Onboarding and Training for Clinical Research Professionals

Competency domains of clinical research used at Duke with the competencies listed inside the graphic

Competency Based Programs:

Engagement, Recruitment, and Retention Certificate Program

The Clinical and Translational Science Institute’s Recruitment Innovation Center has collaborated with DOCR to gather a team of experts across Duke and beyond to create a certificate program focused on engaging, recruiting, and retaining clinical research participants that is free to Duke research staff.

Program Goals

  1. Develop a cohort of engagement, recruitment, and retention specialists who can serve as a resource for their clinical research units, departments, and divisions.
  2. Bolster the skills that are necessary for both meaningful and inclusive engagement, recruitment, and retention engagement practices.
  3. Help study teams think critically about participant engagement and recruitment and participant engagement from perspectives other than their own.
     

Want more information? Check out the program website.​

 


Express Start Online Modules:

Express Start is a bundle of self-paced e-learning courses, organized by role, that will help acquaint new employees to clinical research at Duke. The intention is to help new clinical research professionals get started quickly. These include an overview of clinical research activities, regulations, and workflows specific to each clinical research role.

Clinical Research Coordinator

Express Start Onboarding Program-CRC | 00141671 | Web-based offering

The Express Start Onboarding Program consists of four self-paced e-learning courses that will provide an overview of clinical research activities, regulations, and workflows at Duke.

Learning Objectives: 

  • Describe the roles and responsibilities of a Clinical Research Coordinator
  • Identify the clinical research offices and resources within Duke Health
  • Identify the clinical research systems used at Duke and understand how they interact with one another
  • Discuss the studies that make up your research portfolio
  • Describe the career progression within clinical research professions

Register

 

Regulatory Coordinator

Express Start Onboarding Program-Regulatory Coordinator | 00145771 | Web-based offering

The Express Start Onboarding Program consists of four self-paced e-learning courses that will provide an overview of clinical research activities, regulations, and workflows at Duke.

Learning Objectives: 

  • Describe the roles and responsibilities of a Regulatory Coordinator
  • Identify the clinical research offices and resources within Duke Health
  • Identify the clinical research systems used at Duke and understand how they interact with one another; with a spotlight on iRIS
  • Find and follow applicable standards, guidelines, regulations, policies, and procedures for performing clinical research at Duke
  • Describe the career progression within clinical research professions
     

Register

 

Research Practice Manager and Assistant Research Practice Manager

Express Start Onboarding Program-RPM/ARPM | 00155742 | Web-based offering

The Express Start Onboarding Program for RPM/ARPM consists of five self-paced e-learning courses that will provide an overview of clinical research activities, regulations, and workflows at Duke. By completing these modules, new CRU leaders will learn basic information that will begin to prepare them for their role as a RPM or ARPM at Duke.

Learning Objectives: 

  • Describe the roles and responsibilities of a RPM or ARPM
  • Identify the offices, programs, and resources that support clinical research at Duke
  • Recognize the structure of your team and roles you can expwct to manage and interact with
  • Identify the clinical research systems used at Duke and recognize how they interact with one another
  • Recall regulations, guidelines, and policies for conducting clinical research at Duke
  • Describe the RPM and ARPM responsibilities related to WE-R initiatives and Tier Advancement for employees

Register

 


CRP Onboarding Learning Plans:

DOCR is developing Competency-Based Onboarding Learning Plans for some Clinical Research Professional (CRP) positions at Duke. These customizable plans are being updated and improved regularly as feedback is received from managers and employees across CRUs and as new training becomes available. Access the Plans and a Manager Guide at the links below. 

Onboarding Learning Plans LinkOnboarding Manager Guide Link

PLEASE NOTE: These plans are updated regularly. Prior to beginning onboarding for a new employee, please visit the page above and download the most recent version of the learning plan to ensure links and available training are current.


Competency Training:

Click the domain below to view training for competencies within that domain. A full listing of the competencies and associated assessments can be found on the WE-R Tier Advancement page.

Research Operations Training- click here for link

Safety and Ethics Training- click here for link

Data Training- click here for link

Scientific Concepts Training- click here for link

Site and Study Management Training- click here for link


Refresher Series Training:

Courses that are created and added to the Refresher Series will provide a refresher when attending a whole course on a broad topic isn’t necessary. Each series of micro-learning courses will provide a dive into a specific concept related to the overarching topic.

 

Study Documentation

Study Documentation Refresher Series 1: Introduction to Clinical Research Documentation

This 12 to 15 minute module discusses the importance of study documentation and how to navigate different governing authorities as it relates to study documentation.

Register

Study Documentation Refresher Series 2: Study Level Documentation

This 20 to 25 minute module discusses what study level documentation is, how to maintain it, and resources for creating and maintaining a compliant regulatory binder. You’ll also learn what documents are required for different types of studies and the importance of SOPs.

Register

Study Documentation Refresher Series 3: Participant Level Documentation

This 15 to 20 minute module discusses what documents are “participant level” along with some specifics around informed consent, research data, and source data documentation. You’ll also learn how case report forms are used to report research data to the sponsor.

Register

Study Documentation Refresher Series 4: How To’s and Best Practices

This 10 to 15 minute module discussed best practices for maintaining study documentation, proper practices for notation of changes, and when a note/memo to file might be required. You’ll also hear about when a protocol deviation would require both a Note/Memo to File and reporting to the IRB.

Register

Study Documentation Refresher Series 5: Document Retention

This 10 to 15 minute module discusses how documents are retained and stored for open and closed studies as well as how regulations inform document retention requirements. You’ll also learn tips on planning for document storage and retention.

Register