FOR PART A

Learning Objectives For Intermediate Coordinator Seminar

Protocol Feasibility

• 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.

Budgets and Contracts

• 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.

Time Management

• Identify time wasters.
  
• Discuss ways to manage time effectively.
  
• Discuss how to apply organizational skills to a study coordinator role.

Brainstorming and Setting Personal and Professional Goals: Take Time to Re-Align

• 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”.

The Informed Consent Process in Special Populations

• Identify special populations that trigger unique regulations and procedures during the informed consent process.
  
• Describe regulations and best-practices regarding informed consent in populations such as pediatrics, prisoners, and the cognitively-impaired.
  
• List the difference between informed consent in the emergency-medicine setting versus emergency use of a test-article.
  
• Identify techniques to improve the design of the ICF Template.
  
• Define basic components of a standard operating procedure for informed consent that complies with FDA/ICH/GCP standards.

Clinical Research Personnel: What can you expect in Salaries, Workload and Benefit Packages

• 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.

Review and Summary:

• Demonstrate an understanding of intermediate knowledge related to the research process.

FOR PART B

Learning Objectives For Intermediate Coordinator Seminar

Be Your Own QA: Source Documents: The Jigsaw Puzzle of Clinical Trials

• Define necessary components of source documents that meet FDA/ICH requirements.
  
• Identify source document review techniques that nurse coordinators can use to enhance a site’s internal quality assurance program.
  
• Identify data inconsistencies that jeopardize protocol compliance.
  
• List the integral parts of an internal audit plan.

The Age of Technology: Internet Access, eCFRs, and Electronic Medical Records

• Identify current industry trends regarding the use of technology in clinical trials.
  
• Describe the impact of CFR Part II on the job of the nurse coordinator.
  
• Define basic technology requirements for a study site.

Maximizing Investigator Involvement: "Don't Practice Medicine Without a License".

• Identify the four topics of research that maximize investigator involvement.
  
• Describe methods the nurse coordinator can institute to maximize investigator involvement.

Enhancing Your Communcation Skills: Tips to Address Difficult Situations

• Identify four maxims of communication.
  
• Identify potential difficult communication situations in clinical trials.
  
• Describe conflict resolution steps.
  
• Define communication skills that reduce conflict in difficult situations.

Becoming a Mentor: Enhancing Your Training Skills

• Define the term mentor.
  
• Define the characteristics of a mentor.
  
• Describe how to develop a mentoring program.

FDA Inspections: What You Can Expect in an Audit

• 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.

Attracting New Trials: How to Grow Your Study Site

• 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.

Review and Summary:

• Demonstrate an understanding of intermediate knowledge related to the research process

The 2-day seminar is separated into two days to cover most all the topics available in our Level II “coordinator library”. Each topic is discussed relative to industry trends, audit outcomes, and insider observations. Each is reviewed utilizing real-world scenarios where class attendees participate in group discussions and learn industry best practices from other coordinators with industry-experience.

GOALS:
Each participant will gain additional insight into clinical research.
Each participant will be able to utilize this information in his or her practice as a study coordinator.

CONTACT HOURS:
Fear No Yellow Stickies-Intermediate Part A Coordinator Training: This provider-directed continuing nursing education activity is approved for 7.25 contact hours by LSNA. Louisiana State Nurses Association (LSNA) is accredited as an approver of continuing nursing education by the American Nurses Credentialing Center’s COA.

Fear No Yellow Stickies-Intermediate Part B Coordinator Training: This provider-directed continuing nursing education activity is approved for 7.25 contact hours by LSNA. Louisiana State Nurses Association (LSNA) is accredited as an approver of continuing nursing education by the American Nurses Credentialing Center’s COA.