Education

Contracts and Clinical Trials Office

COORDINATOR COMPETENCIES

	OBJECTIVES
Clinical Research Coordinator (CRC)	Describe the roles and responsibilities of a Clinical Research Coordinator (CRC) Identify the clinical research offices and resources within LSU Health New Orleans Identify the clinical research systems used at LSU Health New Orleans and understand how they interact with one another Discuss the studies that make up your research portfolio Describe the career progression within clinical research professionals
Clinical Research Coordinator (CRC) Foundations	Offered by CITI The CRC Foundations course provides clinical research professionals with basic training tailored to the CRC’s fundamental role in the conduct of clinical trials. It is designed for new CRCs and can be used by organizations as onboarding training. It may also be useful to those pursuing a career in clinical research.
Clinical Research Coordinator (CRC) Advanced	Offered by CITI The CRC Advanced course provides clinical research professionals with advanced training tailored to the CRC’s critical role in the conduct of clinical trials. It is designed for CRCs who have taken CRC Foundations, or those with two or more years of experience as a CRC. It complements the foundational course, and may be used for professional development and/or as a refresher course.
Clinical Research Nurse Coordinator (CRNC)	Describe the roles and responsibilities of a Clinical Research Nurse Coordinator (CRNC) Identify the clinical research offices and resources within LSU Health New Orleans Identify the clinical research systems used at LSU Health New Orleans and understand how they interact with one another Discuss the studies that make up your research portfolio Describe the career progression within clinical research professionals Define nursing responsibilities, competencies, and credentialing for the CRNC role
Regulatory Coordinator (RC)	Describe the roles and responsibilities of a Clinical Research Coordinator (CRC) Identify the clinical research offices and resources within LSU Health New Orleans Identify the clinical research systems used at LSU Health New Orleans and understand how they interact with one another Discuss how to find and follow applicable standards, guidelines, regulations, policies, and procedures for performing clinical research at LSU Health New Orleans Describe the career progression within clinical research professionals

	OBJECTIVES
Research Ethics in the Context of Clinical Research	Describe historical unethical research studies that led to the establishment of ethical guidelines and regulations governing clinical research Describe the main ethics principles in the context of human subject research Describe the differences between FDA vs. HHS vs. ICH Guidelines, and when each guideline is applicable
Institutional Review Board (IRB) Overview	Describe the IRB’s scope of oversight – what does and what does not require review by the IRB Describe the IRB review process Outline a basic overview of the system, including how to gain access to the system, how to use and navigate within the system, how to find out study status, and how to get help with the system Describe how to communicate with the IRB and make use of the many tools available on the IRB website
Submitting an IRB Application (Live Walk-Through)	The live demonstration will describe the workflow among the main research workflow system and will introduce users to the system, basic navigation and initial protocol submission
HIPAA	Define HIPAA, protected health information, and covered entity Discuss HIPAA Authorizations and how they related to research Discuss Waivers to the HIPAA Authorization Provide tips for collecting HIPAA Authorization Identify how and when to report Privacy Violations

	OBJECTIVES
Investigational New Drug (IND) Sponsor and Investigator Responsibilities	Define Investigational New Drug (IND), Sponsor, and Investigator Discuss the responsibilities of a Sponsor with an IND Discuss the responsibilities of an Investigator using an IND
Investigational Device Exemption (IDE) Sponsor and Investigator Responsibilities	Define Investigational Device Exemption (IDE), Sponsor, and Investigator Discuss the responsibilities of a Sponsor with an IDE Discuss the responsibilities of an Investigator using an Investigational Device with an IDE
GCP - Drug Development	Offered by CITI The GCP - Drug Development course covers Good Clinical Practice (GCP) and U.S. Food and Drug Administration (FDA) essential topics for clinical trials with investigational drugs and/or biologics. It is intended for research personnel involved in drug and/or biologic studies.
GCP - Device Development	Offered by CITI The GCP - Drug Development course covers Good Clinical Practice (GCP) and U.S. Food and Drug Administration (FDA) essential topics for clinical trials with investigational devices. It is intended for research personnel involved in device studies..
GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)	Offered by CITI The GCP U.S. FDA Basic course covers Good Clinical Practice (GCP) and U.S. Food and Drug Administration (FDA) essential topics for clinical trials with investigational drugs, biologics, and/or medical devices. It is intended for research personnel involved in drug, biologic, or device studies and who would benefit from FDA-focused training. It covers key topics in clinical research including: Reviewing FDA regulations Identifying investigator and sponsor obligations Discussing new drug development Comparing International Council for Harmonisation (ICH) GCP E6 and FDA regulations Describing how to detect and report adverse events Auditing and monitoring expectations
Sponsor Monitoring	Discuss what is the purpose of Sponsor Monitoring Outline steps for scheduling and preparing for a Monitoring visit Discuss what happens during a Monitoring visit Discuss what happens after a Monitoring visit
FDA Inspections	Discuss the purpose of an FDA Inspection Identify the types of inspections the FDA conducts Walk through the Inspection process from initial notification to responding to deficiencies.
Reportable New Information	Define Reportable New Information (RNI) Define the different categories of RNI Discuss the reporting requirements for RNI Discuss the process for amending the study as a result of an RNI
ClinicalTrials.gov Registration and Results Submission Overview	Describe what ClinicalTrials.gov is Discuss how you should register your study (FDA, NIH & ICMJE) Identify FDA required informed consent language Identify who is responsible for registration (Responsible Party) Discuss results reporting requirements Describe how registration works at LSU Health New Orleans Identify Helpful Resources
Feasibility	Outline questions to consider when assessing Feasibility
Study Closeout	Prepare studies for regulatory closeout as dictated by institutional guidelines Recall the basics of document storage, including document retention

