Workforce Engagement and Resilience

To achieve the vision of advancing health and executing a coordinated strategy in clinical research to evolve the model of care outcomes.

The Workforce Engagement and Resilience group utilized the work of the Joint Task Force for Clinical Trials Competency (JTFCTC), which had recently developed draft competencies for research professionals, to create a framework for clinical research jobs at Duke.  The competencies are used as the foundation to help managers select titles for new positions, and provide professional development and career advancement opportunities.  School of Medicine leadership truly believe that a strong workforce of clinical research professionals will enable higher quality research and ultimately lead to better patient care and health outcomes.
(Illustration https://www.clinicaltrialcompetency.org/)

 

The competency domains for the clinical research professional created by the Joint Task Force (JTF) for Clinical Trial Competency. This wheel is broken up into eight competency domains. These domains are as follows:

  1. Scientific concepts and research design
  2. Ethical and participant safety considerations
  3. Investigational products development and regulation
  4. Clinical study operations (GCPs)
  5. Study and site management
  6. Data management and informatics
  7. Leadership and professionalism
  8. Communication and teamwork

 

Where are we now with the initiative?

We have defined the Tier Advancement process that will allow for career progression and growth in research staff. We are now working to incorporate the competencies into training opportunities. As of August 2018, we have successfully completed a full cycle of Tier Advancement and are in the process of closing out a second. During the first cycle of Tier Advancement we had 30 coordinators complete the process and 7 Research Program Leaders. Of those staff members, between 70-75% successfully achieved their target tier.

 

ACRP Blogs

Professional Pathways Boost Staff Retention in Clinical Research Settings 
Competency Standards Key to Elevating Clinical Trial Profession
Duke Attracts and Retains Top Candidates with Competency-Based Job Descriptions

Job Classifications

 

 

 

Job titles, codes, and descriptions

The following job classifications are intended for those working in clinical research at Duke. If you intend to create a new position, please remember to request a competency-based title picker from wer-jobs@duke.edu.

 

Title Code
Clinical Research Specialist 0802
Clinical Research Specialist, Sr. 0803
Clinical Research Coordinator 1201
Clinical Research Coordinator, Sr. 1202
Clinical Research Nurse Coordinator 1203
Clinical Research Nurse Coordinator, Sr. 1204
Regulatory Coordinator 1219
Regulatory Coordinator, Sr. 1220
Research Interventionist 1243
Research Program Leader 1280
Research Program Leader, Sr. 1281

Create or Reclassify a Job

 

Creating and reclassifying positions

In order to create a new clinical research position (or reclassify an existing employee into a new clinical research position), please us the process below.

  • The hiring manager (or person most knowledgeable about what the new hire will do) should email wer-jobs@duke.edu to request a title picker survey.
  • The hiring manager will receive a single-use link to complete.
  • Once the hiring manager completes the “title picker” survey, it is routed to WE-R for review and match with the best job classification.
  • The hiring manager, HR/business manager, and RPM (if appropriate) will receive the results within 5-7 business days upon survey completion. In this email, the hiring manager will receive:
    • Title
    • Job code
    • A job description generated from the tool
  • The hiring manager may decide to update the job description as needed for posting.
  • The rest of the hiring process is the same as the normal hiring process. Note that the hiring manager must still complete the JAQ, with % of time spent in major responsibilities.

 

When do we complete the job classification selection tool (AKA “title picker”)?

  • New position
    • If you have a new position you need to create and post, please ask the RPM or the hiring manager designated by the RPM to send an email to wer-jobs@duke.edu to request a questionnaire to complete.
    • While the picker provides a template job description, job analysis questionnaire (JAQ) percentages will still need to be added by the hiring manager before posting.
    • Once you have the results from the title picker, you can proceed with creating a new position as you would normally do through iForms and the posting process through BrassRing. Please ensure that you include the record number of the picker in the comments section in iForms.

