Clinical Research Onboarding Learning Plans

Onboarding Learning Plan homepage image

DOCR is developing Competency-Based Onboarding Learning Plans for Clinical Research positions at Duke. These customizable plans are being updated and improved regularly as feedback is received from managers across the CRUs and as new training becomes available.

The Onboarding Learning Plans include:

  • Clean and easy access to updated training links
  • Standardized core learning
  • Customizable learning paths
  • Structured timeline with weekly themes/competencies
  • Editable document for tailoring to each employee’s needs
  • Onboarding activities to connect the dots between training and daily work
  • A starting point for continuous competency development and review

Onboarding Learning Plans by Role 

PLEASE NOTE: These plans are updated regularly. Prior to beginning onboarding for a new employee, managers should visit this page and download the most recent version of the learning plan to ensure links and available training are current. If it is the first time using these tools for a new CRP, review the Onboarding Manager Guide and/or request a meeting with the DOCR Onboarding Liaison to review the components of the learning plan.  

Most Recent Update: June 27, 2022

CRS Onboarding Learning Plan

CRS Sr. Onboarding Learning Plan

Updated Dec 20, 2021

Core Competency Learning for CRS and CRS Sr.
Competency training and engagement that is relevant to all employees in the CRS and CRS Sr. roles.

  • Express Start & CITI
  • Electronic Participant Management & System Access
  • Consent Procedures
  • Participant Level Documentation
  • Data Security & Provenance
  • Institutional Regulatory Policies and Procedures

Competency Paths for CRS and CRS Sr.
Competency training and engagement that may be relevant to some employee's in the CRS and CRS Sr. roles.

  • Consent Procedures (CRS Sr. Plan Only)
  • Recruitment
  • Data
  • Adverse Events
  • Study Closeout
  • Contracts and Agreements

CRC Onboarding Learning Plan

Updated Feb 14, 2022

Core Competency Learning for CRC
Competency training and engagement that is relevant to all employees in the CRC role.

  • Express Start & CITI
  • Electronic Management of Participants/Protocols & System Access
  • Consent Procedures
  • Participant & Study Level Documentation
  • Data Security & Provenance
  • Institutional Regulatory Policies and Procedures

Competency Paths for CRC
Competency training and engagement that is relevant to some employee's in the CRC role.

  • Recruitment & Screening
  • Data
  • Adverse Events
  • Regulatory Cores (for those with regulatory responsibilities
  • Study Closeout
  • Investigational Products
  • Specimen Management

CRNC Onboarding Learning Plan

Updated Feb 14, 2022

Core Competency Learning for CRNC
Competency training and engagement that is relevant to all employees in the CRNC role. Note that CRNCs are required to meet DUHS Nurse Credentialing Requirements and SOM Core Competencies as outlined in the CRNC Credentialing policy. The CRNC plan includes the Core Nursing Competencies and required training for SOM nurses and Clinical Research Competencies that mirror training for the CRC role.

  • Express Start & CITI
  • Required Nursing Orientation Training and Competencies for CRNC
  • Electronic Management of Participants/Protocols & System Access
  • Consent Procedures
  • Participant & Study Level Documentation
  • Data Security & Provenance
  • Institutional Regulatory Policies and Procedures

Competency Paths for CRC
Competency training and engagement that is relevant to some employee's in the CRC role.

  • Recruitment & Screening
  • Data
  • Adverse Events
  • Regulatory Cores (for those with regulatory responsibilities
  • Study Closeout
  • Investigational Products
  • Specimen Management

RC Onboarding Learning Plan

Updated Feb 14, 2022

Core Competency Learning for RC
Competency training and engagement that is relevant to all employees in the RC role.

  • Express Start & CITI
  • Electronic Management of Protocols & System Access
  • Developing the Informed Consent Doc & Plan
  • Navigating Ethics Review & Institutional Regulatory Policies and Procedures
  • Data Security & Provenance
  • Sponsor/Regulatory Reporting

Competency Paths for RC
Competency training and engagement that is relevant to some employee's in the CRC role.

  • Participant & Study Level Documentation
  • Data
  • Adverse Events
  • Contracts & Agreements
  • Study Closeout
  • FDA Regulatory Submissions

Supplemental Task-Based Checklist

Updated June 27, 2022

This task-based checklist is a template developed for use in combination with the Onboarding Learning Plan to onboard new CRPs. It includes non-training items such as technology setup, health screening, team member introductions, etc. Managers can download and modify as needed. This checklist will be periodically reviewed and updated by DOCR, but please reach out if you notice something that needs to be updated.

Please note: This is a template and may not include every item required to onboard a new employee to your specific unit. Some items may be relevant to some employees and not others. Please review and adjust as needed.  

Onboarding/Training Checklists for Leadership Roles

Onboarding for new RPMs and ARPMs is available in checklist form. Individuals can request this checklist from DOCR by completing this form. The form is used to alert DOCR of your need for the most recent checklist, and to track onboarding plan use. 

The checklist for RPMs and ARPMs includes: 

  • Suggested RPM and ARPM Training, including Express Start
  • Suggested meetings to get acquainted with clinical research support offices at Duke 
  • Access needed for RPMs and some ARPMs - and contacts/resources for that access
  • A list of specific tasks to complete as applicable to the CRU

When you receive the checklist using the form above, follow instructions for getting DOCR help with setting up necessary introduction meetings and system and reporting access for the new RPM or ARPM.

Onboarding for new CRU Directors is available in checklist form using the button below. CRU Directors can register use of the checklist and request meetings listed on the checklist using this form

The checklist for CRU Directors includes: 

  • Suggested CRU Director Online Training, including Express Start and OnCore Modules
  • Suggested introductory meetings and 1 on 1 training for CRU metrics and scorecards 
  • Access that may be needed for CRU Director - and contacts/resources for that access
  • A list of specific tasks to complete as applicable to the CRU

The CRU Director, or person preparing their checklist, should follow instructions for submitting this form to receive DOCR help with setting up necessary introduction and 1 on 1 training meetings.

CRU Director Checklist

PI Training Checklist Tool

Updated July 6, 2022

This tool, developed by DOCR in collaboration with Medicine CRU, is an editable checklist that can be used for clinical research PIs. It includes a list of LMS training, policies, and other resources. These items are mapped to learning objectives that may be relevant or helpful to PIs who are getting started or who need a refresher on certain topics. 

If you would like to suggest changes or additions to this checklist, reach out to DOCR.help@duke.edu

Onboarding Engagement Activities

In order to help employees engage with the topics/competencies covered in onboarding, we have developed onboarding activities to supplement the online and in-person courses.

Within the Onboarding Learning Plans, there are links to Engagement Activity Packets which correspond to many of the competency topics in the Plan. These guides provide desired fundamental knowledge and skills, recommended guidance and policies for review, additional available courses, and guided questions and activities to further engage the employee and their manager or mentor in the competency learning and onboarding process. These are designed to engage employees beyond the online training modules to apply learning to their daily activities.  Duke employees are welcome to download and use these tools in whatever ways they are helpful.

UPDATED 12.1.2021