Coordinator Entry Level
Key Objectives
- Describe what research is and why it is done
- Describe the background/history of the research process
- Discuss terminology related to the research process
- Review the IRB process and it’s impact on research
- Explore the role of the nurse in the overall clinical
research process
- Summarize the four different Phases of research studies
- Identify the elements of a drug-related study protocol
and the value of following the appropriate protocol
- Describe the importance of maintaining the regulatory
binder during the research process
- Identify the required and additional elements of the informed
consent as it relates to the research process
- Examine the criteria necessary to provide subject care
while a subject is enrolled in a study to assure following
the appropriate research protocol
- Discuss the drawing of labs and the type of tubes used
to collect specimens
- Describe the process of Adverse Event (AE) reporting
- Examine the process related to the nurse or pharmacist
drug accountability during a research study
- Describe the different types of source documents
- Summarize the process for preparing for Clinical Research
Associates (CRA) visits
- Identify the research organizations, readings and websites
- Critique a sample completed source document for errors
and/or for missing documentation
- Transcribe data from a sample source document onto a Case
Report Form (CRF)
- Demonstrate an understanding of basic knowledge related
to the research process
Why Take This Course
The class is designed for those with zero to two years of
research experience who are functioning as a study coordinator.
It is also beneficial for those considering entry into this
field or those who are relatively new to the conduct of clinical
trials.
Course Content and CEU Information
This two-day course provides those with or without medical
training immediate assistance in the role of a study coordinator.
A comprehensive review of the drug development process, FDA/ICH
requirements and basic terminology is matched with hands-on
activities in protocol review, the informed consent process,
and proper source document/CRF completion. The course involves
group discussions and detailed exercises of materials presented.
Key Topics:
- Basic Terminology and the Clinical Research Process
- FDA/ICH Definitions, History and Requirements
- Maintaining the Regulatory Binder
- The Informed Consent Process
- Generating Great Source Documents
- Research Patient Care: Recruitment Through Study Determination
- AE and SAE Reporting
- Tips on Drug Accountability
- Preparing for the Monitoring Visit
- Critique of Mock Protocols and Informed Consents
- Completion and Critique of Mock Source Documents and
CRFs
CEUs Earned
- 13.7 contact hours of nursing continuing education by
the Louisiana State Nurses Association
Coordinator
Intermediate Level
Key Objectives (Part One)
- List the critical categories of research that can affect
protocol feasibility at a study site.
- Define the protocol characteristics that affect the success
of study operations at a clinical site.
- Identify the extraneous protocol factors that affect
study nurse/coordinator workloads and general study conduct.
- Identify Facility Logistics as it applies to protocol
feasibility.
- Demonstrate how to complete a protocol feasibility form.
- Identify primary challenges with the research budget
process.
- Define internal and external cost factors within a protocol
in order to enhance budget design.
- Prepare a sample budget based on protocol cost factors.
- Summarize study contract issues, which increase legal
risks to study sites.
- Define negotiating tips a nurse coordinator can use to
maximize study budgets and contracts.
- Identify time wasters.
- Discuss ways to manage time effectively.
- Discuss how to apply organizational skills to a study
coordinator role.
- Clearly set personal and professional life goals and
be able to write the goals using affirmative language.
- Clearly visualize their goals.
- Create the “Relaxation Experience”
- Describe the special informed consent scenarios that
nurse coordinators face in clinical trials.
- Identify the components of an informed consent standard
operating procedure (SOP) that complies with FDA/ICH/GCP
Standards and insures compliance.
- Identify what can wrong with the consenting process.
- Define the industry-reported salary ranges of study coordinators
relative to training, experience, and geographic location.
- Identify atypical benefits available to a nurse study
coordinator.
- Define the standard workload of a nurse study coordinator.
- Demonstrate an understanding of intermediate knowledge
related to the research process
Key Objectives (Part Two)
- Describe “Good” traits of source documents.
- Identify source document techniques that nurse coordinators
can use to enhance a site’s internal quality assurance
program.
- Identify data inconsistencies.
- List the integral parts of an internal audit plan.
- Identify current industry trends regarding the use of
technology in clinical trials.
- Describe the impact of CRF Part II on the job of the
nurse coordinator.
- Define basic technology requirements for a study site.
- Identify the four topic of research that maximizes investigator
involvement.
- Describe methods the nurse coordinator can institute
to maximize investigator involvement.
- Identify 4 maxims of communication.
- Identify potential difficult communication situations
in clinical trials.
- Describe conflict resolution steps.
- Define communication skills that reduce conflict in difficult
situations.
- Define the term mentor.
- Define the characteristics of a mentor.
- Describe how to develop a mentoring program.
- Define the phrase “FDA Audit”, other audit
terminology and expectations from a FDA Audit.
- Discuss differences between and audit and a routine monitoring
visit.
- Identify types of FDA audits and how to participate in
a FDA Audit.
- Identify factors that affect trial placement by a study
sponsor.
- Define the methods nurse study coordinators may utilize
to attract new trials.
- List the therapeutic areas with the fastest growth opportunities
in clinical trials.
- Demonstrate an understanding of intermediate knowledge
related to the research process.
Why Take This Course
This course is directed to those with greater than two years
of coordinating experience or those who have completed the
entry level training program. It is also beneficial to those
interested in expanding their research knowledge in areas
outside routing training.
Course Information
Our intermediate training program focuses on the more advance
topics faced by study coordinators. The course is separated
into two classes (parts) that may be taken independently
of one another. Topics are reviewed utilizing real-world
scenarios where class attendees participate in group discussions
and learn industry best practices.
Part I Topics
- Protocol Feasibility
- Special Populations and the Informed Consent Process
- Budgets and Contracts
- Time Management
- Brainstorming and Goal Setting
- Clinical Research Salaries
Part II Topics
- Improving Data Quality to Avoid Data Queries
- Maximizing Investigator Involvement
- Enhancing Communication Skills
- Electronic Source Documents and eCRFs
- Mentoring
- FDA Inspections
- Attracting New Trials: How to Grow Your Site
CEUs Earned
FDA Inspections: What You Can Expect in an Audit
Goals
- Each participant will gin additional insight into more advanced topics of clinical research.
- Each participant will be able to utilize this information in his or her practice as a study coordinator.
Objectives of the program:
Participants will:
- Define the phrase "FDA Audit", other audit terminology and expectations from a FDA Audit.
- Discuss differences between an Audit and a routine monitoring visit.
- Identify types of FDA audits and how to participate in a FDA Audit.
CEUs Earned
This Presenter-Directed Activity for 1.7 contact hours of nursing continuing education is approved by the Louisiana State Nurses Association (LSNA), an accredited approver by the American Nurses Credentialing Center's Commission on Accreditation.
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