Core Competency Framework for CRA （3/3）(值得收藏)

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Domain: Clinical Trial Operations (GCPs).

Competency: IP Blinding and Randomization

Expectation: Verifies integrity of blind and randomization process.

Entry-Level Monitor: Verifies integrity of blind, adherence to stratification and randomization process. Identifies reporting procedures for accidental unblinding, including subjects ability to continue in the study, and implements corrective action, if needed, with support. Can verbalize the emergency unblinding procedure in the protocol.

Intermediate Monitor: Verifies integrity of blind, adherence to stratification and randomization process. Identifies reporting procedures for accidental unblinding, including subjects ability to continue in the study, and implements corrective action, if needed, with limited support. Can verbalize the emergency unblinding procedure in the protocol.

Senior Monitor: Verifies integrity of blind, adherence to stratification and randomization process. Identifies reporting procedures for accidental unblinding, including subjects ability to continue in the study, and implements corrective action, if needed. Can verbalize the emergency unblinding procedure in the protocol. Mentors junior CRAs in blinding, unblinding and randomization procedures.

Clinical Lead: Confirms CRA team verifies integrity of blind, adherence to stratification and randomization processes. Identifies reporting procedures for accidental unblinding, including subjects ability to continue in the study, and implements corrective action, if needed. Can verbalize the emergency unblinding procedure in the protocol. Mentors junior CRAs in blinding, unblinding and randomization procedures.

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Domain: Study and Site Management.

Competency: Assessment of PI Qualification and Resources.

Expectation: Assesses study protocol activities to verify trial records are accurate, complete and current. Confirms the PI or delegated staff member has performed and documented all activities. Throughout the trial, evaluates investigator and site staff for qualification and training, provides study-specific training and inspects facilities to confirm adequacy. Evaluates compliance with the protocol and GCP and investigator engagement and revises the risk mitigation plans as necessary based on performance. Verifies documentation of investigator oversight and delegation. Evaluates the PIs availability to meet to discuss study progress, understanding of the study protocol, status of all subjects, applicable regulations, and ICH-GCP and overall level of involvement in implementing compliance. Identifies and escalates issues and implements corrective action.

Entry-Level Monitor: Assesses study protocol activities to verify trial records are accurate, complete and current. Confirms the PI or delegated staff member has performed and documented all activities. Throughout the trial, evaluates investigator and site staff for qualification and training, provides study-specific training and inspects facilities to confirm adequacy. Evaluates compliance with the protocol and GCP and investigator engagement and revises, with guidance, risk mitigation plans as necessary based on performance. Verifies documentation of investigator oversight and delegation. Evaluates the PIs availability to meet to discuss study progress, understanding of the study protocol, status of all subjects, applicable regulations, and ICH-GCP and overall level of involvement in implementing compliance. Identifies and escalates issues and implements corrective action.

Intermediate Monitor: Assesses study protocol activities to verify trial records are accurate, complete and current. Confirms the PI or delegated staff member has performed and documented all activities. Throughout the trial, evaluates investigator and site staff for qualification and training, provides study-specific training and inspects facilities to confirm adequacy. Evaluates compliance with the protocol and GCP and investigator engagement and revises, with minimal guidance, risk mitigation plans as necessary based on performance. Verifies documentation of investigator oversight and delegation. Evaluates the PIs availability to meet to discuss study progress, understanding of the study protocol, status of all subjects, applicable regulations, and ICH-GCP and overall level of involvement in implementing compliance. Identifies and escalates issues and implements corrective action. Performs root cause analysis and utilizes available resources to implement corrective and preventive actions.

Senior Monitor: Assesses study protocol activities to verify trial records are accurate, complete and current. Confirms the PI or delegated staff member has performed and documented all activities. Throughout the trial, evaluates investigator and site staff for qualification and training, provides study-specific training and inspects facilities to confirm adequacy. Evaluates compliance with the protocol and GCP and investigator engagement and revises the risk mitigation plans as necessary based on performance. Verifies documentation of investigator oversight and delegation. Evaluates the PIs availability to meet to discuss study progress, understanding of the study protocol, status of all subjects, applicable regulations, and ICH-GCP and overall level of involvement in implementing compliance. Identifies and escalates issues and implements corrective action. Performs root cause analysis, evaluates process gaps and uses available resources to develop and implement corrective and preventive actions. Serves as a resource and mentor to team members.

