Onboarding & Training for Clinical Research Professionals

RPN+ New Hire Cohorts and Onboarding Topic Series

RPN Plus Graphic with new hire cohorts and onboarding series icons

New hires in clinical research positions can elect to enter a New Hire Cohort with other staff starting 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 for 6 months with their cohort and mentor.

Any new-hire or transfer in a clinical research role, from Clinical Research Specialist to Research Practice Manager, can 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

Cohort Signup Timeline Example

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. 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 and expertise 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 a group of new hires bi-monthly. 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. We hope that the mentor experience helps experienced staff to build or expand leadership skills. We encourage mentors to make this opportunity their own and use this experience to grow their Tier Advancement portfolio if applicable.  

RPN+ Onboarding Series sessions are a collaboration between DOCR and CRU staff to host a monthly special Research Professionals Network session on an introductory 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. Staff hired in the past year are 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 Onboarding 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 new clinical research staff? 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+ Onboarding Series Goals

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

 

 

RPN+ Session Recording Stream

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. Express Start is listed as the first step in the Onboarding Learning Plan tool for a role.

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 | 00155742 | 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

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.

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

The Competency Training page includes training for competencies within each of the domains below. Click on a domain to find training that has been mapped to that topic on the Competency Training page. A full listing of the competencies and associated assessments can be found on the WE-R Tier Advancement page.

Competency Based Programs

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.​

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 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