About the Program
The clinical research field is a new, stimulating, and innovative career choice with many job opportunities. As the development of drug and medical devices increases, there is a need for scientifically trained professionals to coordinate research studies.
This program will give you an understanding of the landscape of clinical research including the duties of the following roles: clinical research associate (CRA), clinical research coordinator (CRC), data specialist, subject recruiter, research billing officer, compliance administrator, and other specialties.
This course is designed to provide a thorough overview of clinical research conduct, the drug development process, the roles of the Clinical Research Associate and Clinical Research Coordinator, and other key roles in the conduct of clinical research.
Session 1: Overview of the Clinical Research Process
Session 2: Clinical Research Personnel, Service Providers, and the Site Selection Process
Session 3: Human Subject Protections and Regulatory Oversight
Session 4: Clinical Trial Conduct, Monitoring and Record Keeping
Session 5: Components of Ethical Evaluation of Human Research and Privacy Considerations
Session 6: Recruitment and Retention, Drug Compliance and Accountability, and Study Close-Out Procedures
Session 7: Pharmacovigilance in Drug/Device Development
Session 8: Audits & Inspections: Ensuring Clinical Research Quality
Session 9: The Role of Data Management in Clinical Research
Session 10: Study Budgets and Contracts: Evaluation and Negotiation
Contact hours for this course: 30
|Course||Dates||Days & Times||Tuition & Fees|
|NS14101||September 17 to November 19, 2020||Thursdays 6:00 PM - 9:00 PM||$2058 + $75 book fee|
|NS14102||February 20 to March 20, 2021||Saturdays 9:00 AM - 3:30 PM||$2058 + $75 book fee|
|NS14103||May 11 to June 10, 2021||Tuesdays and Thursdays 6:00 PM - 9:00 PM||$2058 + $75 book fee|
It has become increasingly more important to use solid project management principles throughout the clinical research process. This course will benefit professionals interested in pursuing a clinical research career by providing a clear understanding of project management principles and processes.
Learn industry trends and best practices through real-world examples involving team projects and case studies presented by experts in the industry. Through discussion, presentation, and interaction, this course will broaden the participants' knowledge of the project management process in clinical research.
This course will provide an overview of the project management processes: initiation, planning, project life cycle, effective team building, execution, monitoring, tracking, risk management, change management, contingency planning, and close-out processes and procedures.
Contact hours for this course: 12
|Course||Dates||Days & Times||Tuition & Fees|
|NS14701||Sept. 28 – Oct. 26, 2020||Mondays 6:00 PM - 9:00 PM - ONLINE||$629 + $25 book fee|
|NS14702||Mar. 27, Apr. 10 & 17, 2021||Saturdays 9:00 AM - 1:00 PM - ONLINE||$629 + $25 book fee|
|NS14703||June 15, 17, 22 & 24, 2021||Tuesdays and Thursdays 6:00 PM - 9:00 PM - ONLINE||$629 + $25 book fee|
This course deals with the challenges related to managing change associated with career transition. Understand the clinical research field as well as your career strengths, career interests, and values. In addition, focus on your uniqueness and its value to yourself and the marketplace. Identify transferable skills and accomplishments that can be used in clinical research. Learn from clinical research experts how to market yourself and how to enter the clinical research arena.
This course is presented in two sessions that will prepare you to confidently embark on your job search.
Session 1: Computerized Systems in Clinical Research
Clinical Trial Management System Software
Session 2: Transitioning into and Growing a Career in Clinical Research
Résumé Basics, Job Search Strategies, and Internet Marketing
Panel Discussion: What Recruiters Focus on, Interview Strategies, and Negotiations - Industry Professionals
Pre/co-requisite: Project Management in Clinical Research and Clinical Research I and Clinical Research II.
Contact hours for this course: 6
|Course||Dates||Days & Times||Tuition & Fees|
|NS14901||Nov. 3 & 10, 2020||Tuesdays 6:00 PM - 9:00 PM - ONLINE||$299|
|NS14902||May 3 & 5, 2021||Monday & Wednesday 6:00 PM - 9:00 PM - ONLINE||$299|
|NS14903||June 29 & July 1, 2021||Tuesday & Thursday 6:00 PM - 9:00 PM - ONLINE||$299|
Please Note: All fall 2020 Clinical Research courses are being held online via Zoom.
