Senior/Lead CRA
60K–80K a year
Behavioral Health Market Context
Apply Nowvia Learn4Good
Job Description
linical Practice (GCP), company SOPs, and applicable regulatory requirements. In addition to CRO oversight responsibilities, this role will support clinical data review, Trial Master File (TMF) review, and monitoring visit report review during non-travel or lower monitoring periods to ensure studies are conducted with high quality, regulatory compliance and strong site engagement.
This role is ideal for a monitoring-focused CRA who is passionate about site oversight, ensuring high-quality study conduct
and monitoring excellence
, while partnering closely with external CROs and Investigative sites and who is seeking a clear path toward advancement into Project Manager, or Clinical Trial Manager
.
Role & Responsibilities
• Serves as the Sponsor representative responsible for oversight of CRO-assigned CRAs and all related site monitoring activities
• Reviews and assesses the quality, consistency, and timeliness of CRO monitoring activities across assigned studies
• Ensures monitoring plans are executed appropriately and that site oversight activities align with protocol, GCP, and sponsor expectations.
• Reviews CRO monitoring outputs and escalates significant quality, compliance, or performance concerns as needed
• Partners with CRAs from the CRO to ensure robust ongoing data monitoring strategies are carried out effectively to ensure delivery of high-quality data appropriately
• Ensures Protocol Deviations, key site findings, risks (including site performance concerns, subject safety issues, data quality risks, etc.) and follow-up items are clearly captured and resolved in a timely manner
• Participates in routine meetings with the CRO teams to review site performance, enrollment, data quality, and study risks
• Supports vendor and CRO performance management by identifying trends and recommending process improvements
• May need to review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites
• Reviews CRO-generated monitoring visit reports for completeness, quality, consistency, adequacy of issue documentation, and appropriateness of action plans
• Provides feedback to CRO CRAs and study teams to improve monitoring documentation and oversight quality.
• Maintain Sponsor-level visibility into site performance and monitoring quality as well as identify sites requiring additional support, escalation, or corrective action
• Participates in co-monitoring visits, oversight visits, or targeted site visits as needed
• Supports inspection readiness and audit preparedness activities related to site conduct and monitoring oversight
• Develops and provides clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings
• Provides support to the Study Lead for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc.
• Provides study-level insight into site performance, monitoring effectiveness, and operational risks
• Contributes to study team discussions related to quality, enrollment, compliance, and risk mitigation
• Supports the study lead in reviewing and approving of the essential document packages to enable timely site activations
• Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete
• Assesses and supports investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary Conducts routine review of the Trial Master File (TMF) to ensue documents are complete, current, and inspection ready.
• Identify missing, outdated, or incorrectly filed documents and coordinate follow-up with CROs and internal study teams
• Supports TMF quality oversight to ensure compliance with Sponsor and regulatory expectations
• Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs Performs targeted clinical data review to identify data discrepancies, unusual trends, missing data, protocol-related inconsistencies and potential site quality concerns
• Collaborates with data management, medical monitoring, and clinical operations teams to support timely query resolution and data cleaning
• Uses data review findings to proactively identify sites that may require additional CRO monitoring attention or Sponsor oversight
• Responsible for supporting functional…
This role is ideal for a monitoring-focused CRA who is passionate about site oversight, ensuring high-quality study conduct
and monitoring excellence
, while partnering closely with external CROs and Investigative sites and who is seeking a clear path toward advancement into Project Manager, or Clinical Trial Manager
.
Role & Responsibilities
• Serves as the Sponsor representative responsible for oversight of CRO-assigned CRAs and all related site monitoring activities
• Reviews and assesses the quality, consistency, and timeliness of CRO monitoring activities across assigned studies
• Ensures monitoring plans are executed appropriately and that site oversight activities align with protocol, GCP, and sponsor expectations.
• Reviews CRO monitoring outputs and escalates significant quality, compliance, or performance concerns as needed
• Partners with CRAs from the CRO to ensure robust ongoing data monitoring strategies are carried out effectively to ensure delivery of high-quality data appropriately
• Ensures Protocol Deviations, key site findings, risks (including site performance concerns, subject safety issues, data quality risks, etc.) and follow-up items are clearly captured and resolved in a timely manner
• Participates in routine meetings with the CRO teams to review site performance, enrollment, data quality, and study risks
• Supports vendor and CRO performance management by identifying trends and recommending process improvements
• May need to review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites
• Reviews CRO-generated monitoring visit reports for completeness, quality, consistency, adequacy of issue documentation, and appropriateness of action plans
• Provides feedback to CRO CRAs and study teams to improve monitoring documentation and oversight quality.
• Maintain Sponsor-level visibility into site performance and monitoring quality as well as identify sites requiring additional support, escalation, or corrective action
• Participates in co-monitoring visits, oversight visits, or targeted site visits as needed
• Supports inspection readiness and audit preparedness activities related to site conduct and monitoring oversight
• Develops and provides clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings
• Provides support to the Study Lead for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc.