Clinical Lead: Assesses study protocol activities to verify trial records are accurate, complete and current. Confirms the PI or delegated staff member has performed and documented all activities. Throughout the trial, evaluates investigator and site staff for qualification and training, provides study specific training and inspects facilities to confirm adequacy. Evaluates compliance with the protocol and GCP and investigator engagement and revises the risk mitigation plans as necessary based on performance. Verifies documentation of investigator oversight and delegation. Evaluates the PIs availability to meet to discuss study progress, understanding of the study protocol, status of all subjects, applicable regulations, and ICH-GCP and overall level of involvement in implementing compliance. Identifies and escalates issues and implements corrective action. Performs root cause analysis, evaluates process gaps and uses available resources to develop and implement corrective and preventive actions. Serves as a resource and mentor to team members. Instructs and guides team through problem solving and mobilizes team to intended goals and solutions. Assesses applicability of issues and solutions across study. Engages in risk management with internal and external stakeholders.

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Domain: Data Management and Informatics.

Competency: Critical Data & Processes.

Expectation: Performs data review utilizing system of record to identify and mitigate potential issues and risks. Has an awareness of the interrelatedness of study systems and analyzes data trends to direct future monitoring actions. Communicates with centralized monitoring team members. References risk assessment documentation to anticipate and mitigate potential issues.

Entry-Level Monitor: Performs data review utilizing system of record to identify and mitigate potential issues and risks. With support, begins to develop an awareness of the interrelatedness of study systems and analyzes data trends to direct future monitoring actions. Communicates with centralized monitoring team members. References risk assessment documentation to anticipate and mitigate potential issues. Identifies and escalates issues and implements corrective action preventive plan.

Intermediate Monitor: Performs data review utilizing system of record to identify and mitigate potential issues and risks. Analyzes data trends and site performance metrics. Communicates with centralized monitoring team members. References risk assessment documentation to anticipate and mitigate potential issues.Identifies and escalates issues and implements corrective action preventive plan. Performs root cause analysis and utilizes available resources to implement corrective and preventive actions.

Senior Monitor: Performs data review utilizing system of record to identify and mitigate potential issues and risks. Has an awareness of the interrelatedness of study systems and analyzes data trends to direct future monitoring actions. Communicates with centralized monitoring team members. References risk assessment documentation to anticipate and mitigate potential issues.Identifies and escalates issues and implements corrective action preventive plan. Performs root cause analysis and utilizes available resources to implement corrective and preventive actions. Serves as mentor and resource to team members.

Clinical Lead: Performs data review utilizing system of record to identify and mitigate potential issues and risks. Knows the interrelatedness of study systems and analyzes data trends to direct future monitoring actions. Executes communication plan with centralized monitoring team members and/or onsite monitoring team members. References risk assessment documentation to anticipate and mitigate potential issues.Identifies and escalates issues and implements corrective action preventive plan. Performs root cause analysis and utilizes available resources to implement corrective and preventive actions. Serves as mentor and resource to team members. Analyzes data trends across sites and project and recommends, develops, implements and assesses applicability of risk-mitigation plans. Engages in risk management with internal and external stakeholders.

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Domain: Data Management and Informatics.

Competency: Query Issuance and Resolution.

Expectation: Writes clear, concise and directed queries that comply with ICH-GCP. Works with site staff to facilitate effective query resolution processes and timeline compliance.

Entry-Level Monitor: Writes clear, concise and directed queries that comply with ICH-GCP. Works with site staff to facilitate effective query resolution processes and timeline compliance. Maintains effective communication with site staff to resolve queries and escalate issues.

Intermediate Monitor: Writes clear, concise and directed queries that comply with ICH-GCP. Works with site staff to facilitate effective query resolution processes and timeline compliance. Maintains effective communication with site staff to resolve queries and escalate issues. Provides detailed query reports/status to site staff.

Senior Monitor: Writes clear, concise and directed queries that comply with ICH-GCP. Works with site staff to facilitate effective query resolution processes and timeline compliance. Maintains effective communication with site staff to resolve queries and escalate issues. Provides detailed query reports/status to site staff. Understands, escalates and resolves issues regarding study progress and data delivery per timelines. Performs root cause analysis of data quality, evaluates process gaps and uses available resources to develop and implement corrective and preventive actions.

