Clinical Research Professionals Working Group l RPL Readiness Tool

Transcription

1 Clinical Research Professionals Working Group l RPL Readiness Tool Use this tool to plan for tier advancement for Research Program Leaders at Duke who wish to move to Tier 2. 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. If tier advancement appears to be appropriate, each employee will be evaluated using standardized assessments and via committee review. It is recommended that conversations about tier advancements occur around the time of the annual performance evaluation, during discussions about professional development. Tier advancement is a separate process from performance management. Research Program Leaders are required to provide the following in support of advancement. Written descriptions of advances in the following competencies (these will all be typed directly in REDCap; prepare in advance): All 3 Portfolio + Program competency areas (*see definitions page 6) Program and portfolio oversight and management Infrastructure planning and management Program liaison and communication Optional additional portfolio/program competency if applicable All 6 Leadership competencies Any additional competencies you feel support your advancement (i.e., those for which you are at the advanced level) Please do not write about every competency only those where you have experienced notable growth and/or those considered a particular strength Two letters of recommendation from Duke faculty or other Duke leaders who support your advancement (cannot be manager) letters should acknowledge particular areas of growth, leadership, or contribution to the institution/research Submission of Work Portfolio, which may include anything the candidate feels would support advancement. Examples include: publications, recognitions, certifications, additional letters of recommendation, etc. Committees will review application materials, looking to advance candidates who exhibit: Leadership l Contribution to Research l Contribution to Institution PAGE Version: 10/3/17

2 RPL Readiness Tool Name: Core Competencies RPL Program and Portfolio Competencies Competency Program and portfolio oversight and management Infrastructure planning and management Program liaison and communication Self Assessment of Growth - Responses will be entered directly into REDCap Other Notes PAGE Version: 10/3/17

3 Other competencies Expectation for RPL Area of advancement or strength? Screening Recruitment Subject management and retention Serves as an expert to research program team members in the area of screening. May provide oversight and conduct training in this area. Serves as an expert resource for research program team members in the area of research participant recruitment. May provide oversight and conduct training in this area. Serves as an expert participant retention resource to research program team members, including liaising with and being knowledgeable about other resources at Duke. Subject-level documentation Serves as an expert to research program team members in the area of subject-level documentation. May provide oversight and conduct training in this area. Research Operations Prepare and conduct study visits Specimen collection and preparation Serves as an expert resource and trainer to research program team members for preparing and conducting study visits. May provide oversight and conduct training in this area. Creates, optimizes, and oversees the systems for managing specimens for a research program. Serves as an expert resource in specimen collection, processing, preparation, shipping and maintenance. May provide oversight and conduct training in this area. Investigational Products Study-level documentation Determining Feasibility Consent procedures (consent) Serves as an expert resource for research program team members for the proper handling of investigational product (IP). Provides expertise to research program team members in study-level documentation. May provide oversight and conduct training in this area. Collects information to determine whether the study team's participation in a specific trial is feasible. Serves as an expert consent conduct and documentation resource to research program team members, including liaising with and being knowledgeable about other resources at Duke. May provide oversight and conduct training about consent procedures. PAGE Version: 10/3/17

4 Monitoring and Audits (audit) Interactions and submissions with IRB Provides direction to multiple study teams to prepare for study monitoring or study audit visits. Independently addresses and corrects audit or monitor findings and develops relevant reports. Serves as an expert resource to research programs about interacting with IRB staff and reviewers. May be responsible for administrative review of submissions flowing through eirb. Institutional Regulatory Policies and Processes Institutional Regulatory Documentation Recognizes when regulatory and institutional policies or processes are relevant, and applies appropriately. Serves as an expert resource to the research program about developing all components for ethics review. Contracts and Agreements Recognizes when agreements are necessary within the research program and facilitates the process, by coordinating with study teams and appropriate Duke offices. Regulatory compliance with international studies Interacting with the FDA as it relates to Duke Investigator held IND/IDE Use and development of SOPs Technology Management Team meetings and management Electronic management of research participants Independently navigates conversations with foreign agencies and study teams to develop or obtain the required documentation for compliance with international regulations. May assist others with ensuring regulatory compliance with international studies. Serves as an IND submissions expert resource. Assists junior staff to address FDA review or issues. Provides oversight and guidance to those preparing documents, annual reports, and amendments required by FDA. Develops, oversees adherence, and trains on SOPs for processes across research program. Seeks out, integrates, and applies new technical knowledge towards innovation and performance improvement for research program, as relevant. Prepares for and leads research program meetings. Ensures good communication within the research program, including mentoring staff to improve communication strategies. Oversees use of systems and system reports to manage patient/participant research activities and charge routing. PAGE Version: 10/3/17

