ARUNA MAMILLAPALLI
Orlando,FL
Summary
- As a CRA initiated the trial from subject enrollment as a data entry person in CDMS like RAVE and always adhering to protocol guidelines and ethics.
- Continues monitoring of the subjects for any ADR'S, SAE with proper documentation and reporting on daily basis.
- Worked closely with PI and CRC to coordinate and maintain the Clinical study as per GCP Guidelines.
- Experienced Quality Control Analyst with demonstrated track record of improving products and procedures by leveraging hands-on inspections, testing methods and data analysis. Disciplined professional with systematic approach to completion of work order. Applies excellent attention to detail and critical reasoning to successfully conduct experiments.
- Expertise in handling different databases including Medidata Rave.
Overview
4
4
years of professional experience
1
1
Certification
Work History
QUALITY ASSURANCE
DECIBEL CANNABIS COMPANY
01.2022 - 08.2022
- Creating work orders, verifying the work orders and releasing it to the production team for the making of the products.
- Supported continuous improvement efforts by actively participating in process reviews and suggesting data-driven recommendations for enhancement.
- managed 10-15 WO in a day with great multitasking collaborating with teams
- Performed swab tests for the production technicians and the production rooms before the WO set up.
- Intermittent and consistent checking the proper documentation from different teams collaborated with the WO.
- Played a key role in new documentation for different teams by providing insightful feedback on prototypes and guiding design revisions.
- Reduced defects in production by consistently reviewing processes and collaborating with cross-functional teams especially with the large WO when there reprinting of labels.
- Generated quality control reports for returned products to identify and communicate patterns.
- Assessed quality of finished products with careful inspections, by checking each and every detail of WO numbers, LOT numbers,child LOT numbers etc by checking the labels printed.
- verifying the terpenes values from the referral documents and verifying with the values on the products being worked.
- Evaluated and analysis the returned products by conducting the appropriate tests for safety, functionality, and other issues.
- Educated employees of production technician's on specific new QA standards, documents and confirmed maintenance of proper documentation for ongoing and future work orders.
- Documented and updated all the WO on daily basis in wage as per standards followed for the delivered orders.
- Maintaining the proper timelines by checking the orders on priority basis.
CLINICAL DATA ASSOCIATE
ACENTUS INFO SOLUTIONS PVT LTD
11.2020 - 12.2021
- Worked on data validation, query management, issuing and closing queries, and met TAT as per study requirements.
- Worked on Query reports to find the query trends in the project. Conducted in-house data review and escalated data issues to Lead Manager.
- Worked on Query tracker, ongoing Issues tracker with lead data manager.
- Reviewed and assisted to annotate CRF'S in accordance with the specifications
- Performed database checks and ensured studies are in accordance with the protocol
- Ensured GCDMP guidelines are followed in every data management activity.
- Update CDM control documents, including SAE reconciliation, Laboratory / PK reconciliation plans, etc
CLINICAL RESEARCH ASSOCIATE
GENSOL INFOTECH PVT LTD
09.2018 - 10.2020
- Conducted initiation, monitoring and closeout visits to verify study protocols, procedures, regulatory documents and data completion.
- Conducted clinical trial in accordance with protocol and recorded and monitored progress.
- Applied extensive knowledge to troubleshoot and resolve regulatory document issues by proper data verification.
- Managed multiple projects simultaneously while maintaining high level of attention to detail and meeting deadlines.
- Observed clinical studies and assessed health outcomes in groups of participants in next visits to support research plan.
- Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
- Promoted awareness of project-specific quality and performance standards to support documentation from EDC communicated with DM for any assistance and understanding.
- Collaborated with cross-functional teams to successfully meet project timelines and deliverables by answering the queries within the time.
Education
DOCTOR OF PHARMACY (PHARMA.D)
ACHARYA NAGARJUNA UNIVERSITY
GUNTUR,INDIASkills
PROFESSIONAL SKILLS
- ICH-GCP Guidelines
- CLINICAL RESEARCH AND CLINCIAL PHASES
- PROTOCOL AND ICF
- Sound Knowledge on PROTOCOL AND DMP
- Familiar with roles and responsibilities of sponsor,investigator,IRB/IEC
- Medidata Rave X
- Database Design
- Data Validation,QC,QA skills
- Data Review and UAT
- SAE and LAB Reconciliation
- Medical terminology
SOFT SKILLS
- Team work
- Planing
- Coordination
- Time management
- Multi tasking
- Attention to details
- Decision Making
- Good communication
THERAPEUTIC AREAS
- Cardiac (HTN'S)
- Diabetes
- COVID-19 Studies
CLINCAL PHASES
- Phase 1
- Phase 2 (predominantly)
- Phase 3 (predominantly)
- Phase 4
Accomplishments
REVIEW ARTICLE
- Review on ethical concerns in Placebo stuides.
Certification
- Good clinical Practice(GCP)-National Institutes Of Health(NIH).
Timeline
QUALITY ASSURANCE
DECIBEL CANNABIS COMPANY
01.2022 - 08.2022
CLINICAL DATA ASSOCIATE
ACENTUS INFO SOLUTIONS PVT LTD
11.2020 - 12.2021
CLINICAL RESEARCH ASSOCIATE
GENSOL INFOTECH PVT LTD
09.2018 - 10.2020
DOCTOR OF PHARMACY (PHARMA.D)
ACHARYA NAGARJUNA UNIVERSITY