	OBJECTIVES
Developing the Informed Consent Form	Discuss the purpose of informed consent and of documentation Identify and define the elements of the informed consent form Identify and interpret policies and regulations related to the informed consent process and Health Insurance Portability and Accountability Act (HIPAA) Describe requirements related to ensuring participant comprehension of informed consent and ICFs (e.g., reading level and translation requirements)
Informed Consent Process and Procedures for Clinical Research	List and describe supporting documentation of the informed consent process (e.g. consent forms, consent notes, waivers). Identify and interpret policies and regulations related to the informed consent process and HIPAA Describe requirements related to ensuring participant comprehension of informed consent and ICFs (e.g. translation requirements) Describe how the consent process is planned and diagnose errors in consent planning Describe the procedure for conducting and documenting consent for participants

	OBJECTIVES
Recruitment Methods and Regulations	Discuss LSU Health New Orleans approved methods for recruitment. Recognize the process for obtaining IRB approval for recruitment plans and materials
Screening	Define the difference between pre-screening and screening Describe the ways pre-screening can be conducted Describe the ways screening can be conducted

	OBJECTIVES
Specimen Management - Bloodborne Pathogens	Offered by CATS
Specimen Management - Shipping Biological Materials	Offered by CATS

	OBJECTIVES
Research-Related Agreements	Identify typical contracts and agreements used in research Describe processes for putting agreements in place Identify notable clauses and language that are specific to LSUHSC contracts and agreements
Clinical Trial Agreements - Basics	Offered by CITI CTAs are one of several key documents that govern the conduct of clinical trials. A CTA serves as a legally binding contract between a sponsor, site, and researcher, and outlines each party’s responsibilities and obligations for the clinical trial. It is imperative that researchers and sites understand the importance of CTA development, negotiation, and execution, as effectiveness in these areas will increase efficiency, protect researchers/sites and subjects, and help advance research.
Readability Fundamentals for Clinical Research Participant Engagement Materials	Coming Soon
Study Documentation	Outline required components of study documentation for all clinical research Define standard documentation terminology
Using Veeva SiteVault (eRegulatory Binder)	Offered by Veeva Overview of Veeva SiteVault Managing Your Profile Overview of Studies Creating & Managing Studies Study Team Assignments Monitor & Auditor Assignments Managing Study Participants Overview of Documents Study eBinder Creating and Finalizing Documents Basics of Managing Documents Managing Source Documents Managing Monitoring Reviews

	OBJECTIVES
Data Security - Information Security	Offered by CATS
Data Security - HIPAA Privacy in Research	Offered by CATS

	OBJECTIVES
Medicare Coverage Analysis	Describe processes for development of Medicare Coverage Analysis (MCA)
Clinical Trial Billing Compliance	Offered by CITI Clinical Trial Billing Compliance (CTBC) provides individuals with training on clinical research billing compliance and best practices. This includes research staff, department administrators, registration staff, billing/coding staff, and others involved in the process or who are interested in working in research billing compliance.
Budgeting for Clinical Trials	Describe processes for development & negotiation of budgets Identify the different costs associated with budget development
Clinical Trials Post-Award	Offered by Sponsored Projects Accounting