This
course provides the background needed to become an integral part of the
clinical research team (for drugs and devices) and explores the need to understand
the rationale behind quality performance and team-playing. The roles and
responsibilities of Clinical Administrative Support will be discussed in terms
of obligations to the study team and the importance of compliance with Standard
Operating Procedures and Standard Office Practices. Although the course is
designed for administrative staff with less than one year experience, those
with some experience may also find this course helpful in providing the
rationale for doing tasks in a specific manner, refining their skills, and
sharing their experiences and helpful techniques with their colleagues.
- Recognize the importance of a knowledgeable
clinical support staff
- Define the common terms used in the
field of drug and device research
- Describe the basics of the
drug/device development process
- Describe the basic principles of
Good Clinical Practice and the regulations that govern clinical research
- Discuss the basics of clinical trial
design and use of a study protocol
- List essential Standard Operating
Procedures needed
- Describe the responsibilities of
various members of the clinical team
- List the essential documents needed
for clinical trials and become familiar with the proper preparation of the
documents needed to support the trial process
- Discuss the importance of training
and maintenance of current training records
- Describe the rationale behind
building quality into the filing system
- Discuss the “dos and don’ts” in the
event of a regulatory agency audit
- Clinical Research Administrative Support Staff
Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.
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biographies
$835
Includes up to 20
participants at one site. All participants (up to 20) are eligible for
“Certificates of Attendance,” and accreditation, provided that accreditation
requirements are met. For groups larger than 20 or for additional sites, please
call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.
Barnett International is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. Participants will
receive 2.5 hours (0.25 CEUs) of continuing education credit for full
participation, including the completion of a pre-test, post-test, and program
evaluation. Barnett International will
issue a receipt of completion for earned CEUs within three weeks of program
completion. ACPE#: 0778-0000-19-005-L01-P.
Released: 2/19.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.