Recent Updates
Publication: Deeter, C., Hannah, D., Reyes, C., Mack, M. E., Stroo, M., Freel, S. A., ... & Snyder, D. C. (2020). Professional Development for Clinical Research Professionals: Implementation of a Competency-Based Assessment Model. Journal of Research Administration, 51(2), 15-40.
Cycles of Tier Advancement
Tier Advancement is offered once annually. 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.
Staff in the Coordinator or Clinical Data Manager positions are required to obtain:
- 36 points to achieve Tier 2
- 84 points plus pass successful committee review of their portfolio to achieve Tier 3
Staff in the Research Program Leader positions are required to:
- Pass successful committee review of their portfolio to achieve Tier 2
Eligibility
(official policy can be found here)
Staff mapped into, or hired into, any of the five classifications below may be eligible:
- Clinical Research Coordinator (1201)
- Clinical Research Nurse Coordinator (1203)
- Regulatory Coordinator (1219)
- Clinical Data Manager (1334)
- 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 serving as the Single Point of Contact (SPOC; official policy can be found here) and completing a REDCap survey for each employee applying for Tier Advancement. The link to complete this survey can be located on the RPM Teams Group. 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 into REDCap by the cycle due date. We strongly encourage early submissions.
- 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, Reg Coordinators, and CDMs) or those advancing to Research Program Leader Tier 2; input outcome of committee meetings.
- Communicate employee results to the department/center/institute RPM in October. 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 September, with an expected effective date of November 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
Welcome Packets
These documents provide employees and managers with a comprehensive look at the Tier Advancement process.
Employee Welcome Packets
CRC, CRNC, CDM, and Regulatory Coordinator Welcome Packet
Research Program Leader Welcome Packet
Manager Welcome Packets
Manager of CRC, CRNC, CDM, 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 March 8 to June 28. 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, CDM, and Regulatory Coordinator Readiness Tool
Research Program Leader Readiness Tool
Assessments
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 | Knowledge |
| FDA Regulatory Submissions | Manager | Self-Report |
| Institutional Regulatory Policies and Processes * | WE-R | Knowledge |
| International Regulatory Documentation | Manager | Self Report |
| Investigational Products * | WE-R (+ Manager for Advanced Self-Report) | Knowledge (+ Self-Report for Advanced Only) |
| 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 Handling | Manager | Self Report |
| Study Level Documentation * | WE-R (+ Manager for Advanced Self-Report) | Knowledge (+ Self-Report for Advanced Only) |
| Study Visits | Manager | Self Report |
Safety and Ethics
| Competency assessment or guideline | Scored by | Mode of testing |
|---|---|---|
| Adverse Events * | WE-R (+ Manager for Advanced Self-Report) | Knowledge (+ Self-Report for Advanced Only) |
| Consent Procedures | Manager | Direct Observation |
| Development of Informed Consent Doc and Plan * | WE-R (+ Manager for Advanced Self-Report) | Knowledge (+ Self-Report for Advanced Only) |
| 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 |
| Data Sharing * | WE-R | Knowledge |
| Data Standards and Common Data Elements * | WE-R | Knowledge |
| Mapping Data Flow * | WE-R | Case Study |
| Innovative Technology Use | Manager | Self Report |
| Programmatic Data Management and Cleaning * | WE-R | Knowledge |
| Programmatic De-identification * | WE-R | Knowledge |
| Return of Results | Manager | Self Report |
| Study Metrics for Team and Stakeholders | Manager | Self Report |
| Validation and Testing * | WE-R | Knowledge |
| Qualitative Data Analysis | Manager | Self Report |
| Quantitative Data Analysis | 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 (+ Manager for Advanced Self-Report) | Knowledge (+ Self-Report for Advanced Only) |
| Electronic Management of Research Protocols * | WE-R (+ Manager for Advanced Self-Report) | Knowledge (+ Self-Report for Advanced Only) |
| 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 by the employee and confirmed by the manager no later than March 29th to be considered for approval. You will receive an email from WER-jobs@duke.edu with a final determination by April 2nd.
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, CDMs, and 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 CRCs, CRNCs, CDMs, and Reg Coordinators seeking Tier 3
Guidelines CRCs, CRNCs, CDMs, and Reg Coordinators seeking Tier 3
Training for Tier Advancement
Training for All Staff and Managers
| Tier Advancement Overview This course will provide an overview of the Tier Advancement process and tips on navigating the Duke Office of Clinical Research Workforce Engagement and Resilience (WE-R) web page to access important tools and resources available. | Register |
| Self-Report Assessments: Overview and Scoring Guide This self-guided course provides a detailed look at the manager-scored Self-Report Assessments used during the Tier Advancement process for clinical research professionals at Duke. This course is intended for managers and employees, to understand how the form is completed by employees, and how the form is used by the manager to assess competency level and provide a final score. | Register |
| Building Your Portfolio for Tier Advancement The information in this course will help Duke Clinical Research Professionals (CRC, CRNC, CDM, Reg Coordinators, and RPL) prepare a portfolio for Tier Advancement into the highest tier for their role. | Register |
| Employee Tips for Advancement Success This session for tiered staff will provide tips and strategies for successfully navigating the Tier Advancement process with your manager. Topics that will be covered include: how to reduce the time burden for you and your manager, how to strategize competency and level selection to maximize opportunities for success, how to complete assessments, portfolio considerations, and the manager’s and employee’s distinct roles in the Tier Advancement assessment submission. Time for specific questions and answers will be available as well. | View Slides |
| Tips on Navigating Tier Advancement From a CRC II and Manager Perspective This session was presented by Laura Van Althuis, Clinical Research Coordinator II and Diane Bresch, Research Practice Manager, on February 15, 2024 for the Research Professionals Network. Laura and Diane describe tips for the Tier Advancement process from a CRC and manager perspective. |
Training for Managers and Leaders
| Difficult Conversations: Tier Advancement Guide for Managers This course will provide Duke Clinical Research Managers with resources, best practices, and communication tips for potentially difficult conversations they may face before, during, and after the Tier Advancement process. | Register |
| Manager Tips for Advancement Success This session for managers provides tips and strategies for successfully navigating the Tier Advancement process with your employee. Topics that are covered include: how to reduce the time burden for yourself and your employee, how to strategize competency and level selection to maximize opportunities for success, and the manager’s and employee’s distinct roles in the Tier Advancement assessment submission. | View Slides |
| RPM/ARPM Overview of WE-R Initiatives and Tier Advancement Responsibilities This course will introduce new RPMs and ARPMs to responsibilities related to WE-R initiatives and the tier advancement process as a whole. This module is included in RPM/ARPM Express Start. | Register |