Clinical Lead: Writes clear, concise and directed queries that comply with ICH-GCP. Works with site staff to facilitate effective query resolution processes and timeline compliance. Maintains effective communication with site staff to resolve queries and escalate issues. Provides detailed query reports/status to site staff. Understands, escalates and resolves issues regarding study progress and data delivery per timelines. Performs root cause analysis of data quality, evaluates process gaps and uses available resources to develop and implement corrective and preventive actions. Creates and provides detailed query metrics to project stakeholders. Evaluates query trends and solutions to mitigate risk.

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Domain: Data Management and Informatics.

Competency: Clinical Trial Systems of Record.

Expectation: Demonstrates competency with clinical trial systems of record and reports on site and project metrics accurately and on time.

Entry-Level Monitor: Demonstrates competency with clinical trial systems of record and reports on site and project metrics accurately and on time. Produces and uses site and project reports to expedite processes and task completion.

Intermediate Monitor: Demonstrates competency with clinical trial systems of record and reports on site and project metrics accurately and on time. Produces and uses site and project reports to expedite processes and task completion. Serves as resource and mentor to team members to answer questions about system best practices.

Senior Monitor: Demonstrates competency with clinical trial systems of record and reports on site and project metrics accurately and on time. Produces and uses site and project reports to expedite processes and task completion. Serves as resource and mentor to team members to answer questions about system best practices.

Clinical Lead: Demonstrates competency with clinical trial systems of record and reports on site and project metrics accurately and on time. Produces and uses site and project reports to expedite processes and task completion. Serves as resource and mentor to team members to answer questions about system best practices. Consults with system administrators through project lifecycle to manage system access of clinical team and sites. Mitigates data capture and reporting risks.

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Domain: Data Management and Informatics.

Competency: Compliance with Electronic Record Requirements and Regulations.

Expectation: Completes and documents regulatory compliance assessment.

Entry-Level Monitor: Confirms that site systems used for study conduct are assessed for study use and compliant with ICH GCP. Verifies system access is well controlled. Identifies and escalates issues and implements corrective action.

Intermediate Monitor: Confirms that site systems used for study conduct are assessed for study use and compliant with ICH GCP. Verifies system access is well controlled. Identifies and escalates issues and implements corrective action. Performs root cause analysis, evaluates process gaps and uses available resources to develop and implement corrective and preventive actions.

Senior Monitor: Confirms that site systems used for study conduct are assessed for study use and compliant with ICH GCP. Verifies system access is well controlled. Identifies and escalates issues and implements corrective action. Performs root cause analysis, evaluates process gaps and uses available resources to develop and implement corrective and preventive actions.

Clinical Lead: Confirms that site systems used for study conduct are assessed for study use and compliant with ICH GCP. Verifies system access is well controlled. Identifies and escalates issues and implements corrective action. Performs root cause analysis, evaluates process gaps and uses available resources to develop and implement corrective and preventive actions. Assesses applicability of solutions across study.

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Domain: Leadership and Profession alism.

Competency: Personal Work Product Accountability.

Expectation: Submits quality deliverables on time, and participates in and contributes to team activities. When not able to meet timelines, informs appropriate manager and team members in advance of deadline so that remediation activities can be identified and implemented.

Entry-Level Monitor: Submits quality deliverables on time, and participates in and contributes to team activities. Assimilates to shifting requests and priorities. When not able to meet timelines, informs appropriate manager and team members in advance of deadline so that remediation activities can be identified and implemented.

Intermediate Monitor: Submits quality deliverables on time, and participates in and contributes to team activities. Assimilates to shifting requests and priorities. When not able to meet timelines, informs appropriate manager and team members in advance of deadline so that remediation activities can be identified and implemented.

Senior Monitor: Submits quality deliverables on time, and participates in and contributes to team activities. Assimilates to shifting requests and priorities. When not able to meet timelines, informs appropriate manager and team members in advance of deadline so that remediation activities can be identified and implemented. Identifies and initiates improvement measures to confirm internal processes are efficient.