5 Ethics/Participant Safety Identification and Documentation of Adverse Events Adverse Event Reporting Ensures that research program team members are appropriately identifying and documenting adverse event information. Ensures that multiple study teams are appropriately submitting AE Reports, according to institution and sponsor-specific prompt reporting requirements. Data/Informatics Data flow Data Collection and Entry Data Security and Provenance Serves as an expert data flow resource to research program team members. Predicts areas of data flow vulnerability. Determines areas where data provenance may be compromised, and helps staff work through solutions. Ensures that staff are familiar with data flow resources at Duke. Selects and implements data capture methods appropriate for the research program. Serves as an expert in designing ECRFs and EDCs to collect data according to protocols and research program processes. Develops and implements protocols for research program that include strategies and processes to ensure data security and provenance. Serves as an expert data provenance and security resource, including liaising with and being knowledgeable about other related resources at Duke. Data Corrections, Queries, and QA Oversees the process of QA, data corrections & queries used within the research program, including creating and using QA protocols, queries, summaries and reports. Recognizes trends, and recommends strategies to improve processes or retrain staff. Serves as an expert data corrections, queries, and quality assurance resource, including liaising with and being knowledgeable about other related resources at Duke. Literature Reviews Independently reviews articles, synthesizes the literature, and uses to assist in the development of manuscripts or grant proposals. Scientific Concepts Research Design Protocol development Scholarly Publishing Provides a significant contribution to protocols or research proposals because of expertise in research design. Independently develops protocols for all studies, including those that are complex in nature. May provide oversight and conduct training in this area. Develops substantial portions of scholarly publications or presentations. Leads scientific presentations or posters at national conferences. PAGE Version: 10/3/17

6 Proposal development Independently develops substantial portions of proposals and grants. Assesses and determines solutions for operational shortcomings of proposals. Determining Participation in Trials Managing Resources Determines the ability for the research program to take on additional (externally or internally supported) projects. Make appropriate recommendations in this area. Develops and manages the research program budget and determines staffing needs. Manages and trains staff. Site & Study Management Managing Risk Site Visits and Sponsor Training Operational Plans Works with the CRU or departmental leadership to ensure that studies within the research program are conducted in compliance with institutional requirements and policies. Leads site initiation and closeout activities. Provides feedback to study team members and serves as an institutional resource to the site visitors. Ensures the appropriate development and implementation of standard operating procedures within the research program. Study Closeout Works with the CRU or departmental leadership to ensure that studies are closed according to best practices and guidelines. Program/Portfolio *Program and portfolio oversight and management *Infrastructure planning and management *Program liaison and communication Manages the program or shared resource by employing strategies to reach established short- and long-term goals. Monitors the program's success using relevant reports. Investigates trends and implements modifications to improve the effectiveness of the research program or shared resource. Manages the research program or shared resource operations. Monitors and adheres to the established budget. Manages and trains staff. Ensures that institutional communications are shared with research program staff. Maintains communication within program and with other departments or offices to accomplish the program objectives. PAGE Version: 10/3/17

7 Leadership competencies Competency Indicate how you meet or exceed Continual Learning Evaluates and implements the department, CRU, or division professional development and/or training programs to ensure they meet the needs of staff retention, continuous improvement, and development. Organizational Agility Understands the structure and processes of clinical research, and how to assemble teams from diverse Duke environment to achieve a common goal. Solves problems while ensuring Duke policy and federal laws and regulations are followed. Management & Mentorship Helps others, regardless of reporting relationship, to acquire the awareness, confidence, and resources necessary to accomplish work objectives. Establishes and assigns the activities of the research program team members to accomplish the study goals. PAGE Version: 10/3/17

8 External Awareness & Contribution Keeps current with research updates by attending key external departmental meetings (i.e., Research Wednesday, RPN, additional LMS training, etc.) and applies the learned material to the job. Disseminates information to employees or faculty. Keeps current with advances in the scientific area and considers the impact on the research program. May encourage staff to actively participate in external unit networks (i.e. Research Wednesday, RPN, networking, colloquium, etc.). Subject Matter Expertise Uses advanced subject matter expertise in the therapeutic area or clinical research to solve large problems or foster innovation within the research program. Resilience & Adaptability Demonstrates resilience and actively facilitates change within the research program. PAGE Version: 10/3/17