 

  • Reclassification of a filled position
    • If you want to request a review of the position (ex: the individual may fit into a different job code), please ask the RPM or the RPM designee to send an email to wer-jobs@duke.edu. The RPM or designee should request a link for a title picker for a reclassification.
    • Once you have the results from the title picker, you can proceed with creating a new position as you would normally do through iForms and the posting process through BrassRing.
    • Please be sure to complete the rate and schedule change iForm to pull the change in job code to the employee record and remove or change the tier record as appropriate.

 

  • Fill or reclassify a vacancy
    • If the position is vacant and you would like to post for hire, please make sure the position has been reviewed via a title picker within 1 year of the date the previous title picker results were sent by WE-R. If so, you can proceed to reposting the position and hiring. If this position has not been reviewed via receiving title picker results within the last year, a new title picker will be required, and can be requested through wer-jobs@duke.edu.
    • If the position is vacant and you would like to reclassify the position based on a change in business need, a title picker will need to be completed. Make this request by emailing wer-jobs@duke.edu.

 

Clinical Research Hiring Optimization Team (HOT)

Hiring Optimization Team (HOT) image

The Hiring Optimization Team (HOT) has been developed to streamline the workflow of hiring clinical research employees at Duke. The goal of HOT is to decrease duplicate efforts across hiring teams, have a high level understanding of best fit candidates, and decrease time to hire.

A central team is continuously reviewing candidates who apply to a single Point Requisition* for each position. As requests come in, the team works with the hiring manager to determine position needs. (Please note that a position must be opened via the Title Picker and departmental HR prior to requesting HOT services.) Best fit candidates will be provided to the hiring manager to conduct interviews.

If you have an interest in partaking in the pilot for this initiative, please reach out to CR-HOT@dm.duke.edu.

For more detail, please view the Hiring Manager Checklist and the HOT Workflows Diagram.

A clinical research employee is defined as belonging to one of the following job classifications:

  • 0802- Clinical Research Specialist
  • 0803- Clinical Research Specialist, Sr.      
  • 1201- Clinical Research Coordinator        
  • 1202- Clinical Research Coordinator, Sr.
  • 1203- Clinical Research Nurse Coordinator           
  • 1204- Clinical Research Nurse Coordinator, Sr.   
  • 1219- Regulatory Coordinator   
  • 1220- Regulatory Coordinator, Sr.            
  • 1280- Research Program Leader
  • 1281- Research Program Leader, Sr.
  • 1045- Assistant Research Practice Manager
  • 1029- Research Practice Manager

 

*Point Requisition: The requisitions managed by the HOT team that candidates apply to on the Duke HR website.

 

Job Policies, Guidance and Forms

Offer Letter Template - Template may be utilized for any of the CRU job classifications listed above.

ACRP Hiring Guidelines for Entry Level Clinical Research Coordinators - ACRP has developed helpful guidelines for those managers who hire into clinical research positions

Tier Advancement Process

 

Important Updates for Tier Advancement

Beginning in February of 2020 Tier Advancement will be offered once annually. Please see the updated timeline below. Employees may complete assessments, and managers may score them, at any time during the year.  Proctored testing is held only during the tier advancement cycles. Managers are encouraged to use the assessments as tools for onboarding, training, and evaluating staff performance.

WE-R Annual Tier Advancement Timeline

 

Cycles of Tier Advancement

Currently, CRU tier advancement opportunities are offered twice per year as reflected in the timelines below. Employees may complete assessments, and managers may score them, at any time during the year.  Proctored testing is held only during the tier advancement cycles. Managers are encouraged to use the assessments as tools for onboarding, training, and evaluating staff performance.

Fall Effective Decision Cycle October 2019

Spring Effective Decision Cycle March 2020

Eligibility (official policy can be found here)

Staff mapped into, or hired into, any of the four classifications below may be eligible:

  • Clinical Research Coordinator (1201)
  • Clinical Research Nurse Coordinator (1203)
  • Regulatory Coordinator (1219)
  • Research Program Leader (1280)

 

These staff are eligible if they:

  • Have not reached the top tier for the classification (Tier 3, except in the case of Research Program Leader, which is Tier 2).
  • Have not received an overall “Needs Improvement” on their most recent performance appraisal or mid-year review (if applicable) prior to announcing intent to go through tier advancement.
  • Appropriate parties believe the candidate is ready for tier advancement.  Appropriate parties may include faculty, managers, and those in human resources – those who are associated with the professional development of the clinical research staff member.

