operations

• Disease Knowledge

• Verifying Orders

• Electronic Medical Records

• Critical Thinking

• Inbound and Outbound Calling

• Call Management

• Account Updating

• Appointment Scheduling

• Microsoft Office Suite

• Administrative Support

• Problem Resolution

• Professional Telephone Demeanor

• Active Listening

• High-Energy Attitude

• Adaptive Team Player

CLINICAL DATA MANAGER 06/2023 to 11/2023

US Technologies - Remote

Supported the completion of all Clinical Data Management owned deliverables in order to achieve defined business goals; Review and provide feedback on study protocols, Statistical Analysis Plans, etc.

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Proactively organize, and performed ongoing data review throughout the conduct of the study to ensure timely and appropriate identification of errors, trends, discrepancies, and quality issues.

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Generate and maintained all required documentation, including the development of specifications and validation efforts in support of annotated Case Report Forms

(CRFs), database creation, edit check procedures, import/export setup, and processing.

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• Assisted in training clinical centers on quality clinical data capture. Ensured proper closeout and archiving of data management study related materials, i.e. database change documentation, validation documents, and final patient casebooks in paper or electronic format.

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Participated in the development and maintenance of Standard Operating Procedures (SOPs)

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Provided work Instructions related to data management activities, to help build effective working relationships with team members

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QUALITY AFFAIRS SPECIALIST 11/2022 to 04/2023

Catalent Pharmaceutics Maryland - Maryland, USA

Responsible for creating deviations using Track wise for issues raised during batch record review.

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Responsible for Maintaining tracking databases, and logs associated with the batch record review.

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Initiated Quality Records and conducted deviation investigations that meets both Industry and client expectations.

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Validated data to prevent errors in manufacturing or production that could lead to product defects, Tested products extensively before their releases.

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Conducted review of master, executed batch records and ancillary documentation for accuracy and completeness, Performing final review and release of GMP manufactured products. Managed change controls, event investigations, RCA, and CAPA processes.

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Utilized QMS (veeva) to manage, and document quality processes. Conducted testing on drug product (oral solid dosage) to ensure quality and compliance.

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Supported operation teams, for MBR approval, and resolved issues with any batch records and MBRs. Managed the daily operation of the Computerized Maintenance Management System (CMMS).

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Processed document review for accuracy and completeness worked closely with the assigned End to End (E2E) team environment to ensure timely review and completion of documentation. Supported monthly e-shop floor audits for different manufacturing areas. Identified and created trend analysis for key quality performance indicators and NC/CAPA effectiveness monitoring Coordinated with Production team to discuss, resolve, and eliminate documentation observations.

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CLINICAL RESEARCH ASSOCIATE 01/2020 to 01/2021

Laurus Labs

Performed clinical research activities including protocol development, subject recruitment and data collection.

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Assessed incoming source documentation for accuracy and completeness against case report forms.

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• Provided support in writing informed consent forms, patient diaries, study manuals. Ensured timely completion of all deliverables by tracking project timelines and milestones.

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Analyzed collected data for accuracy prior to database lock; identified discrepancies when necessary.

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Maintained accurate records of all regulatory submissions, correspondence and approvals received from local ethics committees or regulatory agencies.

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• Participated in internal audits related to clinical research operations processes. CLINICAL PHARMACIST 08/2018 to 07/2019

Apollo Hospitals - Hyderabad, India

Prepared intravenous admixtures utilizing aseptic technique following USP 795 guidelines.

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Reviewed patient medical records for drug allergies, interactions, and contraindications to ensure safe medication use.

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• Dispensed medications accurately and efficiently to meet the needs of patients. Provided education to patients on proper medication usage, potential side effects, and storage instructions.

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• Collaborated with physicians, nurses, and other healthcare professionals regarding EDUCATION AND

TRAINING

CERTIFICATIONS

ACCOMPLISHMENTS

EXTRACURRICULAR

ACTIVITIES

PROJECTS

optimal therapeutic outcomes for patients.

Evaluated new prescription orders for accuracy and completeness before dispensing medications.

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Maintained a current knowledge base of pharmaceuticals through continuing education activities and literature review.

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Sacred Heart University

Ms-Healthcare informatics

06/2020

• 3.75% GPA

Sri Ventateshwara College of Pharmacy - Hyderabad, India Doctor of Pharmacy

07/2019

Percentage: 75%

Narayana junior college

Intermediate

12/2012

Percentage: 87%

Sri Chaithanya Techno School

Tenth

12/2010

Percentage: 90%

• Apollo Life Savers Program

Apollo Medskills in collaboration with National Skill Development Corporation (N.S.D.C) Government of India

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Kabaddi competition, Annual day celebrations, Sri Venkateshwara college of Pharmacy, Hyderabad, 02/01/18, First prize

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Collage competition, Pharmacist's day celebrations titled ‘Pharmacist- Your Partner in health', Sri Venkateshwara college of Pharmacy, Hyderabad, 09/01/15, First prize (team of four members)

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A group of Math and Science Talent Search examination, Little Champs Brilliance Educational Academy, Hyderabad, 11/01/10, 92nd State rank among 10,000

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Community service program - medical camp at Tholkatta village, Moinabad, Surabhi educational society, Hyderabad, 12/01/18 Exhibited a painting ‘Tobacco use- Head and neck cancer' on ‘World No Tobacco Day' at KBR park, Hyderabad, 05/01/18 Promoted awareness about Tuberculosis in the community by hosting a flash mob dance and scripted lyrics for most popular Telugu song, Apollo Hospitals and RNTCP Telangana branch, 03/01/18, https://www.youtube.com/watch?v=5t31IXss9J8 Visited Sivananda Rehabilitation home, Kukatpally for Leprosy patients, distributed medicines, Surabhi educational society, Hyderabad, 12/01/16 Took part in an initiative of 'Swachh Bharat Abhiyan' a nationwide campaign in India- Clean up the streets, roads of India's cities, towns and rural areas, Sri Venkateshwara college of pharmacy, Hyderabad, 03/01/14

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A study of risk factor assessment and treatment outcomes in Tuberculosis patients. 01/01/18, 07/01/18, Capture patient demographics, category of treatment and treatment outcomes of TB patients registered under DOTS and comparing them with RNTCP REPORT 2016 and to follow up for their treatment course completion and relapse if any., Report the success rate of the patients undergone the treatment.

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TRAINING

LANGUAGES

Antimicrobial Stewardship (ASP), Beloitt Health system, Dr. Vijaya Somaraju, Medical Director of Infectious Diseases, 12/01/18 Updates on TB Control: Strategies for a TB free India, Sri Venkateshwara College of Pharmacy in association with IPA, Hyderabad, 03/01/17 New insights of Pharmacoepidemiology and Pharmacoeconomics, Chalapathi Institute of Pharmaceutical Sciences in collaboration with University of Maryland Eastern Shore of Pharmacy, USA, 02/01/17

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English, Telugu, and Hindi.

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