Tier Assessment/Setting - Quick Guide to Competency Levels

Transcription

1 Tier Assessment/Setting - Quick Guide to Competency Levels RESEARCH OPERATIONS Competency Fundamental Skilled Advanced Interactions with IRB Candidate has used the system to successfully submit documents for at least two types of submissions (e.g., new protocol, amendment, continuing review, safety event). Candidate has used the system to successfully submit at least 4 types of submissions (e.g., new protocol, amendment, continuing review, safety event). Understands terms used within the IRB, and responds quickly and appropriately to IRB staff/chairs. Candidate is responsible for submission of multiple complex trials (Phase 1, treatment trials, or multi-site trials where Duke is the coordinating center). May be responsible for interacting with the IRB around less complex studies, but demonstrates deep understanding of the needs of reviewers, as exhibited by no missing documents/information and no additional requests from IRB. Demonstrates application of knowledge of interacting with IRB outside of individual job or assigned Contracts and Agreements Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts the study team. Recognizes when most types of agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts the study team. Recognizes when all types of agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts the study team. Demonstrates application of knowledge of contracts and agreements outside of individual job or assigned Electronic Management of Research Participants Informed Consent Procedures Institutional Regulatory Policies and Processes Interacting with the FDA Uses the system with little assistance to manage common research patient activities. Recognizes key reports to manage processes. Initial recruitment contact follows the consent plan. Candidate is able to follow the majority of the components of the consent plan unprompted Score >60% on knowledge test N/A Uses the system independently to manage all research patient activities. Effectively troubleshoots common issues. Uses reports regularly to manage processes. Follows all components of the consent plan. Demonstrates additional fluidity and skill beyond following the consent plan. Handles participant questions appropriately. Score >80% on knowledge test Prepares, submits, and maintains applications to the FDA for at least one IND, IDE, or ITP and can accurately list effective dates and reporting requirements. Can navigate complex issues independently within research systems to manage research patient activities. Demonstrates application of knowledge of electronic management of study participants outside of individual job or assigned Meets skilled competency, and demonstrates application of knowledge/skills related to consent outside of individual job or assigned Score >80% on knowledge test and provide meaningful demonstration of how they have shared their knowledge and skills with others. Prepares, submits, and maintains applications to the FDA for more than one IDE, or ITP and can accurately list effective dates and reporting requirements for each. Handles potential hold issues and escalates appropriately. Demonstrates application of knowledge of PAGE - 1 -

2 Competency Fundamental Skilled Advanced interactions with the FDA outside of individual job or assigned International Regulatory Compliance Collaborate with in-country counterparts to assist with the defined process for international regulatory approval Helps lead or define the process required for international regulatory approval. Anticipates issues related to time constraints. Performs at a skilled level and develops the processes needed for international regulatory approval and/or demonstrates application of knowledge of international regulatory issues outside of individual job or assigned Investigational Products Monitoring and Audits Has foundational understanding and skills related to provision and tracking of IP. May require some coaching or supervision. Scores>= 60% on Knowledge Assessment. Prepares documentation and participates in the audit as directed. Scores>= 80% on Knowledge Assessment. Can detect a few issues with sample IP logs. Can detect many issues with sample IP logs. Plans for the audit, provides direction to prepare for the audit, participates appropriately in the audit, and follows issues to resolution. Has strong understanding and skills related to provision and tracking of IP. Can detect almost all issues with sample IP logs. Scores>= 80% on Knowledge Assessment. Demonstrates advanced skills and knowledge and the ability to teach, coach, or supervise others. Performs at a skilled level and demonstrates application of knowledge of monitoring and audits outside of individual job or assigned Participant Recruitment Candidate demonstrates understanding of documents/resources associated with recruitment. Recruits participants independently, aware of tools and strategies to maintain expected recruitment rates, and aware of ethical/regulatory issues related to recruitment. Meets fundamental and has responsibility for developing recruitment process(es). May have responsibility for developing and implementing tools to track/report recruitment efforts. Devises solutions to recruitment challenges. Meets skilled and has responsibility for monitoring recruitment, developing recruitment processes/docs or monitoring tools, and recommending changes to recruitment processes. Demonstrate a strong understanding of best practices for engaging with special study populations, including the hard-to-reach, minorities, elderly or pediatrics. Demonstrates application of knowledge of recruitment strategies/tools outside of individual job or assigned Participant Retention Accurately describes documents or strategies used to help with participant retention, and tools/strategies used in monitoring retention. Uses participant retention strategies. Independently uses retention strategies and monitoring tools. Helps develop participant retention strategies or monitoring/reporting tools. Suggests potential solutions to retention issues. Leads or mentors others in using retention strategies. Independently develops participant retention strategies or monitoring/reporting tools. Reports participant retention rates to study team. Demonstrates application of knowledge of participant retention tools and strategies outside of individual job or assigned Regulatory Documentation Creates documents with most required features. Creates regulatory documentation (research summaries, consent forms, other key documentation) that is accurate and complete. Few edits that could have been avoided by Creates regulatory documentation in the context of complex trials (Phase 1, treatment trials, or multi-site trials where Duke is the coordinating center). May create less complex regulatory documentation, but demonstrates deep understanding of the needs of PAGE - 2 -

