Zahra Nensi

Dear Hiring Manager,

I am excited to learn about the Clinical Research Associate position available at AstraZeneca GmbH. With a strong background in clinical research, regulatory affairs and project coordination, I would love to contribute to a company which is recognised for innovative medicines and improving patient outcomes globally.

My work experience has given me strong organizational, communication and analytical skills which are vital for monitoring and ensuring GCPs, protocols and regulatory requirements are abided by. I have experience reviewing documentation, coordinating with across and within teams and supporting quality standards throughout the clinical research process.

In addition to my experience in clinical research, I have developed excellent relationships with diverse health care professionals. I am detail-oriented and a multi-tasker. I would love to have the opportunity to contribute my passion for clinical research to your organization.

Thank you for considering my application. I look forward to hearing from you and to discuss how I can contribute to AstraZeneca Gmbh.

Sincerely,

Zahra Nensi

Jun 2018 – PRESENT ACUPUNCTURIST

True Life Wellness and Physiotherapy; North York, Ontario

• Consulting, Diagnosing and Treating patients with internal diseases and external diseases
• Creating reports from initial to follow-up
• Answering calls from patients and addressing their needs
• Generating marketing strategies to increase sales

Jan 2010 – Nov 2024 ASSISTANT MANAGER

Sherwood Copy; Mississauga, Ontario

• Hiring, managing and training staff
• Delegating tasks to employees
• Handling accounts receivables and payables
• Handling customer queries

Feb 2009 – October 2009 PROJECT MANAGER

Pharma Medica Research Inc.; Mississauga, Ontario

• Scheduled upcoming bio studies
• Developed contracts and quotes for upcoming bio studies
• Communicated with various clients on the status of bio studies
• Liased with Regulatory Affairs, Clinic, Laboratory, Quality Assurance, Pharmacy and Accounting to ensure deadlines would be met
• Resolved queries from clients as well as other departments

Jan 2006 – November 2006 CLINICAL RESEARCH ASSOCIATE (contract)

GlaxoSmithKline; Mississauga, Ontario

• Managing and monitoring Oncology, Urology clinical trials in order to ensure site investigator and study personnel are conducting the study according to protocol
• Monitoring studies according to Good Clinical Practice (GCP) guidelines and regulatory requirement
• Resolving queries from site personnel
• Ensuring identifying, reporting and follow-up on all safety information
• Training site personnel on protocols, study requirements, GCP guidelines and investigator obligations
• Updating clinical trial databases, and managing relationship with site personnel

May 2004 – Jan 2006 CLINICAL RESEARCH ASSOCIATE

Lorus Therapeutics; Toronto, Ontario

• Focused on Oncology (Pancreatic Cancer) related clinical trials (Phase 3)
• Managed and monitoring clinical trial sites in Canada and US
• Ensured clinical sites are following GCP and ICH guidelines
• Ensured reporting and follow-up on all safety information
• Reviewed and revising SOPs
• Prepared for NDA

April 2001 – May 2004 CLINICAL RESEARCH ASSOCIATE

Sanofi Pasteur; North York, Ontario

• Focused on Respiratory/Vaccine related clinical trials (Phase 1&2)
• Managed and monitored clinical trial sites in Canada and US to ensure study protocol is being followed
• Designed CRFs, diaries, ICFs
• Reviewed protocols
• Involved in developing strategies for designing protocols
• Reviewed and evaluated SAEs using WHOART and MEDdra
• Selected and trained sites
• Developed departmental training manual

Aug 1999 – Apr 2001 SCIENTIFIC AFFAIRS ASSOCIATE

Genpharm Inc; Etobicoke, Ontario

• Managed and monitored Bioequivalence studies in Canada and US
• Reviewed and evaluated SAEs
• Evaluated and audited study reports (clinical, validation, bioequivalent analysis, statistical analysis), EVA and PCERT
• Researched for literature on pharmacology and toxicology
• Responded to clarifaxes and deficiency letters

Nov 1997 – Aug 1999 TECHNICAL WRITER

Genpharm Inc; Etobicoke, Ontario

• Generated Test specifications for raw materials, bulk products, finished products and packaging components using USP, EU and JP Pharmacopoea
• Initiated and maintained Change Controls
• Managed work of junior level technical writers
• Mentored junior level technical writers

Apr 1997 – Nov 1997 QUALITY ASSURANCE ASSISTANT

Abbott Laboratories; Downsview, Ontario

• Tested for the quality of finished products
• Assisted Microbiology with culture swabs

1990 – 1995 University of Toronto; St. George Campus

Honors Bachelor of Science – Toxicology

Final Thesis: The Effect of Urokinase on Breast & Colon Metastasis

1995 – 1996 Seneca College; Newnham Campus

Regulatory Affairs

Pharmaceutical Microbiology

HPLC Troubleshooting

Business Management

Microcomputers

2000 University of Maryland; Baltimore, Maryland

ESD / EVA Bioavailability / Bioequivalence

Advanced ESD / EVA Bioavailability / Bioequivalence

2000 FDA Training; Toronto, Ontario

Good Clinical Practice

2002 Aventis Pasteur; Toronto, Ontario

Introduction to Project Management

Effective Writing

2003 – 2008 Athabasca University; Athabasca, Alberta

Masters Degree – Health Studies

2026 AAPS College of Health, Science and Technology

Clinical Research, Drug Safety and Pharmacovigilance