Clinical Research
Resume:
NIRMAL JOSHI
CANADA
********@*******.***
OBJECTIVE
To obtain Clinical Research Associate position with your Research Team
PROFILE
• Bachelor of Science degree in Chemistry and Post Graduate Diploma in Clinical Research
• Comprehensive knowledge of GCP-ICH
• Strong understanding of FDA, HC, and ICH regulations and their applicability in Clinical Research
• Familiarity with all monitoring and coordinating responsibilities for all drug phases I – IV
• Able to follow, implement, write, and review SOPs and other clinical research documents such as: ICF, protocol, reports, and regulatory documents
• Familiarity with Auditing Clinical Trials
• Over 14 years of experience in development and drug marketing, including experience in Post Marketing Surveillance of products like Lisinopril, Omeprazole, Cisapride, Cetrizine
• Proficient in using computer programs as Microsoft Word, Excel, Access and power point
• Strong attention to details, good organizational skills, resourceful and self- motivated with good problem – solving ability
• Effective mentoring skills with the ability of working independently or within a team under pressure and meet deadlines
• Strong customer focus and excellent interpersonal skills
RELEVANT SKILLS AND EXPERIEANCE
CRA Candidate
• Academy of Applied Pharmaceutical Sciences, Toronto Sep2008 – Apr2009
• Designing, Preparing and Reviewing IB, informed consent form and protocols
• Knowledgeable in, Data collection, management resolution, and AE/SAE reporting
• Familiarity with cost estimating and resource allocation, as well as planning of investigator’s meeting for clinical research
• Knowledgeable in all coordinating activities
• Ability to perform all monitoring activities for drug Phases I – IV
• Knowledgeable in site placement, site intiation and site close-out activities
• Studying and reviewing site related documentations in adherence to GCP, SOP regulatory requirements and guidelines
BANNER PHARMACAPS (CANADA) LTD
Machine Operator AUG 2006 – SEP 2008
• Manufacture of soft gelatin capsules
• Machine operation, ribbon and capsules check (thickness, weight, seams), drying post production work and packaging
• Audit six line production
• Writing, reviewing SOP
• Cleaning and sanitization of equipments for same product to different batch product
• Planning for batch and raw material procurement and Maintaining documentation
TORRENT PHARMACEUTICALS
Field Manager AUG1990 – JUL 2003
• Targeted marketing to pharmacist / doctors in assigned territory
• Performed Post Marketing Surveillance on products like Lisinopril, Omiprazole, Cisapride, Cetrizine
• Communicated with doctors on various new products presented them with scientific data, literature and product monograph
• Develop sales plans with other sales associates to generate further sales
• Analyzed, track report on new marketing and business development strategies
• Measured, monitored and reported on sales activity on a regular basis
• Motivated and trained staff to ensure superior customer service by resolving complex customers issues in timely manner
• Discussed drug product efficacy and side effects with doctors
OTHER EXPERIENCE
Canadian Tire Corporation
Customer service representative/cashier Oct2003 – Aug2006
• Provided unsurpassed service to customers
• Maintained cash register by processing debit and credit transaction
• Work in alliance with all relevant store policies
EDUCATION
Post graduate diploma in Clinical Research
• Academy of Applied Pharmaceutical Sciences Toronto Sept2008 – Apr2009
• Applied pharmaceutical science technology SENECA Toronto 2004-2006
• BSc Bombay University 1987
REFERENCE
Available upon request
Contact this candidate