3 Competency Fundamental Skilled Advanced careful attention to instructions are requested from the IRB. reviewers, as exhibited by no missing information and no additional requests from IRB. Demonstrates application of knowledge of regulatory documentation outside of individual job or assigned Screening Implements screening process according to policies and guidelines, and can list the documents that define the process Responsible for determining the screening process, and escalates any screening issues as appropriate Meets skilled, and assists in determining and implementing solutions for issues related to screening. Applies competency outside of own job/tasks Specimens Completes biohazard training. Employs basic specimen collection procedures per protocol. Independently collects, processes and ships specimens per protocol, and according to all laboratory safety processes Performs at a skilled level and develops processes for specimen collection, handling or shipping. Demonstrates application of knowledge of specimens outside of individual job or assigned Standard Operating Procedures Uses SOPs and takes part in editing or maintaining SOPs Meets fundamental, and takes part in development of SOPs. SOPs include most of the appropriate elements. Develops complex SOPs independently. SOPS include all appropriate elements and are written clear and concisely. Demonstrates application of knowledge of SOP development outside of individual job or assigned Study Level Documentation Maintains study level documentation for at least one protocol with some assistance and oversight. Scores >60% on knowledge test and >70% on reviewer checklist. Maintains study level documentation independently, with no regulatory issues identified as major. Scores >80% on knowledge test and 90% on reviewer checklist. Maintains study level documentation independently for complex studies, and with no regulatory issues identified as major. Demonstrates application of knowledge of study documentation outside of individual job or assigned Scores >80% on knowledge test and 100% on reviewer checklist. Study Visits Subject Documentation Conducts study visits according to protocol, using tools provided. Responsible for subject documentation for at least one protocol, possibly with some oversight. Compliant with at least 70% of the items in the reviewer checklist Conducts visits according to protocol, using tools provided, and with fluidity and efficiency. Develops tools to optimize study visits. Independently maintains subject documentation for at least one protocol. Compliant with at least 90% of the items in the reviewer checklist, and no major concerns from OARC Conducts complicated visits according to protocol, using tools provided, and with fluidity and efficiency. Develops tools to optimize study visits and trains others in their use. Independently maintains subject documentation for complex Compliant with 100% of items in the reviewer checklist, and no major concerns from OARC. Provides documentation of applying the competency outside of own job/tasks PAGE - 3 -

