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OPPORTUNITIES IN CLINICAL RESEARCH
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OPPORTUNITIES IN
CLINICAL RESEARCH
Agenda
Introduction to Clinical Research The Industry Opportunity Career Opportunities Eligibility About Us About the Programs Contact Us
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What Is Clinical Research?
Clinical Research is the research done on humans for new medicines or improved versions of old medicines, with the aim of studying their safety, efficacy, dosage and delivery systems.
Clinical Trial in the Drug Development Process:
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Clinical Research Overview
• Clinical Research is a process of testing the safety and efficacy of drugs by monitoring their effects on a large group of people.
• Once the trials are completed, the FDA approves the drugs and only then pharmaceutical companies manufacture or market the drugs.
• The cost of bringing a single drug to market can exceed US$1 billion, which implies the growth of clinical research market.
4Clinical ResearchClinical Research
Industry Opportunity
Rapid increase in investment on clinical research & drug development • Annual industry revenue to double from $11b to $23b globally in next 5
years (www.clinpage.com; Frost report on CROs, Sep’09)• Patents for most top selling drugs are expiring in 2010, creating an
immense need for pharmaceutical companies to invest in R & D. • Over 100k registered trials globally (clinicaltrials.gov – Dec, 2010)
USA 36.8%Canada 5.5%Germany 4.6%France 4.0%United Kingdom 3.5%Italy 2.6%Spain 2.3%Netherlands 2.2%Belgium 2.0%Australia 2.0%
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Industry Opportunity
Increasing demand for clinical research professionals• Projected 30k job openings from 2008 to 2018 (Bureau of Labor Statistics
2008-2018 employment projections)
• Less than 3% of 2,000 health science colleges in USA offer clinical research courses. (National Centre for Education Statistics College navigator)
Potential markets globally• Europe: Second highest number of trials in the world (over 25% of total trials
happen in Europe) (Source: www.clinicaltrials.gov, 2010)
• Canada: Lack of formal education programs & regulated activity (Clinical Research in Canada, 2 Mar 2009 http://learnclinicalresearch.ca )
• India: Clinical trial market forecast to grow at a CAGR of around 31% during 2010-2012 (Budget Incentives to Boost Indian Clinical Trial Market, 23 Mar 2010 http://www.pr-inside.com )
• China: Clinical trial market revenues to continue double digit growth from 2010 through 2020. (Clinical Trial Strategies for Small Pharma http://www.pharmafocusasia.com )
Recession-Proof• Drug development and investments in development of new drug molecules will
continue to increase, despite the economy. This translates into more opportunities in clinical research.
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Industry Opportunity
• The clinical research industry has been responsible for bringing numerous careers to the forefront for healthcare professionals.
• Professionals involved in direct patient care are taking the opportunity to transition from standard clinical care to roles within the clinical research industry.
• The Clinical Research Associate (CRA) role has become a very popular and sought after career option for nurses.
• Doctors/ Nurses are now expanding their career into clinical research roles such as Principal Investigators, CRAs and Medical Monitors.
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Global Demand
As of December 2010, there are over 100,000 FDA registered clinical trials in about 174 countries across the globe.
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Why Choose This Career?
• Doctors/physicians/nurses/pharmacists who conduct clinical trials:– get first hand experience with the most recent drugs– get global recognition working on the same platform as other
international experts on the project– get an opportunity for publication in journals– have access to the latest medicines for their patients
• People who entered clinical research climb the ladder toward managing trials reasonably quickly.
• Clinical Research is a field that takes you beyond the desk or lab jobs, and offers plenty of career prospects.
• In Clinical Research, the learning curve for professionals and the deployment time into the job market is smaller as compared to other fields.
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Career Opportunities
Tremendous career opportunities in the industry Lucrative salaries Excellent growth prospects International exposure and prospects
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What Does A CR Do?
A clinical research (CR) professional:•Oversees the whole process of a clinical trial •Ensures scientific integrity, accurate data flow and analysis in accordance with regulatory authorities•Protects rights, safety and well being of volunteers.
Clinical research professionals draw highly competitive salaries depending on skills and experience.