Clinical Lead: Submits quality deliverables on time, and participates in and contributes to team activities. Assimilates to shifting requests and priorities. When not able to meet timelines, informs appropriate manager and team members in advance of deadline so that remediation activities can be identified and implemented. Identifies and initiates improvement measures to confirm internal processes are efficient. Accountable for project and team performance. Provides team oversight to confirm project expectations and deadlines are met. Develops solutions to improve performance.

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Domain: Leadership and Profession alism.

Competency: Cultural Awareness and Sensitivity.

Expectation: Demonstrates respect for cultural diversity and conventions. Anticipates areas of cultural sensitivity and develops proactive means to address them.

Entry-Level Monitor: Promotes respect for cultural diversity and conventions with all individuals. With support, identifies areas of cultural sensitivity and develops proactive means to address them. Demonstrates ability to successfully establish and maintain culturally sensitive working relationships.

Intermediate Monitor: Promotes respect for cultural diversity and conventions with all individuals. With minimal support, anticipates areas of cultural sensitivity and develops proactive means to address them. Demonstrates ability to successfully establish and maintain culturally sensitive working relationships.

Senior Monitor: Promotes respect for cultural diversity and conventions with all individuals. Anticipates areas of cultural sensitivity and develops proactive means to address them. Demonstrates ability to successfully establish and maintain culturally sensitive working relationships. Acts as role model demonstrating respect for the variety of thought while encouraging alignment with the strategic direction.

Clinical Lead: Promotes respect for cultural diversity and conventions with all individuals. Anticipates areas of cultural sensitivity and coaches/trains project team on proactive means to address them. Demonstrates ability to successfully establish and maintain culturally sensitive working relationships. Models respect for variety of thought while encouraging alignment with the strategic direction. Confirms team members comply with professional standards.

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Domain: Leadership and Profession alism.

Competency: Professional Behavior.

Expectation: Demonstrates and projects professional demeanor and communications consistent with organizational policies and practices.

Entry-Level Monitor: Demonstrates and projects professional demeanor and communications consistent with organizational policies and practices. Behaves in ways that demonstrate and foster personal initiative, critical thinking and trustworthiness. Remains accountable to and positively engaged with others. Demonstrates commitment to customer service.

Intermediate Monitor: Demonstrates and projects professional demeanor and communications consistent with organizational policies and practices. Behaves in ways that demonstrate and foster personal initiative, critical thinking and trustworthiness. Remains accountable to and positively engaged with others. Demonstrates commitment to customer service.

Senior Monitor: Demonstrates and projects professional demeanor and communications consistent with organizational policies and practices. Behaves in ways that demonstrate and foster personal initiative, critical thinking and trustworthiness. Remains accountable to and positively engaged with others. Demonstrates commitment to customer service.

Clinical Lead: Demonstrates and projects professional demeanor and communications consistent with organizational policies and practices. Behaves in ways that demonstrate and foster personal initiative, critical thinking and trustworthiness. Remains accountable to and positively engaged with others. Demonstrates commitment to customer service. Confirms team members comply with professional standards.

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Domain: Communication and Teamwork.

Competency: Relationship and Communication with Clinical Study Team Members and Investigative Site Staff.

Expectation: Communicates to effectively resolve compliance issues. Provides clear and technically accurate information and instructions, both orally and in writing. Maintains timely communication. Engages in effective discussions. Demonstrates attentive and active listening. Abides by communication plan and pathway.

Entry-Level Monitor: Communicates to effectively resolve compliance issues. Provides clear and technically accurate information and instructions, both orally and in writing. Maintains timely communication. Engages in effective discussions. Demonstrates attentive and active listening. Abides by communication plan and pathway.

Intermediate Monitor: Communicates to effectively resolve compliance issues. Provides clear and technically accurate information and instructions, both orally and in writing. Maintains timely communication. Engages in effective discussions. Demonstrates attentive and active listening. Abides by communication plan and pathway.

Senior Monitor: Communicates to effectively resolve compliance issues. Provides clear and technically accurate information and instructions, both orally and in writing. Maintains timely communication. Engages in effective discussions. Demonstrates attentive and active listening. Abides by communication plan and pathway.

Clinical Lead: Communicates to effectively resolve compliance issues. Provides clear and technically accurate information and instructions, both orally and in writing. Maintains timely communication. Engages in effective discussions. Demonstrates attentive and active listening. Abides by communication plan and pathway. Confirms team members comply with professional communication standards.

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