4 Competency Fundamental Skilled Advanced Team Meetings Participates in meetings, schedules meetings, handles meeting documents Has role in identifying/organizing meeting agendas and demonstrates advanced meeting planning and orchestration skills. Demonstrates control of the meeting/participants and is objective-focused. Meets skilled, and demonstrates ability to encourage collaboration with meeting participants, manage difficult situations, and exhibit advanced communication skills. Demonstrates application of knowledge of team meetings outside of individual job or assigned Technology Management Uses basic software for data entry or word processing Uses a variety of software or systems efficiently. Shares efficiencies and techniques with others. Uses a variety of software or systems efficiently and demonstrates effective, innovative use of advanced features for time/project management or communication. Demonstrates innovative use of technology to accomplish a work goal. Encourages and supports others to adopt and use technology. Demonstrates application of knowledge of technology management outside of individual job or assigned PAGE - 4 -

5 ETHICS/PARTICIPANT SAFETY Competency Fundamental Skilled Advanced AE Scores > 80%. Also describes application of Identification knowledge and understanding of AE Scores > 60% on knowledge test Scores > 80% on knowledge test & identification and reporting outside of Documentation individual job or assigned AE Reporting Scores > 60% on knowledge test Scores > 80% on knowledge test Scores > 80%. Also describes application of knowledge and understanding of AE reporting outside of individual job or assigned PAGE - 5 -

6 SITE/STUDY MANAGEMENT Competency Fundamental Skilled Advanced Determining Feasibility Given contact departments or individuals, gathers the information requested. Identifies all necessary departments or individuals, gathers the information necessary to determine feasibility, and serves as primary liaison. Follows up with departments to ensure that the information is gathered in a timely manner. Assists in determining feasibility. Performs at a skilled level and provides an evaluation of whether or not the study is feasible and backs it up with the data researched. Handles feasibility assessments for complex Demonstrates application of knowledge of feasibility determination outside of individual job or assigned Managing Resources Manages resources with assistance. Manages resources independently, and may assist with determining processes for their management. Determines resources needed for study, and processes related to their management. My assist in developing budget. Demonstrates application of knowledge of resource management outside of individual job or assigned Managing Risk Ensure that at least one study is conducted in compliance with institutional requirements and other policies. May share responsibility with others. Scores >70% on reviewer checklist. Ensure that at least one study is conducted in compliance with institutional requirements and other policies. Scores >80% on reviewer checklist. Ensure that multiple studies are conducted in compliance with institutional requirements and other policies. Scores 100% on reviewer checklist. Provides documentation of instance(s) where the competency has been applied outside of the individual's job tasks. Operational Plans Follows operational plans for research protocols, and helps develop workflows for participation within the scope of the protocol. Develops and follows detailed operational plans for study research protocols. Develops and follows detailed operational plans for complex study research protocols that require coordination of multiple units or services. Demonstrates application of knowledge of operational plans outside of individual job or assigned PAGE - 6 -

7 Competency Fundamental Skilled Advanced Site visits Participates in meetings with study monitors. Prepares materials needed for external meetings, as requested by monitor. Prepares information needed for site visits. Ensures that the required topics are covered. Manages the time and topics of the meetings and other site visit activities efficiently. Performs at the skilled level and demonstrates application of knowledge of site visits outside of individual job or assigned Study Closeout Assists with tasks involved in study closeout (e.g., preparation of documents and data for long-term storage, sponsor-specific documentation). Responsible for tasks involved in study closeout (e.g., preparation of documents and data for long-term storage, sponsor-specific documentation). Facilitate other closeout processes. Coordinate and execute financial, sponsor-specific, documentation, and human subjects closeout procedures for studies that involve multiple groups and/or multi-site trials. Demonstrates application of knowledge of study closeout outside of individual job or assigned PAGE - 7 -