 

Process Overview

  • The RPM will be responsible for completing a REDCap survey for each employee applying for tier advancement. The link to complete this survey can be located on the RPM Wiki.  It is the department/center/institute’s responsibility to ensure appropriate parties (faculty, HR, others) are included in the conversation about whether an employee is ready for advancement.
  • WE-R will contact employees participating in tier advancement. Employees will:
    • Complete a survey to record the competencies and level at which they would like to be tested.
    • Drive the process and complete assessments in a timely manner.
  • The manager will:
    • Review the employee’s survey submission and make necessary adjustments.
    • Review with the employee the list of assessments that will need to be completed.
    • Conduct and score relevant assessments.
    • Input the results of employee assessments by the cycle due date.  We strongly encourage early submission to allow WE-R ample time to review for accuracy and completeness.
  • WE-R will:
    • Input scores from centrally-reviewed and proctored assessments.
    • Confirm final point tally.
    • Convene committees for review of applications for staff advancing to Tier 3 (CRC, CRNCs, and Reg Coordinators) or those advancing to Research Program Leader Tier 2; input outcome of committee meetings.
    • Communicate employee results to the department/center/institute RPM in September or February (determined by cycle).It is the department/center/institute’s responsibility to share the results with the employee.

 

Tiering Results & Salary Implications

Staff and their managers will be notified of results of their testing in February or September, with an expected effective date of March 1st or October 1st. The salary increases will be as follows:

  • 3% for advancement to Tier 2
  • 5% for advancement to Tier 3, or for those advancing from a Research Program Leader Tier 1 to Research Program Leader Tier 2

 

Tier Advancement Tools and Assessments

 

Welcome Packets

These documents provide employees and managers with a comprehensive look at the tier advancement process.

Employee Welcome Packets

CRC, CRNC, and Regulatory Coordinator Welcome Packet
Research Program Leader Welcome Packet

Manager Welcome Packets

Manager of CRC, CRNC, and Regulatory Coordinator Welcome Packet
Manager of Research Program Leader Welcome Packet

 

Sign Up for Office Hours

Virtual Office hours for WE-R Tier Advancement will be held every Monday (with the exception of Holidays), 12PM-1PM, from May 6 to July 8. We will speak individually with people who have questions; please prepare your questions in advance. To sign up for a 15 minute slot, click this link. Sign up for Office Hours. A WE-R team member will call you during your designated time. If you become unavailable during your selected time, please contact WER-jobs@dm.duke.edu.

 

Readiness Tool

Use this tool to plan for Tier Advancement for clinical research job classifications at Duke. This is to be used by employees and their supervisors, faculty, and HR managers to decide whether tier advancement is appropriate. Note – this is a self-assessment tool. Candidates applying for Tier 3, and Tier 2 for RPLs, will also receive committee review of their application.  

CRC, CRNC, and Regulatory Coordinator Readiness Tool
Research Program Leader Readiness Tool

 

Assessments

 

All Assessments and Scoring Guides

This tool is a compilation of all assessments and scoring guides.

Below are the assessments for tier advancement. If you have questions, please contact wer-jobs@duke.edu.

Note: * This is a proctored assessment and learning objectives are provided below.

 

Research Operations

 

Competency assessment or guideline
Scored by
Mode of testing

Contracts and Agreements *

WE-R Case Study

FDA Regulatory Submissions

Manager Self-Report

Institutional Regulatory Policies and Processes *

WE-R Knowledge

International Regulatory Documentation

Manager Self Report

Investigational Products *

WE-R Knowledge

Monitoring and Audits

Manager Self Report

Participant Level Documentation

Manager Self Report

Participant Retention

Manager Self Report

Recruitment

Manager Self Report

Screening

Manager Self Report

SOPs

Manager Self Report

Specimen Management

Manager Self Report

Study Level Documentation *

WE-R Knowledge

Study Visits

Manager Self Report

Team Meetings

Manager Self Report

 


