Clinical Research Data
Resume:
SHIVALI S. JOSHI, Ph.D. *************@*****.***
***-**** **** **. **, Calgary, AB T2N4M1
Canada [Relocating to Vaughan, Toronto in Feb 2020] SUMMARY:
• Pleasant and dedicated individual with an expertise in infectious diseases and vaccines working in a GLP and GCP environments.
• Experienced in drafting ethics applications, consenting study participants and patient partners to various clinical trials.
• A proven record of time management and working in high volume settings dealing with clinical samples (Hepatitis B virus, Hepatitis D virus, HIV, non-alcoholic fatty liver disease) and data.
• Experienced in verification and validation of clinical assays for industry following SOPs.
• Strong managerial and leadership qualities with experience in training lab personnel (scientific guidance and formal biosafety training), organizing lab and departmental weekly research meetings involving > 50 scientists (includes creating a bi-annual presentation schedule for the team) and managing reagent inventories.
• Excellent written and verbal communication skills demonstrated through 10 scientific manuscripts, grants and >25 presentations (oral and poster) in national and international conferences.
EXPERIENCE:
Post-doctoral fellowship
University of Calgary, AB, Canada 2016 - present
• Discovered that in obese individuals with a fatty liver, vaccine efficacy is significantly compromised. This led to renewal of a grant, collaboration with a Spanish university and publications.
• Performed on strict timelines, ultrasensitive diagnostic testing on samples from various industry sponsored clinical trials, analyzed data and communicated results internally and to the industry.
• Team player serving as an in-lab mentor to a team of lab technicians (5), undergrad trainees
(10), graduate students (4), clinical and post-doctoral fellows (4).
• Optimized reagent inventory and lab usage by organization and internal/external communication, leading to cost saving of CAD10,000 per year.
• Managed and organized a biobank – repository of > 1000 biological specimens (human).
• Disseminated subject matter knowledge and research findings in different formats (posters, publications and oral presentations) to a variety of audience ranging from undergraduate students (didactic teaching), one-to-one – lab mentor and group settings (local seminars, research updates and national and international conferences).
• Developed protocols for investigator initiated clinical trials with cross functional teams with internal/ external communication.
• Proven ability to multi-task – worked simultaneously on 6 diverse projects resulting in abstracts, manuscripts, presentations, posters and generation of new projects for the team. Ph.D. fellowship 2009-2016
National Institute of Virology,
Pune university, India
• Independently conducted a pre-clinical study evaluating the role of adjuvants in modulating vaccine response to a novel recombinant hepatitis E vaccine candidate during pregnancy in 2 mice models.
• Gained experience in literature and product search (proteins, antibodies, endotoxin detection kits, ELISA kits etc.), experimental design, execution, troubleshooting and data analysis.
• Trained 5 research assistants on standard laboratory protocols and mentored 1 graduate student.
• Regularly wrote quarterly and annual research reports for submission to institute and university. EDUCATION:
• Ph.D. (Biotechnology) 2009-2016
National Institute of Virology
Pune university, India
• Masters of science (M.Sc.) in Biotechnology 2007-2009 University of Mumbai, India
• Bachelors of science (B.Sc.) in Biotechnology 2004-2007 University of Mumbai, India
RELEVANT COURSES UNDERTAKEN:
1. Leadership in Patient-Oriented Research – Pragmatic Clinical Trials Certificate, January 2020 2. Clinical Research Co-ordinator (CRC) by CITI Canada (record ID: 33147729). 3. FOIP: Focus on privacy by Government of Alberta, September 2019 4. Canadian Good Clinical Practices (GCP) by CITI Canada (record ID: 33147723) 5. Health Canada Division 5 by CITI Canada (record ID: 33147728) 6. HIA Awareness by Alberta Health Services, September 2019 7. TCPS 2: Core by Tri Council, Canada, August 2019 AWARDS AND RECOGNITION:
• International HBV meeting 2019 travel award ($ 1500).
• International HBV meeting 2017 travel award ($ 1000).
• Commendation received from the National Molecular Virology Meeting 2013 for co-organizing speaker and attendee logistics at National Institute of Virology, India.
• Indian Council of Medical Research (ICMR) PhD fellowship (2009-2016). Awarded to top 100 candidates out of >5000 applicants.
• Council of Scientific and Industrial Research (CSIR) fellowship award 2009 and lifetime validity lectureship to Bachelors and Masters (Life sciences) students. All India rank 101 ( ~10000 applicants in total).
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