Vishalini Chalapati
Coal Valley,IL
Summary
Dedicated to using excellent research, investigation and project management abilities to optimize the management, organization and reporting of clinical data. Results-driven, precise, and systematic with quick learning and collaborative nature. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management, and problem-solving skills.
Overview
6
6
years of professional experience
1
1
Certification
Work History
Clinical Data Manager
Alexion Pharamaceuticals
05.2022 - 01.2024
- Worked on data review in support of data cleaning, and quality control for operational study data in Medidata RAVE and other EDC databases.
- Reviewed study protocol and developed a Data Management Plan (DMP) in coordination with internal and external vendors
- Coordinated with a coder for drugs, and adverse events through MedDRA and WHO Drug dictionaries.
- Developed and test edit specifications which may include the development of test scripts used for UAT testing.
- Reviewed and tested eCRFs screen design and Edit check specification for Oncology study.
- Coordinated with Clinical Data Management Staff, Client, and Study Team to identify issues/trends for discussion.
- Developed Data Transfer Agreement (DTA) between external data vendors.
- Experienced in Lab and SAE Reconciliation plans.
- · Ensure that medical coding is completed in a timely fashion, completed for all data cuts, and reviewed and approved by medical monitors.
- ·Updated slides submitted to Governor every week, for showing a report on trends of Percent sequenced samples in Tableau
- ·Worked on data review in support of data cleaning, and quality control for operational study data in Medidata RAVE and other databases
- · Responsible for the accurate development of CRFs and edit check specifications per the protocol and the
- Performed paper and electronic data entry in case report forms using EDC systems and perform database maintenance and troubleshooting.
- Designing annotated CRFs based on protocol specifications and CDISC & CDASH requirements
- Worked on database programming, medical coding, and statistical programming teams to ensure study progression.
- Contributed towards developing guidelines/checklist that aids in streamlining of activities for Data Management (DM) during study close-out.
Graduate Intern
MEMORIAL HOSPITAL
01.2022 - 05.2022
- Worked closely with nurses and certified nurse assistants to deliver effective patient care to residents at different assisted living facilities
- Acquired effective communication skills when interacting with residents, colleagues, and leaders
- Observed CRNAs and physicians during cesarean sections, colonoscopy, hip, and knee replacement surgeries, and other surgeries
- Observed preoperative interviews and preparation of patients
- Observed induction of general anesthesia, invasive line placement, regional techniques, and emergency from general surgery
- Conducted data analysis of health-related conditions to identify trends and support decision-making
- Planned and executed community health outreach events that provided free diabetic screening that led to the diagnosis of new diabetic patients
- Conduct infection prevention activities in the facility including tracking and reporting HAI events, monthly meetings, protocol training, and sampling of hospital environment/surfaces.
Graduate Research Assistant
Western Illinois University
01.2020 - 05.2022
- Completed administrative and research duties per professor request.
- Recorded data and maintained source documentation following good documentation practices.
- Performed statistical, qualitative, and quantitative analysis.
- Planned, modified and executed research techniques, procedures and tests.
- Gathered, reviewed, and summarized literature from scientific journals such as SciFinder and PubMed and produced graphs and other scientific calculations using MS Excel.
- Prepared summaries of research data for use in high-level meetings and presentations.
- Worked both independently and collaboratively in fast-paced laboratory environment.
- Attended seminars and symposiums to improve overall knowledge and understanding.
- Created surveys and questionnaires to collect data for research projects.
- Recorded experimental findings in laboratory notebook to analyze and interpret experimental findings.
- Interpreted laboratory results to provide technical advice to scientists.
- Developed new protocols and improved existing laboratory processes.
