Lead the Science and Business of Developing New Therapeutics
The George Washington University’s (GW) online Graduate Certificate in Clinical Research Administration will prepare students to be strategic leaders who drive success for their health care and research organizations. The 18-credit hour graduate certificate will strengthen students’ career prospects while developing management skills for clinical research administration. All courses in the clinical research certificate program are transferable to the MSHS, so students can seamlessly matriculate into the Master’s in Clinical Research.
GW's high-quality and innovative curriculum is aligned with the eight published Competency Domains for the Clinical Research Professional as identified by the Joint Task Force for Clinical Trial Competency.1
Eight competency domains:
1. Scientific Concepts and Research Design
2. Ethical and Participant Safety Considerations
3. Medicines Development and Regulation
4. Clinical Trials Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork
Upon completion of the Graduate Certificate in Clinical Research Administration program, students will:
- Demonstrate a solid grasp of the clinical, regulatory and business requirements in the planning and conduct of a clinical trial.
- Integrate research design principles with scientific, medical, regulatory and commercial requirements by creating clinical development plan sections to provide adequate benefit to risk assessments in the development of a new investigational product.
- Evaluate the importance of assuring data integrity in a clinical trial and in the preparation of various clinical/regulatory documents through professional assignments such as quality checking a clinical study report.
- Formulate strategies to address ethical and cultural considerations for effective and compliant domestic or international clinical trial conduct, in relation to key areas such as human subjects’ protection, subject recruitment/retention, data integrity and risk assessment.
CORE COURSES (15 credit hours)
CRA 6201: Critical Analysis in Clinical Research (3 credit hours)
Students develop the academic skill sets necessary to succeed in this program in the context of exploring scientific, clinical and regulatory concepts required in medicines development. Students demonstrate their critical analysis skills through literature research, analysis of information from various perspectives, and formulating their own opinions in choosing their ‘defendable positions’, rather than stating the “correct answers”.
- Synthesize various perspectives from professional, scholarly clinical research and regulatory literature.
- Analyze the role of critical analysis/evidence-based decision making throughout the process of pharmaceutical new product development.
- Develop an evidence-based argument in support of a strategy addressing a clinical research challenge.
- Examine the components of therapeutic product development from discovery through late stage development.
CRA 6202: Medicines Development (3 credit hours)
This course examines the nonclinical, clinical, commercial, regulatory and risk assessment strategies required to develop a clinical development plan for an approvable, marketable new therapeutic and propose life cycle management strategies.
- Analyze the critical role that nonclinical testing plays in assessing initial safety prior to clinical trials and the types of studies conducted during development to demonstrate long term safety.
- Evaluate and utilize the strategies attributed to different clinical phases in the clinical development process.
- Apply appropriate regulatory requirements required to create a regulatory strategy for a particular therapeutic category.
- Examine the commercial attributes in addition to the clinical characteristics needed to develop an approvable, marketable new investigational therapeutic that demonstrates an adequate benefit/risk profile and commercial viability.
CRA 6203: Partnerships with Human Subjects (3 credit hours)
This course explores regulatory, policy, ethical and practical considerations associated with the engagement, recruitment, retention and interaction with human research subjects.
- Apply regulatory and ethical considerations to decision-making activities involving recruitment and retention of human subjects in clinical trials as well as the dissemination of clinical trial results to patients by evaluating past and current practices with human subject participants.
- Evaluate the definition and meaning of partnership, relationship and engagement with patients in the context of clinical research and how these influence societal perceptions of clinical research at large and individual decisions to participate in clinical research activity.
- Analyze various methods and their effectiveness for enhancing clinical trial participation and engagement of patient populations within the subject recruitment and retention planning process.
CRA 6204: The Clinical Research Industry (3 credit hours)
The Clinical Research Industry integrates project management principles, decision-making models, cross cultural competency, and interdisciplinary team dynamics to facilitate effective and efficient conduct of clinical trials.
- Integrate core project management principles and processes for effective clinical trial management.
- Evaluate how elements of cultural competency, project management and meeting management improve the performance of a culturally diverse, multi-disciplinary team.
- Assess organizational, cultural and personnel factors that influence successful clinical trial performance.
CRA 6209: Monitoring Clinical Research (3 credit hours)
This course explores how to manage risk and safety assessments to ensure quality in clinical research.
- Examine how to manage risk and ensure quality in clinical trial conduct by applying management concepts and training methods.
- Explore safety risk assessment during clinical development and post marketing for new products.
- Appraise data quality assurance methods including SOPs to ensure data quality.
ELECTIVE COURSES (3 credit hours)
Discover Excellence in Clinical Research Leadership
To learn more about the Clinical Research Certificate online, contact an Admissions Advisor today at (844) 386-7323 or request more information.
1Sonstein, S. A., Seltzer, J., Li, R., Silva, H., Thomas Jones, C., & Daemen, E. (June 2014). Moving from Compliance to Competency: A Harmonized Core Competency Framework for the Clinical Research Professional. Clinical Researcher, 17-23. doi: 10.14524/CR-14-00002R1.1