Bharti Kachela

Background:

2 Yr of experience as a CRA2, One and half year of experience as a CRA 1 in Research and Development domain, 5 years' experience of Medical writing in National and international journals e.g. research papers, articles, blogs, concept papers writing, thesis writing and health policy briefs.

Having more than 11 publications in International journals including discovery, Taylor Francisco journals etc. Also, equipped with job experience in Clinical and Hospital pharmacy practices in Oncology, Qualitative and Quantitative Research Assistance in Public health services and epidemiology and Medical affairs in pharmaceuticals. Seeking to leverage Senior CRA chore resposibilities, project management skills and working across different functional lines of global research market.

Clinical Trial Experience

IQVIA and its Affiliated Companies Clinical Trial Experience:
1.Study Phase: Phase 3
Indication: COVID-19
Special Population: Elderly
Drug Class: Vaccines - Antiviral
# of Patients: 218
Role: Clinical Research Associate I
Key Responsibilities: Performed site initiation, monitoring and close-out visits in accordance with
contracted scope of work and good clinical practice, wrote all monitoring
reports and Follow up letter to keep up good documentation practice.

2. Study Phase: Phase 3
Indication: Viral hepatitis D
Special Population: Elderly
Drug Class: Small Molecule (Kinase Inhibitor)

# of Countries: 21
# of Sites: 127
Role: Clinical Research Associate

Key Responsibilities: Responsible for Co-monitoring at site in Pakistan and for close-out visits as
well,
in accordance with contracted scope of work and good clinical practice.
Support
work with sites to adapt, drive and track subject recruitment plan in line with
project needs to enhance predictability.

3. Study Phase: Phase 3
Indication: Viral hepatitis D
Special Population: Elderly
Drug Class: Small Molecule (Kinase Inhibitor)
# of Countries: 21
# of Sites: 127
Role: Clinical Trials Assistant
Key Responsibilities: Performed Clinical Trial Assistance in term s of maintaining Clinical trial file
and regulatory documentation in accordance with contracted scope of work
and good clinical practice. If
applicable, Also. Supported
work with sites to adapt, drive and track subject recruitment plan in line with
project needs to enhance predictability.

4. Study Phase: Phase 2
Indication: Ulcerative Colitis
Special Population: Elderly
Drug Class: Gastrointestinal Agents

# of Countries: 5

# of Sites: 148
Role: Clinical Research Associate
Key Responsibilities: Performed site selection, initiation, monitoring
in accordance with contracted scope of work and good clinical practice. Also I
was accountable for
development of project subject recruitment plan on a per site basis. Support
work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.

5. Study Phase: Phase 2
Indication: COVID-19
Special Population: Elderly
Drug Class: Biologic (Antibody)
# of Countries: 4
# of Sites: 23

Role: Clinical Research Associate
Key Responsibilities: Responsible for pharmacy visits as an Unblinded CRA, to maintain the IP accountability and documentation in accordance with contracted scope of work and good clinical practice.

6. Study Phase: Phase 2
Indication: COVID-19
Special Population: Elderly
Drug Class: Biologic (Antibody)
# of Countries: 4
# of Sites: 23
Role: Clinical Trials Assistant
Key Responsibilities: Responsible for Clinical trail and regulatory documents maintenance
in accordance with contracted scope of work and good clinical practice.

7. Study Phase: Phase 3
Indication: COVID-19
Special Population: Elderly
Drug Class: Vaccines - Antiviral

# of Countries: 1
# of Sites: 1
Role: Clinical Research Associate I
Key Responsibilities: Remote Monitoring of site in Phillipines

8. Study Phase: N/A
Indication: Typhoid Fever
Special Population: Minors
Drug Class: Vaccines - Antibacterial
# of Countries: 1
Role: Clinical Research Associate I
Key Responsibilities: Responsible for Monitoring of documentation and data.

9. Study Phase: Phase 3
Indication: COVID-19
Role: Clinical Research Associate II
Key Responsibilities: Performed SSV for AKUH and Indus hospital in Karachi, Pakistan

10. Study Phase: Phase 3
Indication: COVID-19
Role: Clinical Research Associate II
Key Responsibilities: Performed SSV for two sites, AKUH and Indus hospital, located in Karachi,Pakistan

11. Study Phase: N/A
Indication: Eyelid finding
Role: Clinical Research Associate II
Key Responsibilities: Performed SSV for site AKUH and proceeding towards regulatory submission
in order to proceed towards SIV

12. Study Phase: Phase 3
Indication: Arthritis
Role: Clinical Research Associate II
Key Responsibilities: worked as a CTA for this study site located in Malaysia