Safety and Ethics

 

Competency assessment or guideline
Scored by
Mode of testing

Adverse Events *

WE-R Knowledge

Consent Procedures

Manager Direct Observation

Development of Informed Consent Doc and Plan *

WE-R Knowledge

Navigating the Ethics Review Process (IRB)

WE-R QA

Sponsor/Regulatory Reporting *

WE-R Knowledge

 


Data

 

Competency assessment or guideline
Scored by
Mode of testing

Data Collection and Entry

Manager Self Report

Data Quality Assurance

Manager Self Report

Data Security and Provenance *

WE-R Knowledge

Mapping Data Flow *

WE-R Case Study

Technology Use and Innovation

Manager Self Report

 


Scientific Concepts

 

Competency assessment or guideline
Scored by
Mode of testing

Funding Proposal Development

Manager Self Report

Literature Reviews

Manager Self Report

Protocol Development

Manager Self Report

Research Design *

WE-R Knowledge

Scholarly Works

Manager Self Report

 


Site and Study Management

 

Competency assessment or guideline
Scored by
Mode of testing
Coordination with Sponsor/CRO Manager Self Report

Electronic Management of Research Participants

WE-R Knowledge

Feasibility

Manager Self Report

Managing Resources

Manager Self Report

Managing Risk

Manager Self Report

Operational Plans

Manager Self Report

Study Closeout

Manager Self Report

 


Expert/Senior and Other

 

Competency assessment or guideline
Scored by
Mode of testing

Expert/Senior

Manager Self Report

**Other

Manager Self Report

 

**Employees may only test for one “Other Competency”. Employees and managers will alert WE-R to the chosen “other competency” via a separate process, using this survey: Other Competency REDCap Survey. This survey will need to be completed with both manager and employee present no later than May 22nd to be considered for approval. You will receive an email from WER-jobs@duke.edu with a final determination by May 29th.

 


Competency assessments for RPLs

Complete this template, upload into your Box folder

Leadership assessments for RPLs

Complete this template, upload into your Box folder

Leadership assessments for CRCs, CRNCs, Reg Coordinators seeking Tier 3

Complete this template, upload into your Box folder

 

Guidelines for Portfolio Submissions

Cover page for RPLs
Guidelines for RPLs
Cover page for CRC, CRNC, Reg Coordinators seeking Tier 3
Guidelines CRC, CRNC, Reg Coordinators seeking Tier 3

 

Training

Training for Tier Advancement

 

Tier Advancement Overview Training

Register

 

Training for managers

(Focus: Tier advancement process, Scoring assessments).

Training for staff

(Focus: Conversations with my manager, Tier Advancement process).

 

Shareable Tools

 

Mapping Tool

Duke mapped incumbent employees into new clinical research job classifications. This is being done with the use of a tool developed in REDCap. In the instructions document below, we describe how to use the tool to collect employee report of job responsibilities and competencies, and how the manager will review and edit the employee’s report. The document also describes how to create a report for each employee that summarizes the information from the employee and manager REDCap tool for review.

Mapping Tool Instructions
Mapping Tool Data Dictionary - *Please note: When the data dictionary is downloaded, it needs to be saved as a CSV file in order to be uploaded into REDCap
Mapping Summary Data
Mapping Summary Sample: Jane Doe
Mapping Summary Mail Merge

 

Title Picker Tool

Duke has developed a tool to ensure that hiring into clinical research positions is consistent. The title picker tool allows the person that best understands the job responsibilities for the position being requested to complete a survey. The survey is submitted and a committee convenes to provide a title that best fits the job responsibilities reported. The results are sent to the requester within three business days for the Human Resources managers to process and open the position.

Title Picker Data Dictionary - *Please note: When the data dictionary is downloaded, it needs to be saved as a CSV file in order to be uploaded into REDCap
Title Matching Summary Report
Title Matching Mail Merge
Job Description Data
Job Description Mail Merge
Title Picker Guidance Document