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Industries You Work In
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Career Tracks
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Clinical Research Principal Investigators Data Management Quality Assurance/Control
Project Manager
Senior CRA
CRA I, II and III
Clinical Site Monitor
Medical Monitor
Co-Investigator
Project Manager
Data Manager
QA/QC Manager
Regulatory Specialists
Data Analyst
Study Designers
Clinical IT
Technical Writers
QA/QC Auditors
Drug Safety Officer
Clinical Trial Assistants
Biostatisticians/SAS Developers
Data Coordinators
Clinical Research Coordinator
Salary Ranges
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Low HighClinical Research Coordinator 41,291 72,865Clinical Research Associate I 45,364 68,057Clinical Research Associate II 56,159 87,176Clinical Research Associate III 67,790 106,700Drug Safety Associate 61, 368 86,090Drug Safety Specialist 62,355 90,625Drug Safety/Medical Information Specialist I 46,571 70,093Drug Safety/Medical Information Specialist II 53,205 80,539Drug Safety/Medical Information Specialist III 48,648 102,397Drug Safety/Medical Information Specialist IV 76,871 123,897Medical Offi cers 125,663 295,684Medical Liaison 92,419 126,406Study Manager 101,620 132,942Biostatisticians I 50,438 85,319Biostatisticians II 73,833 113,696Biostatisticians III 90,476 135,883Biostatisticians IV 123,691 157,142
Typical Salary Range in US$Job Title
Source: www.salary.com, www.payscale.com, www. hotjobs.yahoo.com/salary
Salary Ranges (Contd.)
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Low HighQuality Assurance Manager 59,090 87,724Regulatory affairs Specialist 51,552 75,081Clinical Data Coordinator 43,470 62,959Clinical Data Analyst 48,401 73,192Clinical Data Manager 79,430 114,932SAS Developer 57,930 82,638Clinical Validation Specialist 52,122 82,088Clinical Business Analyst 46,759 65,991Project Manager I 45,549 85,811Project Manager II 63,109 107,301Project Manager III 77,791 122,997Business Development 90,239 110,897
Typical Salary RangeJob Title
Source: www.salary.com, www.payscale.com, www. hotjobs.yahoo.com/salary
Who Can Benefit?
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Eligibility Requirements
• Bachelor’s degree in one of life science, health science, medicine or alternative medicine, technology streams
• Doctors• MD• Nurses• Pharmacists • Laboratory assistants• Other health/medical related fields• IT and Engineering professionals
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About Us
Private training institute based in New Jersey• Provide advanced level training in clinical research and allied healthcare
fields• SEVP Approved School by United States Immigration & Customs
Enforcement to issue I20 for international students (www.ice.gov/doclib/sevis/pdf/approvedschools.pdf)
• Approved by New Jersey Department of Education and Department of Labor & Workforce Development
• Promote growth through academic & industry partnerships
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Our Recruitment Partners
• We have partnered with several leading hospitals, medical organizations, Contract Research Organizations etc. to provide internships to our students.
• The internships help students gain practical experience in the field to secure entry-level jobs.
• These internships provide rich experience of working on live clinical studies that is otherwise a very highly regulated environment.
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Our Programs
Adapting to the needs of the students:•Three-six month short term programs for graduates or professionals who wish to enter or transition into this field.•12 month long term programs for fresh graduates who want to gain an advanced and comprehensive training.•Online programs for working professionals.•Bridge programs to help secure full-time placements in clinical research.
Admissions Eligibility:•Minimum Bachelor’s degree in Life Sciences, Health Sciences, Pharmacy, Nursing, Alternative Medicine, Medicine or equivalent.•Proficiency in English
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Our Programs
We offer certificate, graduate and post-
graduate level training in:
•Clinical Research Associate
•Clinical Data Management & Oracle
Clinical
•Quality Assurance & Quality Control
•Regulatory Affairs
•Principal Investigator
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Program Features
• Live, classroom training as well as online sessions.
• Hands-on training with live projects for clinical research.
• Distinguished guest lectures.
• Internship programs to gain practical experience.
• Soft skills enhancement and career counseling services.
• Placement assistance.
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Contact Information
510 Thornall Street Suite 360 Edison NJ USA 08837
(732) 339-5410/ [email protected]
