Bandana Kumari, Ph.D. Email & Phone Number

Hamilton, Ontario, Canada

Punjab, India

• Performed RT-PCR for testing or analysis on COVID-19 specimens and generated data sets.• Sourced and managed vendors needed to accomplish project goals, negotiate the best deal and best product for experimental procedure which meet hospital time lines and expertise.• Performed quality check of regulatory documents like ILC (Inter Laboratory Comparison) in accordance with the ICMR (Indian Council of Medical Research) guidelines.• Worked collaboratively with sponsor representatives on the planning, review, and finalization of the document.• Interpreted Covid-19 test results, comparison it with other published reports, compilation and generation of final report.• Planned and created timeline for the audits and review all the documents ensuring alignment with overall project timeline.• Identify area of concern with team and raised the issue with the HOD (head of the department).• Frontline Worker in COVID-19 tested lab, preparation of samples from COVID-19 patients.• Worked in BSL2 as well as in BSL3 facility.• Documentation of reagents and patient information, maintenance of data integrity.• Managed and maintained the laboratory database.As a Research Scientist at Gian Sagar Medical College and Hospital, I performed RT-PCR testing and analysis on COVID-19 specimens and managed vendors to achieve project goals. I was also a frontline worker in the COVID-19 tested lab, preparing samples from COVID-19 patients and performing RT-PCR, data interpretation, compilation, and report generation.Working in both BSL2 and BSL3 facilities, I collaborated closely with sponsor representatives on planning, reviewing, and finalizing documents. Additionally, I maintained data integrity by documenting reagents and patient information.

Mohali District, Punjab, India

• Performed analysis of clinical data (safety and efficacy) and generate clinical reports for the department.• Prepared daily COVID-19 report and maintained awareness of the performance metrics measured by the civil hospital and strived to remain within guidelines.• Send clinical reports to Civil hospital as well as to DBT (department of Biotechnology), Pune, send queries back to both the parties noted with a view to resolving and clarifying issue.• Responsible for identifying adverse events to regulatory authorities based on seriousness and expectedness, reviewing the ICMR guidelines.• Performed review and quality check of all regulatory documents.• Reviewed and interpreted clinical research data on different strains of COVID-19 from different labs.• Generated report and submitted the finalized report to the ICMR (government authority) every month. • Exhibited exceptional time management and organizational skills, consistently meeting deadlines and effectively managing project tasks.• Displayed adaptability and flexibility in accommodating project needs, aligning efforts with corporate goals and objectives. • Clinical data management and its analysis (safety, efficacy, pharmacokinetic and immunogenicity), writing SOPs, workflows, Safety Management Plans etc., Quality and Compliance assessment.• Excellent knowledge of international Regulatory guidelines.• Preparation of samples from COVID-19 patients.• RT-PCR, data interpretation, compilation, and report generation.• Collaborated with team members on project planning and execution.• Assisted in database management for research projects.• Sourced and managed vendors needed to accomplish project goals.• Frontline Worker in COVID-19 tested lab.• Update management on the status of documents and other project-related data.

Panchkula, Haryana, India

• Monitored or operated specialized equipment such as Real-Time PCR.• Developed guidelines for procedures such as the management of COVID-19 Samples and Inter-Laboratory Comparison.• Planned and conducted clinical tests and experiments in a collaborative setting.• Remotely monitored the electronic data capture system, escalating any queries or discrepancies to the team.• As a documentation lead, works closely with global cross functional teams to develop filing strategies and portfolio optimization for the molecules, leading/oversight of all filings/submissions.• Made general planning for the clinical parts.• Played an important role in NABL (an accreditation body) Audit.• COVID Sample processing, preparation, and validation.• Analyzed Real-Time PCR data and generating reports, validation and calibration of equipment.• Conducted molecular or biochemical studies and experiments.• Managed and organized laboratory databases.As a Molecular Biologist at AAL Research and Solution Private Limited, I was responsible for monitoring and operating specialized equipment such as Real Time- PCR, developing guidelines for procedures, and making general planning for clinical parts. I also played an important role in NABL Audit and were involved in COVID sample processing, preparation, and validation, analyzing Real Time PCR data, and generating reports. I was responsible for validation and calibration of equipment and planning and conducting clinical tests and experiments.

Chandigarh, India

• Under ICMR funded project "Development and evaluation of Multiplex Real-time PCR for Nesseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium, Mycoplasma hominis, and Ureaplasma urealyticum detected from patients of cervicitis and infertility."• Analysis of clinical data and generated reports/ presentation for the laboratory.• Completed target objectives of the project and submitted report before deadline.• Managed overall timelines in order to ensure compliance with internal and regulatory guidelines.• Always provided current medical information in the laboratory.• Ensured collaborative work by providing and discussing scientific data and information with the guide.• Managed and maintained research databases.• Proficiently analyze and present research reports in written as well as prepare presentations.• Skilled in garnering support and consensus for high-quality work.• Managed the trial master file in readiness for the audit.• Sample collections from OPD patients, processing of samples for DNA/RNA isolation, and performing qRT-PCR.As a Senior Research Fellow at the Postgraduate Institute of Medical Education and Research in Chandigarh, India, I worked on an ICMR funded project focused on the development and evaluation of Multiplex Real time PCR for Nesseria gonorrhoeae, Clamydia trachomatis, Mycoplasma genitalium, Mycoplasma hominis and Ureaplasma urealyticum detected from patients of cervicitis and infertility. My responsibilities included collecting samples from OPD patients, processing samples for DNA/RNA isolation, and performing qRT-PCR.

Postgraduate Diploma, Clinical Research

Activities and Societies: Clinical trials, Clinical trial Monitoring, GDP, GCP, TCPS

Ph.D, Biotechnology

Activities and Societies: Certifications: Workshop on Biorisk Management by Sandia National Laboratory, USA (2020) Multiple oral.

Master Of Science - Ms, Biotechnology, 7.5

Master of Science degree in Biotechnology and a record of certifications and publications, I demonstrated a strong foundation of knowledge.

Bachelor'S Degree, Biotechnology, 8.1

I received a Bachelor of Science degree with Honors in Biotechnology from Himachal Pradesh University in Shimla, India in March 2011. It.