Virtual Research Administration Conference - CTRA Certificate

About the Clinical Trials Research Administration (CTRA) Certificate 

The Clinical Trials Research Administration (CTRA) Certificate delivers intensive training sessions specifically designed to provide an understanding of the critical elements of successful administration of a clinical trials research program. The program has been redesigned to cover the critical elements of clinical trials management for research administrators and to more effectively integrate with other SRAI certificate offerings.  The redesign maintains the required curriculum which introduces the student to the body of knowledge required to perform as an accomplished clinical trials research administrator.  This certificate covers broad topics that allows for its content to be well integrated with the Research Integrity certificate also offered by SRAI.

The CTRA curriculum examines issues relevant to both National Institutes of Health-sponsored and industry-sponsored clinical trials. Much of the material is explored through experiential learning activities from seasoned research administrators including case studies. Elements of the curriculum include protocol review, recruitment, negotiation of agreements, development and negotiation of budgets, compliance, billing, international studies, and risk management and analysis. These elements, along with other relevant issues, will be presented in a combination of one full-day workshop and seven sessions for completion of the program.

How to Earn the CTRA Certificate 

The Clinical Trials Research Administration (CTRA) Certificate will be offered in full at the 2024 Virtual Research Administration Conference. Attendees for this conference are eligible to receive the certificate by attending identified required and elective sessions and the pre-conference workshop. To earn Certificate credit: 

1.) Attend the identified required and elective sessions, and pre-conference workshop.
2.) Download the tracking sheets for the CTRA Certificate and fill out the tracking sheets with your information. Write “2024 RA Conference” in the space next to each session and workshop you complete. 
3.) Once all coursework has been completed email your completed documentation to sraeducation@srainternational.org to receive your certificate of completion.

Download CTRA Certificate Tracking Sheet

Certificate Program Requirements

CTRA is comprised of a two-day workshop, five required sessions and two elective sessions. The required courses are listed below; the electives will vary meeting-to-meeting.

Required Workshop

CTRA Workshop | A Guide to Clinical Trials Administration (Parts 1 and 2) 

Clinical trials are a rapidly changing field in research administration. Many of the skills needed to administer more traditional investigator-initiated, grant-funded research projects can be adapted to managing clinical trials. This teaching workshop will examine the basics of clinical trial administration from recruiting projects to archiving records, explore the differences between industry and federally funded studies, highlight special concerns and discuss best practices for managing clinical trials.

Content Level: Basic

Learning Objectives:

  1. Identify three milestones in the development of clinical research regulations and describe the importance of each.
  2. Identify three important regulatory differences between clinical research conducted in the US and in non-US/International regions

Clinical Trials Research Administration (CTRA) Certificate: Required Workshop 

Speaker(s): Bruce Steinert, Clinical Research Regulatory Manager, Medical College of Wisconsin

Required Sessions

Must take five (5).

W306: Budget Considerations – Industry Clinical Trial Agreements vs. Non-profit/Federal agreements 

You have been asked to participate in a clinical trial – what expenses would you include and at what rate? Does it matter if it is federally funded vs. industry, and can you apply the same rate? Use of FTE vs. an overall coordinator rate – study startup, how do you consider all these costs with current NIH funding levels vs. other CRO limitations.

Content level: Basic

Learning objectives:

  1. Identifying different types of costs associated with clinical trials.
  2. Discussion on various costs associated with clinical trials that are allowable on industry vs. federally funded clinical trials.

Track: Clinical and Translational

Clinical Trials Research Administration Required: Clinical Trials Budget Negotiation (CTRA-R) 

Speaker(s): Linda Dement, Grant and Finance Program Manager, Benaroya Research Institute at Virginia Mason

T105: Clinical Trials: The Industry Perspective

Description Coming Soon

T206: Introduction to Clinical Research

This session will provide an overview of clinical research administration with a focus on clinical trials.  We will examine the phases of clinical research from bench through phased research into open label studies.  Consideration of differences between federal and industry research will be discussed.
 
This session will also address the basics of clinical trials administration, from recruiting to archiving.  An introduction to major compliance guidelines will be provided- including Good Clinical Practices, Department of Health and Human Services, Food and Drug Administration, and major international regulations and guidelines, as well as other institutions governing clinical research. Participants will learn how the actions of regulatory agencies affect budget development, contract negotiations and the way studies are conducted. 
Content level: Basic
Learning objectives:
  1. Identify major types of clinical research
  2. Identify best practices for identifying areas of compliance risk

Track: Clinical and Translational Research 

Clinical Trials Research Administration Required: Rules and More Rules (CTRA-R)