Our Clinical Research Certificate Program includes a rigorous curriculum to prepare you for today's competitive marketplace.
All courses can be completed in less than three months or you can spread them out over two years. This is a Continuing Education program; it does not have an application process, and offers contact hours. We welcome you to register at any time.
You may register for all three required courses together for a $200 savings.
REGISTRATION AND PAYMENT POLICY
Registrations will be processed upon receipt of payment. Payment is due in full (tuition and fees) in order to be enrolled in any course.
Important: By registering for any of the course offerings, you assume responsibility for all related tuition, registration fees, lab fees, and book fees. You also agree to our refund and cancellation policy.
REFUND AND CANCELLATION POLICY
Requests for cancellations and refunds are accepted in only in writing (email: firstname.lastname@example.org) at least four weeks prior to the start of the course. A refund is provided (less a $75 administrative fee per course). No refunds will be made for cancellations requested within four weeks of the start date of the course or for no-shows.
Clinical research has developed into a complex set of activities, highly dependent on effective teamwork and integration of efforts by people with different backgrounds and disciplines. Because of the highly specialized nature of many aspects of the research process, there are many opportunities for individuals to specialize in areas such as data management, biostatistics, subject recruitment, and more. One important goal of this certificate program is to offer a clearer picture of these opportunities while at the same time providing a foundation in the basic principles of clinical research.
The past few decades have seen an explosion of our knowledge of basic biology, chemistry, and the pathophysiology of disease. This has inevitably led to the application and testing of these findings in the clinical setting, employing a variety of approaches including in vitro studies with human tissues, ex vivo studies, epidemiologic research, and clinical trials. Clinical research, which encompasses all these approaches, has evolved and gained in sophistication and complexity. It now represents an accepted discipline to be taught with a formal curriculum.
These multidisciplinary courses have been designed for professionals interested in moving into the field of pharmaceutical/clinical research. Hospitals and pharmaceutical companies seek out nurses or people with a science background for these roles because they have a scientific knowledge base, good interpersonal skills, and experience working with physicians and other nurses. Participants also use this certificate program as a refresher or as a review for certification examination.
This certificate program provides you with the tools you need to become successful in today's rigorous marketplace. All topics can be completed in less than two semesters. To earn a certificate, a student must:
Association of Clinical Research Professionals (ACRP) is forming a multi-stakeholder task force charged with defining the core competencies required of entry-level clinical research associates (CRAs).
This task force will identify the competencies required of entry-level CRAs/monitors, develop measures of competence, and advocate for standardization of identified CRA competencies across the clinical research enterprise.
This announcement follows publication of a position paper examining the current CRA workforce and calling for elimination of the commonly accepted and practiced two-year experience requirement for entry-level CRAs in favor of competence-based employment practices (see: A New Approach to Developing the CRA Workforce).
The arbitrary 2-years' experience requirement is contributing to a shortage of CRAs in the clinical research profession and is leading to inefficiencies at contract research organizations and clinical trial sponsors while doing nothing to ensure quality in clinical research.
There are at least 10,000 CRA open positions in the United States alone, and there is no evidence to suggest that number will decline anytime soon. A recent Brookings study, lamenting an overall employee shortage throughout the life sciences industry, singled out the CRA as one of the positions most in need of recruitment.
Massachusetts BioPharma Industry Employment has grown
9-10 times faster than the state and national
growth rates for all employment.*
There are more than 550 biotech and pharmaceutical companies located in Massachusetts; 314 of these companies are drug development companies. (BioSpace.com)
In a highly competitive job market like that seen during the economic downturn, education becomes an increasingly important factor in candidate selection, especially early in the hiring process when employers are likely to use degree held as a way to narrow the applicant field. (BioSpace.com)
U.S. Bureau of Labor Statistics, Quarterly Census of Employment and Wages (QCEW); MassBio
The field of Clinical Research is rapidly expanding and there are many career opportunities. This program will give you an understanding of the "landscape" of clinical research, including the duties of the following roles: Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), data specialist, subject recruiter, research billing officer, compliance administrator, and other specialties.