• Provides study-level insight into site performance, monitoring effectiveness, and operational risks
• Contributes to study team discussions related to quality, enrollment, compliance, and risk mitigation
• Supports the study lead in reviewing and approving of the essential document packages to enable timely site activations
• Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete
• Assesses and supports investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary Conducts routine review of the Trial Master File (TMF) to ensue documents are complete, current, and inspection ready.
• Identify missing, outdated, or incorrectly filed documents and coordinate follow-up with CROs and internal study teams
• Supports TMF quality oversight to ensure compliance with Sponsor and regulatory expectations
• Oversee the execution of clinical trial activities in accordance with Good Clinical Practices. Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs Performs targeted clinical data review to identify data discrepancies, unusual trends, missing data, protocol-related inconsistencies and potential site quality concerns
• Collaborates with data management, medical monitoring, and clinical operations teams to support timely query resolution and data cleaning
• Uses data review findings to proactively identify sites that may require additional CRO monitoring attention or Sponsor oversight
• Responsible for supporting functional…
Qualifications
Benefits
Responsibilities
- •The Clinical Research Associate (CRA) is responsible for supporting the successful execution of clinical trials through oversight of CRO monitoring activities
- •, site quality management, and clinical data review
- •This role will collaborate with functional team members, oversee the CRO’s assigned monitors and monitor deliverables ensuring studies are conducted in compliance with the protocol,
- •Good Clinical Practice (GCP), company SOPs, and applicable regulatory requirements
- •In addition to CRO oversight responsibilities, this role will support clinical data review, Trial Master File (TMF) review, and monitoring visit report review during non-travel or lower monitoring periods to ensure studies are conducted with high quality, regulatory compliance and strong site engagement
- •This role is ideal for a monitoring-focused CRA who is passionate about site oversight, ensuring high-quality study conduct
- •and monitoring excellence
- •, while partnering closely with external CROs and Investigative sites and who is seeking a clear path toward advancement into Project Manager, or Clinical Trial Manager
- •Serves as the Sponsor representative responsible for oversight of CRO-assigned CRAs and all related site monitoring activities
- •Reviews and assesses the quality, consistency, and timeliness of CRO monitoring activities across assigned studies
- •Ensures monitoring plans are executed appropriately and that site oversight activities align with protocol, GCP, and sponsor expectations
- •Reviews CRO monitoring outputs and escalates significant quality, compliance, or performance concerns as needed
- •Partners with CRAs from the CRO to ensure robust ongoing data monitoring strategies are carried out effectively to ensure delivery of high-quality data appropriately
- •Ensures Protocol Deviations, key site findings, risks (including site performance concerns, subject safety issues, data quality risks, etc.) and follow-up items are clearly captured and resolved in a timely manner
- •Participates in routine meetings with the CRO teams to review site performance, enrollment, data quality, and study risks
- •Supports vendor and CRO performance management by identifying trends and recommending process improvements
- •May need to review/approve/track vendor invoices and manage accruals and payment process for all assigned clinical trial vendors including investigational sites
- •Reviews CRO-generated monitoring visit reports for completeness, quality, consistency, adequacy of issue documentation, and appropriateness of action plans
- •Provides feedback to CRO CRAs and study teams to improve monitoring documentation and oversight quality
- •Maintain Sponsor-level visibility into site performance and monitoring quality as well as identify sites requiring additional support, escalation, or corrective action
- •Participates in co-monitoring visits, oversight visits, or targeted site visits as needed
- •Supports inspection readiness and audit preparedness activities related to site conduct and monitoring oversight
- •Develops and provides clear, complete documentation of study-specific meetings, action items and action item closure for assigned study meetings
- •Provides support to the Study Lead for the development and management of clinical trial documents including (but not limited to), consent documents, site welcome packets, study binders, etc
- •Provides study-level insight into site performance, monitoring effectiveness, and operational risks
- •Contributes to study team discussions related to quality, enrollment, compliance, and risk mitigation
- •Supports the study lead in reviewing and approving of the essential document packages to enable timely site activations
- •Conducts and tracks Monitoring Report Review to ensure compliance with procedures across duration of study and documentation is complete
- •Assesses and supports investigator performance guidance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary Conducts routine review of the Trial Master File (TMF) to ensue documents are complete, current, and inspection ready
- •Identify missing, outdated, or incorrectly filed documents and coordinate follow-up with CROs and internal study teams
- •Supports TMF quality oversight to ensure compliance with Sponsor and regulatory expectations
- •Oversee the execution of clinical trial activities in accordance with Good Clinical Practices
- •Ensures compliance of clinical trials with national regulatory requirements and co-monitoring the assigned clinical trial following company SOPs Performs targeted clinical data review to identify data discrepancies, unusual trends, missing data, protocol-related inconsistencies and potential site quality concerns
- •Collaborates with data management, medical monitoring, and clinical operations teams to support timely query resolution and data cleaning
- •Uses data review findings to proactively identify sites that may require additional CRO monitoring attention or Sponsor oversight
- •Responsible for supporting functional…
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