This page houses Competency-Based Onboarding Learning Plan templates for Clinical Research positions at Duke.
The Onboarding Learning Plan templates include:
- Access to updated training links and context for training modules
- Standardized core learning
- Customizable learning paths
- Structured timeline with weekly themes/competencies
- Editable template for tailoring to each employee’s needs
- Suggested shadowing and manager review questions to connect the dots between training and daily work
- A starting point for continuous competency development and review
Onboarding Learning Plan Templates
PLEASE NOTE: These templates 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 consultation with the DOCR Onboarding Liaison to review the components of these templates and how to incorporate them into your current onboarding practices.
Most Recent Update: 12/12/2023
We review and update these as often as possible. If you encounter any broken links in these templates please let us know using this form.
CRS Sr. Onboarding Learning Plan
Updated October 31, 2023
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
Updated November 9, 2023
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
Updated November 9, 2023
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
Updated October 31, 2023
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
Updated October 31, 2023
If you use or review this plan and are willing to provide feedback or suggestions for improvement, complete this survey.
Core Competency Learning for RPL
Competency training and activities that is relevant to most individuals in the RPL role.
| Domain | Competencies Covered |
|---|---|
| Express Start & CITI | Getting Started with required training items and an introduction to the RPL role. |
| Systems for Management of Research Participants and Protocols | OnCore, Maestro Care, iRIS |
| Operational Leadership | Regulations, Policies, & Resources | Lead Project/Program Staff | Budgeting & Resource Management | Communicate to Accomplish Program Objectives |
| Project Management | Initiating Projects & Managing Scope | Project/Program Planning | Stakeholder Management | Task Scheduling & Management | Milestone Tracking & Status Reporting |
| Intellectual Contribution & Scientific Concepts | Proposals, Grants, Protocols, & Manuscripts | Representing the Program |
| Leadership & Professionalism | Professional Development | External Awareness & Contribution | Organizational Agility, Resilience & Adaptability | Subject Matter Expertise & Problem Solving | Teamwork |
Competency Paths for RPL
Competency training and engagement that is relevant to some employee's in the RPL role.
| Domain | Competencies Covered |
|---|---|
| Research Operations | Contracts and Agreements | Investigational Products |Study Documentation | Study Participant Recruitment & Retention | Monitoring & Audits |
| Safety and Ethics | Adverse Events | Informed Consent | Navigating the Ethics Review Process | Sponsor/Regulatory Reporting |
| Data | Data Security & Provenance | Data Collection & Entry |
| Site and Study Management | Coordination with Sponsor/CRO | Study Closeout |
Clinical Research Intern Learning Plan
Updated December 12, 2023
This learning plan houses required training for interns as outlined in the DOCR Process for Adding Duke Students, Unpaid Volunteers, and External Trainees/Interns to Study Personnel. In addition to required training, the document houses other online training opportunities that can be used to supplement an intern's hands-on learning experiences with the study team. This document was created in collaboration with the CTSI to support the Clinical Research Internship Portal (CRISP).
The learning plan outlines:
- Required training interns must complete before beginning internship activities
- Recommended online training for Students/Interns to supplement their hands-on learning experience
- Additional helpful learning experiences for intern down-time
- Guide for documenting training requirements
Supplemental Task-Based Checklist
Updated October 19, 2023
This task-based checklist is a template developed for use in combination with the Onboarding Learning Plan templates 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.
Note: Onboarding checklists for leadership roles, including Research Practice Managers, Assistant Research Practice Managers, and CRU Directors, are available on this page.
Onboarding Engagement Activities
These include: manager review questions and suggested shadowing activities to help employees apply what they learn in the online and in-person courses.
Within the Onboarding Learning Plan templates, 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, guided manager review questions, and suggested shadowing 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. If you encounter any broken links in these packets please let us know using this form.
- Adverse Events
- Consent Procedures
- Contracts and Agreements
- Data Security and Provenance
- Development of Informed Consent Doc and Plan
- Electronic Study Management
- Institutional Regulatory Policies and Procedures
- Investigational Products
- Recruitment and Screening
- Study Closeout
- Study Documentation
- Leading Project and Program Staff – Research Program Leader
- Budgeting and Resource Management – Research Program Leader
- Project Introduction, Initiation, and Scope Management – Research Program Leader
- Project Planning – Research Program Leader
- Communication Planning and Stakeholder Management – Research Program Leader
- Task Scheduling and Management – Research Program Leader
- Intellectual Contribution – Research Program Leader
Sunita: New to Duke and Clinical Research
Juan: Transfer from Another Duke CRU