Registered Nurse
Apollo Hospitals
01.2019 - 12.2019
- Expertise in assessing patients, identifying changes in status, establishing priorities for patient care, and identifying crisis situations when needed
- Formulated nursing diagnoses by interpreting data from health team members and integrating it into written assessments
- Participate in the formation, implementation, and evaluation of team goals
- Appropriately delegates and supervises interventions to implement the plan of care
- Collaborate effectively as a key member of an interdisciplinary healthcare team, working cohesively to provide comprehensive care to patients
- Administered medications via oral, IV, and intramuscular injections and monitored responses
- Educated patients, families, and caregivers on diagnosis and prognosis, treatment options, disease process, and management and lifestyle options
- Provided direct patient care, stabilized patients, and determined the next course of action
- Managed care from admission to discharge
- Implemented medication and IV administration, catheter insertion, and airway management
- Evaluated healthcare needs, goals for treatment, and available resources of each patient and connected to optimal providers and care
- Advocated for patients by communicating care preferences to practitioners, verifying interventions met treatment goals, and identifying insurance coverage limitations.
Nursing Internship
Apollo Hospitals
04.2018 - 12.2018
- Worked alongside experienced nursing professionals to learn new procedures at Dialysis and Cath lab areas
- Administered medications and treatment to patients and monitored responses while working with healthcare teams to adjust care plans
- Monitored patient vital signs, reporting any changes to experienced nursing staff
- Performed regular rounds to check on the well-being of patients
- Administered close patient care, checked vital signs, and monitored telemetry
- Pursued continuous learning through training sessions and education to stay abreast with respective department procedures and advancements.
Education
Master of Science - Masters of Public Health
Western Illinois University
Macomb, IL05.2022
Bachelor of Science - Nursing
DR. N.T.R UNIVERSITY OF HEALTH SCIENCES
Hyderabad, India12.2018
Skills
- Protocol adherence
- Data Management & Analysis
- ICH-GCP guidelines
- Compliance with HIPAA Guidelines
- Hands on experience with CTMS tool: RAVE
- Discrepancy Management
- Immunizations
- Worked on studies in the therapeutic areas of renal disorders, respiratory disorders
- MS word, excel & outlook
- SPSS: Statistical Tool
- Knowledge in Medical Coding with MedDRA and WHO Drug
- Strong Communication & Presentation skills
- Immunization Protocols
- Intravenous therapy
- Compliance with HIPAA Guidelines Discrepancy Management
- MS Word, Excel, and Outlook
- Informed Consent
- Research Experience
- Good Clinical Practice
- Report Preparation
- Project Monitoring
- Clinical Documentation
- Protocol Development
Certification
Licensed Registered Nurse – Illinois Board of Nursing
Timeline
Clinical Data Manager
Alexion Pharamaceuticals
05.2022 - 01.2024
Graduate Intern
MEMORIAL HOSPITAL
01.2022 - 05.2022
Graduate Research Assistant
Western Illinois University
01.2020 - 05.2022
Registered Nurse
Apollo Hospitals
01.2019 - 12.2019
Nursing Internship
Apollo Hospitals
04.2018 - 12.2018
Master of Science - Masters of Public Health
Western Illinois University
Bachelor of Science - Nursing
DR. N.T.R UNIVERSITY OF HEALTH SCIENCES
Similar Profiles
Karthick Devan SarangapaniKarthick Devan Sarangapani
Territory Manager at Torrent Pharamaceuticals India LimitedTerritory Manager at Torrent Pharamaceuticals India Limited
Sabyasachi BhattacharyaSabyasachi Bhattacharya
Section Manager - Learning & Development at Otsuka Pharamaceuticals India Pvt. Ltd.Section Manager - Learning & Development at Otsuka Pharamaceuticals India Pvt. Ltd.
Devin GunasekaraDevin Gunasekara
Associate Director, Global Strategic Sourcing at Alexion, Astra Zeneca Rare DiseaseAssociate Director, Global Strategic Sourcing at Alexion, Astra Zeneca Rare Disease
Daniel ZehrDaniel Zehr
NOC Technician at Geneseo CommunicationsNOC Technician at Geneseo Communications
Svea CarlsonSvea Carlson
Lifeguard at Riverside RiverslideLifeguard at Riverside Riverslide