About the Program
Behind every great doctor, scientist, or researcher making breakthroughs is a group of administrators making sure that research is performed efficiently, ethically, safely, legally, and with financial sustainability. All these people have what we call ‘hidden careers’ because they do not have dedicated schools or degree programs that prepare candidates for their first job in these fields.
Research administrators come from a variety of backgrounds and have a wide variety of degrees and transferrable skills in areas such as business, finance, administration, law, education, health care and sciences, communications/writing/English, and social sciences. They also work in a variety of settings including healthcare organizations, universities, government, research institutes, pharmaceutical and biotech companies, and research service companies.
Research administrators come from a variety of backgrounds and have a wide variety of degrees and transferrable skills in areas such as business, finance, administration, law, education, health care and sciences, communications/writing/English, and social sciences. They also work in a variety of settings including healthcare organizations, universities, government, research institutes, pharmaceutical and biotech companies, and research service companies.
Program Overview
Didactic training (online)
Supports all learning objectives of internship. Can be started before your internship begins and must be completed by the completion of the internship.Regulatory Oversight rotation
- List and explain the purpose of the regulations that govern human, animal and biosafety research
- Understand the roles and responsibilities of the regulatory committees who are responsible for research review and oversight
- Describe the day-to-day regulatory and administrative support responsibilities of a regulatory analyst
Integrity and Compliance rotation
- Describe how a researcher must behave as a responsible member of society, a steward of high-quality data, and maintains the highest ethical standards in the conduct of research
- Describe the job functions of an Analyst and how they ensure research integrity and compliance
- Give examples of the types of noncompliance or research misconduct and how they are prevented, addressed, and mitigated.
- Demonstrate proficiency in use of online systems used to check for signs of research noncompliance or misconduct prior to submitting a grant funding proposal or scholarly manuscript.
Regulatory Affairs rotation
- List and describe the purpose of the regulatory requirements for FDA approval of an investigational new drug or device (IND or IDE)
- List and define the steps of the regulatory pathway for investigational drugs, devices and biologics
- Describe the process for submission to these regulatory pathways
Clinical Research Finance rotation
- Understand the importance of Medicare Coverage Analysis & it uses
- List and define the steps of conceptualizing, starting, running, and finishing and clinical research study budget
- Understand clinical research study budget development & negotiations
- Understand the organization’s revenue cycle and the impact of clinical research
- Identify and explain the purpose of the regulations governing overall financial and billing compliance
Education News
Education in Methodology
Education in Methodology