8 DATA/INFORMATICS Competency Fundamental Skilled Advanced Corrections, QA & Queries Addresses queries, maintains documentation, and implements data quality procedures (with guidance or independently). If issues are identified, candidate escalates to others Addresses queries, maintains documentation, and implements data quality procedures (all independently); Assists with developing procedures for data quality improvement; Detects patterns of data errors and escalates as appropriate Meets skilled competency, and plays a role in identifying or developing a process that led to (or could lead to) improved data quality and efficiency. Demonstrates application of knowledge of data corrections/queries/qa outside of individual job or assigned Data Entry and Collection Completes proper data collection/entry training; Accurately enters and/or collects data according to protocol, and within timelines Accurately enters and/or collects data according to protocol, and within timelines. Assists with development of data collection SOP or plan, develop of CRFs. May provide input into RDSPs Meets skilled requirements, and assists others with data collection/entry. Independently develops data collection plan/sop, CRFs, and may assist or train others in these tasks. May assist with building data entry forms in EDC system. Identifies and implements systems to improve efficiency or accuracy of data collected or entered. Data Security and Provenance Scores > 60% Scores > 80% Scores > 80%. Also describes application of knowledge and understanding of data security and provenance outside of individual job or assigned Mapping Data Flow Can map the data flow of most components for simple research Can map the data flow of most components for research studies of moderate complexity. Asks appropriate follow-up questions when information is not provided. Can successfully map the data flow components for research studies of high complexity. Asks appropriate follow-up questions when information is not provided. Demonstrates application of knowledge of data flow outside of individual job or assigned PAGE - 8 -

9 SCIENTIFIC CONCEPTS Competency Fundamental Skilled Advanced Literature Reviews Identifies search terms, knows basic tools and databases, and provides articles to the PI Narrows searches to those articles most related to the topic. Keeps track of articles found, uses strategies to identify key papers. Identifies overall trends in published articles, and papers that may negate the hypothesis. Brings special considerations to the PI s attention Proposal Development Edits or refines sections of research proposals With little assistance, contributes to the development of draft sections of proposals. Independently contributes to the development of several sections of research proposals. Participation significantly contributes to a higher quality proposal. Protocol Development Scores 60% on knowledge test. Using scientific proposals from the PI, develops protocols for non-complex studies with some guidance. Scores 80% on knowledge test. Using scientific proposals from the PI, develops protocols for non-complex studies independently. Scores 80% on knowledge test. Using scientific proposals from the PI, develops protocols for noncomplex studies independently. Provides documentation of instance(s) where the competency has been applied outside of the individual's job tasks. Research Design Scores at least 60% on knowledge test. Scores at least 80% on knowledge test. Scores at least 80% on knowledge test and demonstrates application of knowledge of research design outside of individual job or assigned Scholarly publishing N/A Participates as co-author on poster or publication. Leads the poster or publication authorship. LEADERSHIP PAGE - 9 -

10 Competency Fundamental Skilled Advanced Continual Learning Completes required training. Recognizes opportunities for own growth, take responsibility to increase skill or knowledge level. Actively seeks opportunities to increase skill or knowledge level for self and shares opportunities with others involved in clinical research. Seeks feedback from others and uses other sources of information (e.g., professional organizations, publications) to identify appropriate areas for learning. External Awareness Regularly attends key events to remain informed Attends a variety of events to remain informed. Applies information on the job. Meets skilled, and takes action to ensure that others in the unit are aware of information/happenings outside of unit. Organizational Agility Has a basic understanding of which Duke organizational areas and individuals to contact to get things done. Works independently with Duke organizational areas and individuals to get things done. Individuals report a good working relationship. Works independently with Duke organizational areas and individuals to get things done, including issues that require complex coordination and understanding. Individuals and groups consistently report an excellent working relationship. Resilience and Adaptability Adapts to operational change with positivity and receptivity. Approached change with flexibility, and helps others in their ability to adapt. Meets skilled, and play a role in deescalating or handling difficult situations. May be responsible for leading change Subject Matter Expert N/A Exhibits subject matter expertise that was used to enhance research operations within the study team, department or unit. Exhibits expertise that was applied outside of the candidate s unit. Can include contribution outside of the institution. Teamwork Provides the information, communication, cooperation, and support necessary for the study team/department/cru to function effectively. Works with the team to solve problems as identified. Provides the information, communication, cooperation, and support necessary for groups outside your study team/department/cru. Considers "what if" scenarios in response to issues to help facilitate the best solution. Provides direct supervision or performance support. Recognizes opportunities for improvement and creates and leads teams to meet those objectives. PAGE