Course Certificate In. Pharmaceuticals and Medical Research: Clinical Research Monitoring & Coordination

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1 Course Certificate In Pharmaceuticals and Medical Research: Clinical Research Monitoring & Coordination Welcome to the latest in distance learning courses designed to prepare you, on your own schedule, to join in new opportunities in pharmaceuticals and biotechnology. Pharmaceutical and Biotechnology companies, hospitals and even your local general practitioner and specialist are collectively seeking thousands of specially trained staff for new opportunities in clinical research drug trials. Intense need for trained trial managers: There are over 42,000 clinical research trials taking place in the US alone. An estimated 100,000 clinical trials worldwide are seeking to employ more than 1,000,000 persons in helping to prove the safety and efficacy of new drugs. Practical Preparation to enter the biotechnology field: This course is designed to meet your needs in training and preparing for clinical trial management positions. Students will enhance their knowledge of the roles and responsibilities related to clinical trials. The course prepares you to join research teams striving to develop cures and treatments for myriad life threatening diseases that face humankind today. Gain new careers skills and access: With the knowledge and job skills gained, you can help to meet the ever growing demand for trained professionals to develop exciting new therapeutics for the 21st century in the biotechnology, pharmaceutical and medical device industries. It also serves others with valuable training to access new opportunities in this field. Course Certification: This ANCC approved certificate course details the essentials of clinical research and trial management for professionals seeking qualifications to work in clinical research at pharmaceutical companies, hospitals, clinics or universities. The American Nurses' Credentialing Center Commission has accredited this course for 33 contact hours for Nursing Continuing Education Units (CEUs). Innovative video distance learning employs a unique multimedia video lecture and slide combination that bring the course to your very own PC anywhere, anytime. You will learn the regulatory and scientific standards of research through these coordinated lectures, readings and exercises, not just to provide theory, but to provide actual real world job insight. Course experience is designed to prepare for new and exciting careers that allow you to choose to work and travel worldwide or locally with the thought leaders of academic and industrial research. All with the goal of delivering to patients the latest and most innovative medical products. So whether you are preparing for a new position in pharmaceuticals or just want to gain insight to the clinical research

2 process and improve your resume. Job seekers: Job search assistance is available upon course completion through our course partner, Applied Quality Solutions. Take this course, at your own pace, and gain a deeper understanding for new medical treatments and the wide variety of positions available to you through this plug and play CD with a seasoned executive in the field of pharmaceuticals. We hope you enjoy this important new career enhancing course.

3 Overview: Clinical Research Monitoring and Coordination Course Certificate Course Description: Clinical Research Monitoring and Coordination For those seeking qualifications to manage and conduct clinical trials, the course emphasizes practical and regulatory requirements essential to successful trial management. Included are key tips from industry experts to enhance your trial management abilities. This course is essential to obtaining and advancing your career. As well, you will learn many real world and practical points in successful trials. Topics: Describe key steps in the Drug Development process. Gain insight to managing roles/opportunities in Clinical Research. Identify ethical issues in clinical research. Evaluate the development of new products. Institute and obtain proper Informed Consent for all types of study subjects. Understand the latest Good Clinical Practices as applied to medical research. Learn to employ efficient and appropriate study subject recruitment methods. Develop a suitable clinical trial protocol and study budget. Identify product adverse effects and proper reporting requirements. Develop qualifications sought by the Pharmaceutical, Biotech & Medical Device industries Much more You will be allocated up to 3 months to complete the 10 chapters and 2 open book exams based on CD lecture series and coordinated slide presentation.

4 Frequently Asked Questions Can I take this course and qualify to get a job in clinical trial management? Yes. This course supplies the essential knowledge to work in many different roles in clinical research. Your professional experience, education and background enhance the prospects. This course is designed to relate industry standard for trial management to a broad array of professionals and give you practical training. What opportunities are open to me once I enter the Pharmaceutical field? This course will examine a variety of roles in Clinical Research such as: Clinical Research Coordinator, Clinical Research Associate, Clinical Scientist, Medical Research Associate, Medical Monitor, Medical Writer, Data Manager, Trial technician, HR research staff recruiter, Regulatory Affairs, Quality Assurance, to name a few. Your personal interests can help you decide where to specialize. Other Pharmaceutical personnel who benefit from this course: Sales/Marketing reps, Manufacture (GMP) managers and technicians, Non clinical (GLP) experts and technicians. Are there also opportunities for Healthcare professionals? Absolutely! Healthcare professionals play an important role in clinical research and will gain from this course. Nurse, Nurse practitioners, Physicians, Physicians Assistants, Pharmacists, Pharmacologists, Medical Technologists, Laboratory Technicians, Physical Therapists, Respiratory Therapists are sought for pharmaceutical trial management. Are there any prerequisites for this course? There are no separate course requirements. Will this certificate help me since I currently work in the pharmaceutical field? This course is also designed to enhance your value to work in clinical trials or transition to a new role in pharmaceuticals. The FDA recognizes this continuing education as essential to enhance the caliber of trial management staff. Do I need a specific medical background? A life science background is not a prerequisite since many opportunities exist for individuals with varied academic and professional backgrounds in the area of clinical trial management.

5 Will it help me to take this course without having a full degree in nursing or strong science background? Yes. There are many career options in clinical research that do not require a specialized scientific education. You may be interested in medical writing, regulatory affairs, data management, patient recruiting or perhaps, training and development. These positions as well as others are explored in the course with a focus on trial management. Can you help me get a new job? Immaculata University and Applied Quality Solutions supply this continuing education course to qualify and better prepare you for positions in the clinical research field. AQS can put you in touch with agencies specializing in pharmaceutical placement and provide on line job listings focused on your needs. What if I have a content or technical question about the course? You can send an to appliedqualitysolutions@yahoo.com for prompt response by our instructor/consultant. AQS monitors for your inquiries and questions 24h/7days a week and guarantees a prompt response to keep the course moving and exciting for you. When necessary, teleconferences with the instructor can be arranged. How long to I have to complete the course? You have up to 3 months (12 weeks) to complete the course. We suggest that you try to complete one chapter per week. Of course, you may move at your own pace and complete much sooner. How do I get my certificate? Return of completed midterm and final exams is all that is required. When tests are received and scored, Immaculata University will issue a certificate of completion that will be a permanent record to attest to your contact hours earned and expert training received. To register contact Immaculata University at (610) , extension 3212 or sneiner@immaculata.edu Cost: $1875 Credit cards are accepted. Cancellations prior to the shipment of materials will receive a full refund.

6 Upon completed registration, you will receive, by courier, a packet of course materials, including your text manual, regulation handbook, and lecture CD. Begin your readings and launch the CD in any personal computer or laptop and you are on your way! Any course content and/or technical questions, please appliedqualitysolutions@yahoo.com Support is always available 24/7!