Speaker(s): Lisa Weaver, Clinical Research Manager, University of Utah Health

T305: Determining All Aspects of Study Feasibility at Your Site 

This is applicable for all studies (i.e., investigator initiated, industry funded, foundation funded or federally funded). The goal is to ensuring sufficient interest in the study design and research questions. Not just doing a study to do a study. The next steps are ensure that there are proper resources (i.e., study staffing including coordinators, investigators, research assistants; Institutional Review Board (IRB) and contract review teams, statisticians, etc.) to conduct the study; proper facilities (access to investigational pharmacy; inpatient or ambulatory facilities, etc.) and equipment (centrifuge, freezers, access to specified MRI or CT equipment); and sufficient and proper patient populations. Ensure that the budget will cover the cost of implementing the study (ie. training of staffing, procedures, screening costs, development of CRFs, efforts of data transfers, monitoring, start-up costs, indirects, ect.) Determining the proper mechanism for scientific review to ensure validity of the research questions. Access to legal review through the grants and contracts team.

Content level: Intermediate 

Learning objectives:

  1. The ability to analyze the legal, fiscal, ethical and scientific review of clinical trials to ensure that you
    are choosing the right studies for your site.
  2. Is this study helpful to your patient populations (i.e. are you meeting the clinical goals important to
    your medical environment).

Track: Clinical and Translational

Clinical Trials Research Administration Required: Determining Study Feasibility at Your Site (CTRA-R) 

Speaker(s): Amy Bartlett, Associate Director, Clinical Research Development, Administrator, Trial Innovation Network Liaison OSU/NCH, The Ohio State University 

T306: Clinical Trials: The Industry Perspective 

This session will help participants fully understand clinical research from the industry perspective. The major components of the pharmaceutical industry are traditional pharmaceutical companies, stand-alone biotechnology companies, and biopharmaceutical companies that represent a melding of traditional and biotechnology approaches to discovery. In addition, there are medical device companies that, again, are either stand-alone entities or into larger pharmaceutical companies. The session will cover the industries issues with timelines, quality and cost. The presenter will provide an overview of the clinical trial protocol development process and clinical study conduct. Pharmaceutical drivers for study site selection will be highlighted. Site-based contracts, including budgets, publication rights, intellectual property, and subcontracting issues will also be discussed. 

Content level: Basic

Learning objectives:

  1. Provide pharmaceutical industry perspective in the drug development process and an overview of the steps in drug and device development.
  2. Allow participants to have an overall understanding of the issues that drive the clinical trial process and clinical trial negotiations with sites and investigators.

Track: Finance

CTRA REQUIRED: Clinical Trials: The Industry Perspective (CTRA-R)

Speaker(s): J. Michael Slocum, President, Slocum & Boddie, PC 

F102: Enhancing Public Support of Research Integrity: The Research Administrator's Role

Public trust in the scientific process and scholarly output is faltering. Research administrators and compliance professionals are uniquely positioned to help the public understand the connection between extensive regulatory requirements and research integrity. This session will facilitate brainstorming to identify specific ways that research administrators can educate the general public about the importance of research and contribute to the re-creation of public trust.   

Content level: Advanced

Learning objectives:

  1. Cite U.S. trends in public support of research.
  2. Identify actions research administrators can take to improve public trust of research among key stakeholders.

Track: Administration and Management

Clinical Trials Research Administration Required: Research Integrity (CTRA-R)

Speaker(s): Michelle Stevenson, Associate Vice President - Research Integrity, The University of Texas at San Antonio

F105: Case Studies in Research Misconduct 

The past few years has seen some high profile researchers both in the US and abroad who have fallen under scrutiny of scientific misconduct over plagiarism, falsification or fabrication.  Case studies will be used to illustrate each of these examples of research misconduct and the outcomes of investigations in to these allegations.  The session will also touch on the emerging areas of research misconduct arising from the increasing use of artificial intelligence (AI) and conflicts of interest and commitment.  

Content level: Intermediate
Learning Objectives:

  1. Identify the different types of misconduct
  2. Gain insights into potential consequences and outcomes of misconduct investigations

Track: Compliance and Ethics

Clinical Trials Research Administration Required: Research Integrity (CTRA-R)

Speaker(s): Susie Sedwick, Senior Consulting Specialist, Attain Partners 

Elective Sessions

Must take two.

Electives vary from meeting to meeting. Please reference the 2024 Virtual Research Administration Conference Tracking Sheet for the most up-to-date list of elective sessions for this conference. 

*The Certificate Tracking Sheets are subject to change. Please check the website regularly to see if any sessions have been moved, added or cancelled. If you attended a workshop or session at a previous SRAI meeting, list the meeting on the line next to the course. SRAI staff will verify your attendance at previous meetings.

Quick Links

Online Program