Clinical Research Associate
Resume:
SHAFIQUE AHMED KIANI
Scarborough, M1P 2H3
Email: *********@*****.***
Objective: Clinical Research Associate.
Highlights of Qualifications
• Four years Research Coordinator experience in Rawalakot university, Pakistan
• Sound knowledge of Clinical Monitoring process in accordance to ICH, FDA, HC and regulatory requirements and guidelines
• Detailed knowledge of GCP-ICH guidelines including basic knowledge of regulatory requirements
• Familiar with monitoring and coordinating responsibilities for all drug phases I-IV
• Demonstrate competencies in managing clinical trials data, formulating source documents and data collection charts and adverse/severe adverse event reporting
• Comprehensive knowledge of Data Collection, Management and Resolution
• Ability to review SOPs, and other clinical research documents such as ICF,Protocol,reports and other regulatory documents
• Proficient in Clinical Trial Supplies Management, including drug accountability
• Sound knowledge of life science subjects and medical terminology
• Familiar with Auditing Clinical Trials
• Extensive knowledge of histological study of animals for different pre-clinical research projects
• Excellent computer skills including Microsoft office (Word, Excel, Internet, Email)
• Possessed remarkable ability to work and make independent decision, understand complex medical information, and able to take the initiative to lead projects and assignments
• Sound ability to coordinate and motive independently
Relevant Work Experience
CRA Candidate
Academy of Applied Pharmaceutical Sciences, Toronto 2008-2009
• Comprehensive knowledge of GCP-ICH
• Strong understanding of FDA,HC,ICH guidelines and their applicability
• Ability to write and review of SOPs,Protocols.ICF,Regulatory documents, monitoring reports and other clinical trial documents
• Knowledgeable in monitoring clinical trial source documentation, regulatory binders, drug accountability and queries generated by data management
• Competent in the planning ,organizing and management of Clinical Trials
• Ability to perform all monitoring activities for drug phases I-IV
• Good comprehension of the process of data acquisition, management and resolution
• A good understanding of informed consent process
• Familiarity with auditing of clinical trials
• Extensive knowledge in all coordinating activities
SHAFIQUE AHMED KIANI 647-***-**** Page 2
Research Coordinator
Rawalakot University, Pakistan 1999-2004
• Performed experimental procedure on rodents, including cell and tissue isolation
• Performed histological techniques including tissue fixing,embedding,sectioning and immunostaining
• Reviewed, analyzed and entered data collected at research sites
• Prepared final reports and manuscripts for publication, presented data and findings in scientific meetings/conferences
• Ordered and maintained the records of supplies and equipment to research site and university lab
• Operated standard laboratory equipment such as microscope,centrifuge,spectrophotometer,Incubator and balances
• Maintained and provided guidance to the students who were preparing for research work and thesis on Biology Research Projects
• Conducted various courses including Cell Physiology, Pharmacology, and Genetics
• Taught university courses regarding Cell Science and Biology subjects and publish their finding and performed works of art
Head of Biology Department
OPF College for boys, Islamabad, Pakistan 1995-1999
• Overall management responsibilities for the department
• Coordinated Teaching and Administration matters
• Organized academic course schedule and coordinated course curriculum
• Developed and wrote informative teaching material on biology and supervised students
• Monitored project activity, schedule training visits, and maintain training records
Other Work Experience
Security Guard
Accord Security & Investigation Inc, Scarborough 2005–2008
• Guarded industrial and commercial properties for different client companies against fire, theft, vandalism and illegal entries
• Prepared written reports of incidence and communicate with supervisor to solve the issues
• Ability to conduct safety audits and verify to compliance with policies
Educational Qualification
Post Graduate Diploma in Clinical Research, AAPS, Toronto 2008- 2009
Master in Biology (ICAS equivalency) Quaid-e-Azam University Pakistan 1993- 1995
Diploma in Homeopathic medicine Pakistan 1987- 1990
References Available upon request
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