Throughout the history of clinical trials, research professionals have been a critical part of medical breakthroughs that have improved the lives of millions.

But there are still great strides to be made toward safer and more reliable treatments for breast cancer, diabetes, and heart disease. Now you can make a difference in this relevant, life-changing field by earning a Graduate Certificate in Clinical Research Administration from Walden University. Broaden your understanding of the process that produces high-impact medical innovations. Explore the legal, regulatory, and ethical concerns that govern the field.

The Graduate Certificate in Clinical Research Administration is designed for:

  • Medical doctors, scientists, attorneys, nurses, or public health professionals who are ready to take their career in a new direction.
  • Students interested in courses that feature great credentialed faculty, including medical doctors, lawyers, and heads of major companies.
  • Professionals who are qualified to complete assignments based on clinical research content, including epidemiologists, biostatisticians, and researchers.
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  • Tuition and Fees

  • Program Data

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Completion Requirements

  • 12 total semester credits

You can complete the Graduate Certificate in Clinical Research Administration in as little as 8 months. Time to completion may vary by student, depending on individual progress and credits transferred, if applicable. For a personalized estimate of your time to completion, call an enrollment adviser at 1-866-492-5336.

You can also save time and money when continuing on to earn your master’s degree. Credits earned from this certificate program may be applied toward Walden’s Master of Science in Clinical Research Administration.

Courses

  • Introduction to Clinical Research

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    Students in this course are provided with an overview of the clinical research enterprise from a historical and evolutionary perspective, including examples of landmark studies and controversies. Students consider the context in which researchers design and implement human clinical studies and explore a variety of topics, including the components, general principles, and issues in clinical research; types and classification of research studies; formulation of research objectives and outcomes; definition and phases of clinical trial protocols; and the roles and responsibilities of the clinical research team and study sponsors. Students become familiar with key medical terminology, including basic concepts of health, wellness, and disease. They work toward developing critical-thinking, written, verbal, and interpersonal communication skills as well as competencies needed for student success in an online environment. Students also begin work on their portfolio through assigned learning activities, including a journal of interactions and interviews with professionals in the field, an assessment of an organization’s culture, and the identification of management challenges in clinical research.

  • Ethical, Legal, and Regulatory Considerations in Clinical Investigations

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    The nature of human clinical research and clinical investigation facilitates a host of ethical, legal, and regulatory issues related to the treatment of subjects, personal privacy, and institutional compliance, among others. Students in this course examine ethical codes of conduct, regulatory requirements, and existing laws that govern clinical research in the context of historical events that contributed to their development. They also explore recruitment and protection of human subjects; diversity and vulnerable populations in research; informed consent; privacy and confidentiality; the role of independent review committees; and the importance of reporting serious adverse events (SAEs). Students also discuss social and ethical implications of genetic technologies and research. Applying course concepts, students complete an FDA form for a clinical trial in their region, deepening their understanding of legal protocol.

  • Design and Conduct of the Clinical Protocol

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    An introduction to the basic elements of research design for clinical inquiry is provided in this course. Students explore the methods and goals of clinical research; formulation of the research objective and hypothesis; identification of outcome measures; issues of reliability and validity; randomization procedures; documentation requirements; and data collection, analysis, and interpretation. Sharpening critical-thinking skills, students consider the potential risks and benefits of a clinical trial case study, which they use to justify continuation or termination of the drug development process. They also examine practical aspects of clinical trial management, including the design of the case report form (CRF), clinical laboratory and multicenter trial administration, and outsourcing. Through a review of scholarly literature, students explore and describe the ethical and regulatory requirements for which professionals must account in the design of a clinical research study. Additionally, students explore health disparities and cultural diversity as factors that affect participation of subjects in clinical trials.

  • Good Clinical Practice (GCP) in Managing and Monitoring Clinical Trials

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    Through this course, students learn the process and procedures of managing and monitoring a clinical trial from study initiation to closeout. Students examine the basic tenets of good clinical practice (GCP), including historical considerations, compliance, and recruitment of study participants, focusing on quality assurance and data safety monitoring boards (DSMBs). Through discussions and application-based assignments, students investigate and describe the relationship between regulations and GCP; how GCP affects the practical elements of conducting clinical studies; the challenges of multi-center or large-scale trials, such as risk assessment and management; protocol management and amendments; and audits and various considerations for reporting requirements. Students in this course are provided with official guidance on GCP from the International Conference on Harmonization (ICH) as well as operational imperatives of GCP.

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2013-2014

 Curriculum Component  Requirements  Cost
 Courses  12 total semester credit hours  $760 per semester credit hour
 Technology Fee  per semester  $150

Tuition and fees are subject to change.

Call 1-866-492-5336 for information about a full range of options for:

Walden is committed to providing the information you need to make an informed decision about where you pursue your education. Please find below detailed information for the Graduate Certificate in Clinical Research Administration relating to the types of occupations this certificate program may lead to, completion rate, program costs, and median loan debt of students who have graduated from this program.

Occupations
Program Completion Rate
Program Costs
Median Loan Debt

Occupations—This program generally prepares students to enter the types of occupations listed below. For more information on these specific occupations, visit www.onetonline.org.

In addition to this list, there are other career options that graduates of this program may choose to pursue. To enter certain professions, students may need to satisfy specific additional requirements established by state and/or professional organizations in addition to completing their program.

View examples of our student and alumni accomplishments in their chosen fields.

Occupation Name* Occupation Code*
Medical and Health Services Managers 11-9111

*The “occupation name” is a general job title. “Occupation code” refers to the U.S. Bureau of Labor Statistics’ Standard Occupation Classification.

Program Completion—This program had fewer than 10 graduates during July 1, 2011 to June 30, 2012. As a result, Walden does not disclose this information in order to protect students’ privacy per U.S. Department of Education guidelines.

Program Costs—The total program costs are the estimated average costs over the duration of the program, excluding any scholarship or tuition reductions, for students completing the program on time. These costs can vary based on the number of credits. Typically, tuition and fees are subject to change annually.

Expense  Cost
Tuition and Fees $9,467
Books and Supplies $742
Room and Board Not applicable

View cost per credit in the Tuition and Fees section.

Median Loan Debt—This program had fewer than 10 graduates during July 1, 2011 to June 30, 2012. As a result, Walden does not disclose this information in order to protect students’ privacy per U.S. Department of Education guidelines.

For assistance in deciding which online certificate program fits your goals, request information or speak with an enrollment advisor by calling 1-866-492-5336. A list of international toll-free phone numbers is available for students outside the United States.