Onboarding & Training for Clinical Research Professionals

New hires in clinical research positions can elect to enter a New Hire Cohort with other staff hired in the same month. Each cohort will have an assigned mentor who will schedule and lead regular meetups, encourage networking activities, and provide an open space for communication. Cohorts will meet with their mentor as a group for 6 months.

Any new-hire or transfer in a clinical research role, from Clinical Research Specialist to Research Practice Manager, is welcome to join a cohort! Clinical research staff collaborate across jobs, so we think it is important to network and learn from people in a range of positions. (Estimated Time Commitment: 1-2 hrs per month)

Register yourself or an employee for the next cohort: 

New Hire Cohort Registration Form

Become a Mentor for one of the New Hire Cohorts!
Mentors will manage a Microsoft Teams channel for their assigned cohort and schedule and lead two meetups each month for at least 30 minutes. These meetings may consist of a networking activity, discussion of recent challenges, and/or chatting about any questions they have. DOCR provides a toolkit of templates and topic ideas to take some burden of planning meetup topics off the mentor. The mentor will be expected to meet with their cohort each month for at least 6 months. Bonus: you can use this experience as evidence of leadership for Tier Advancement! (Estimated Time Commitment: ~3-4 hrs a month for at least 6 months)

Mentor Nomination Form

Program Goals

1. Provide a networking and social element to new hire onboarding. Mentors will meet with their cohort of new hires bi-weekly. We encourage mentors to offer network-building opportunities at these meetings and get creative with how to make these meetings both helpful and social learning experiences. 

2. Build collaboration and community across clinical research positions. We hope that by welcoming all clinical research positions into each cohort, we can build a community of clinical research staff who understand the roles around them and can collaborate effectively. 

3. Provide a leadership opportunity for experienced clinical research staff. The mentor experience is intended to help experienced staff build or expand their leadership skills. We encourage mentors to make this opportunity their own and use this experience to grow their Tier Advancement portfolio if applicable.  

RPN+ Foundational Series sessions are a collaboration between DOCR and CRU staff to host a monthly special Research Professionals Network session on a foundational clinical research topic. These sessions are proposed and facilitated by experienced clinical research staff. Everyone in the clinical research space is welcome to attend if a topic is interesting and relevant to them. New hires are especially encouraged to take advantage of these offerings.

A full list of upcoming topics is available on the RPN Webpage.

Check out our RPN+ Microsoft Stream for a library of previous session recordings.

Facilitate a Session for the RPN+ Foundational Series!
These monthly sessions are proposed and facilitated by experienced clinical research staff. Topics might include things such as effective communication, collaborating with your PI, or SOP writing. Do you perform a certain function well or want to highlight your knowledge in an area that you think would be helpful to others? If so, submit a presentation proposal! (Estimated Time Commitment: 30 min to 1 hr facilitation, prep time may vary based on the individual and topic)

Presentation Proposal Form

RPN+ Fundamental Topic Series Goals

1. Create a community for new clinical research staff
2. Offer helpful fundamental training topics for clinical research staff
3. Provide a leadership opportunity for experienced clinical research staff

Express Start Onboarding - CRS | 00164407 | Online

Express Start for CRS and CRS Sr. consists of three self-paced e-learning courses that will provide an overview of clinical research activities, support offices, and workflows at Duke. Click here for an outline of what is included in CRS Express Start. 

Learning Objectives: 

• Describe the roles and responsibilities of a Clinical Research Specialist
• 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

Register

Express Start Onboarding Program-CRC | 00141671 | Online

Express Start for CRCs consists of four self-paced e-learning courses that will provide an overview of clinical research activities, regulations, and workflows at Duke. Click here for an outline of what is included in CRC Express Start. 

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

Express Start Onboarding Program - CRNC | 00164563 | Online

Express Start for CRNCs consists of four self-paced e-learning courses that will provide an overview of clinical research activities, regulations, and workflows at Duke. Click here for an outline of what is included in CRNC Express Start. 

Learning Objectives: 

• Describe the research role and responsibilities of a Clinical Research Nurse 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
• Define nursing responsibilities, competencies, and credentialing for the CRNC role

Register

Express Start Onboarding Program-Regulatory Coordinator | 00145771 | Online

Express Start for Regulatory Coordinators consists of four self-paced e-learning courses that will provide an overview of clinical research activities, regulations, and workflows at Duke. Click here for an outline of what is included in Reg Coordinator Express Start. 

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

Express Start Onboarding Program-RPL | 00172350 | Online

Express Start for RPL consists of five self-paced e-learning modules that should be completed by individuals hired into the RPL and RPL Sr. positions at Duke. The WE-R Express Start Onboarding modules provide new hires in clinical research roles at Duke with an understanding of the “lay of the land” of clinical research at Duke. By completing these self-paced online modules, new RPLs will learn basic information that will begin to prepare them to manage clinical research projects and programs.  

Click here for an outline of what is included in RPL Express Start. 

Learning Objectives: 

• Describe the roles and responsibilities of a RPL
• Identify the offices, programs, and resources that support clinical research at Duke
• Recognize the structure of your team and roles you can expect to interact with
• Identify the clinical research systems used at Duke and recognize how they interact with one another
• Recall best practices for becoming familiar with your clinical research portfolio of studies 
• Describe the fundamentals of project management in a clinical research context

Register

Express Start Onboarding Program-RPM/ARPM | 00155742 | Online

Express Start 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. Click here for an outline of what is included in RPM Express Start. 

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

Express Start Onboarding - CRU Director | 00168054 | Online

Express Start for the CRU Director consists of one self-paced e-learning module that will acquaint new Clinical Research Unit (CRU) Directors (also referred to as CRU Medical Director) with the structure and expectations of their role within the CRU, the responsibilities of the other roles within the CRU, support available across Duke for clinical research, and other items that are important for the CRU Director to know. The course is intended for CRU Directors or others acting in a similar capacity for a CRU. Click here for an outline of what is included in CRU Director Express Start. 

Lessons: 

1. Welcome to Your New Role (2 min)
2. Clinical Research Units and Oversight Organizations (6 min) 
3. Your Role as a CRU Director (6 min) 
4. Clinical Research Personnel Roles Within Your CRU (12 min) 
5. Clinical Research Support Offices, Programs, and Resources at Duke (15 min) 
6. Intro to Workforce Engagement and Resilience (WE-R) Initiatives (8 min)
7. Getting Started in Your Role (8 min)

Register

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 March 22, 2023

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. 

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.​

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.

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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.

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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.

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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.

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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