13. Study Phase: Phase 2
Indication: Malignant Tumor of Lung
Role: Clinical Research Associate II
Key Responsibilities: worked as a CTA for this study site located in Singapore

14. Study Phase: Phase 3
Indication: Malignant Tumor of Lung
Role: Clinical Research Associate II
Key Responsibilities: worked as a CTA for this study site located in Malaysia

13. Study Phase: N/A
Indication: Influenza
Role: Clinical Research Associate II
Key Responsibilities: SSV done, proceeding towards start up phase

15. Study Phase: Phase 3
Indication: COVID-19
Role: CRA 2
Key Responsibilities: Site Monitoring, Documents management, site and study team communication, Site staff training

16. Study Phase: Phase 3
Indication: COVID-19
Role: CRA 2
Key Responsibilities: Site Monitoring, Documents management, site and study team communication, Site staff training

17. Study Phase: Phase 3
Indication: Macular Degeneration
Role: Clinical Research Associate II
Key Responsibilities: Site Monitoring, Documents management, site and study team communication, Site staff training

18. Study Phase: Phase 3
Indication: Non-Small Cell Lung Cancer
Role: Clinical Research Associate II
Key Responsibilities: Site Monitoring, Documents management, site and study team communication, Site staff training

Publications, Doctoral Thesis (selected items):

 “Estimation of direct cost of managing rheumatoid arthritis treatment to Pakistani patients using realworld follow-up data”

 Assessment of patient satisfaction following Pharmacist counseling session by a novel patient satisfaction feedback on counseling questionnaire.

 Development and validation of novel rheumatoid arthritis knowledge assessment scale (RAKAS) in Pakistani rheumatoid arthritis patients.

 Translation and validation of English Version of General Medication Adherence Scale (GMAS) in patients with chronic illness.

 Dietary supplement use among students of Pharmacy College in the city of Karachi, Pakistan: Prevalence, Opinion and Attitude.

 Article Publication regarding detailed account of Heat stroke.

 Research article Publication regarding assessment of medication adherence and knowledge regarding the disease among ambulatory patients with diabetes mellitus in Karachi, Pakistan.

 Research article publication regarding evaluation of drug dispensing particles by Pharmaceutical drug retailer in Karachi, Pakistan.

 Research article publication regarding in appropriate drug therapy with life threatening interaction between Ropinirole and Quetiapine in Parkinson's disease.

 Article about, "what does it mean to be healthy"?

 Article about "5 ways to be a more empathetic friend".

 Reflexivity upon Reality, Perception, Paradigm and Paradigm shift.

Other Relevant Information Licenses and Certifications

 Certificate for participation in psychiatry and pathology oral presentations/posters on 7th symposium of Liaquat national hospital and Medical College., 2017

 Certificate for participation in symposium Pharmacist: A need of health care system organized by Ziauddin College of Pharmacy., 2015

 Certificate for participation in the Seminar entitled Nanotechnology Science, Medicines application organized by Ziauddin University., 2014

Attended the pre-conference workshop entitled Epidemiology and Biostatistics in 1st International conference on Endorsing Health Sciences research organized by AEIRC., 2014

 Attended the pre-conference workshop entitled Basic Tools for Clinical Research in 1st International conference on Endorsing Health Sciences research organized by AEIRC., 2014

 Attended the conference entitled 1st International conference on Endorsing Health Sciences research organized by AEIRC., 2013

 Certificate for participation in the Seminar entitled Stability studies of drugs and formulated products organized by Ziauddin University., 2014

 Certificate for participation in the Symposium entitled Clinical Pharmacy Practice-An era of transition from theory to practice organized by Ziauddin University., 2014

 Certificate of presentation by AEIRC institute for presenting poster entitles Dysmenorrhea in relation with hygiene; a study on symptoms and prevalence., 2014

 Certificate of achievement by Injaz Pakistan for successfully completing Head start: Boosting your employability. HONORS & AWARDS., 2013

 Biomedical Responsible conduct of Research Certification by CITI Program., 2018

 Thesis: Living with chronically mentally ill patients; caregiving experiences of primary caregivers., 2019

 Thesis: Growing public cognizance or perception regarding cervical cancer., 2015

 Successfully Completed Dysmenorrhea research at AEIRC., 2016  Provided Volunteer Service for 20 hours at Darul-Sukun Hospital Karachi., 2014

 Cost evaluation and Analysis project at Aga Khan University., 2019

 CCRP: Certified clinical research professional certification (In progress), 2019

 Spotlight Award by IQVIA for CLOVER Study, 2021

 Ovation award by IQVIA for UC study, 2021

Relevant Non-Clinical Training: Trainings related data security and work ethics. cc