Spec 1, Clinical Operations - Onsite (Urgent Need)
Behavioral Health Market Context
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Job Description
issues, status of open device issues/queries, etc.)
• Develop and execute device processes associated with clinical trials.
• Ensure compliance with regulations and manage the lifecycle of devices, while closely partnering with other internal key stakeholders ( e.g., clinical study teams, Manufacturing Operations, Finance, Supply Chain, Quality, and Compliance groups) to develop and lead the execution of the device process, and ensuring continuous process improvement of efficiency and accuracy of processes and procedures.
• Verify inventory and process device shipment to clinical sites within our shipping timeframe to Customer Service, Trade Compliance, and other relevant stakeholders.
• Confirm receipt of product with the clinical site and obtain copies of signed and dated packing slips. Monitor device inventory by coordinating with Supply Chain and Clinical Specialists
• Develop timeline assessments (e.g., transition to new device system, system enhancements to meet supply and demand, etc) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines.
• Ensure documentation are archived appropriately within record retention facility (e.g., Iron Mountain, clinicaltrial.gov)
• Track, manage, and coordinate clinical study invoice processing to ensure timely review, approval, and payment.
• Generate reports on outstanding invoice payments for clinical study team review
• Review and ensure accuracy and completeness of clinical study files, enter into computerized tracking system, and file/scan for archive, for multiple clinical research trials
• Maintains current and active licensure and certification(s) to administer First Aid, BLS and CPR for emergent needs in healthy volunteer clinical research studies
• Support clinical research laboratory operations as needed
• Other incidental duties as assigned
Required
• At least 2 years in a clinical role such as Emergency Medical Technician or Medical Assistant
• Current CPR and First Aid certification from an accredited provider
Preferred experience/qualifications:
• Associate's/Bachelor’s degree in a related field
• >1-2 years of patient-facing experience in a clinical research, healthcare, or related medical setting.
• Develop and execute device processes associated with clinical trials.
• Ensure compliance with regulations and manage the lifecycle of devices, while closely partnering with other internal key stakeholders ( e.g., clinical study teams, Manufacturing Operations, Finance, Supply Chain, Quality, and Compliance groups) to develop and lead the execution of the device process, and ensuring continuous process improvement of efficiency and accuracy of processes and procedures.
• Verify inventory and process device shipment to clinical sites within our shipping timeframe to Customer Service, Trade Compliance, and other relevant stakeholders.
• Confirm receipt of product with the clinical site and obtain copies of signed and dated packing slips. Monitor device inventory by coordinating with Supply Chain and Clinical Specialists
• Develop timeline assessments (e.g., transition to new device system, system enhancements to meet supply and demand, etc) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines.
• Ensure documentation are archived appropriately within record retention facility (e.g., Iron Mountain, clinicaltrial.gov)
• Track, manage, and coordinate clinical study invoice processing to ensure timely review, approval, and payment.
• Generate reports on outstanding invoice payments for clinical study team review
• Review and ensure accuracy and completeness of clinical study files, enter into computerized tracking system, and file/scan for archive, for multiple clinical research trials
• Maintains current and active licensure and certification(s) to administer First Aid, BLS and CPR for emergent needs in healthy volunteer clinical research studies
• Support clinical research laboratory operations as needed
• Other incidental duties as assigned
Required
• At least 2 years in a clinical role such as Emergency Medical Technician or Medical Assistant
• Current CPR and First Aid certification from an accredited provider
Preferred experience/qualifications:
• Associate's/Bachelor’s degree in a related field
• >1-2 years of patient-facing experience in a clinical research, healthcare, or related medical setting.
Qualifications
- •At least 2 years in a clinical role such as Emergency Medical Technician or Medical Assistant
- •Current CPR and First Aid certification from an accredited provider
Benefits
Responsibilities
- •Hours: Mon-Fri, 8am - 5pm
- •Identify, develop, recommend, and implement, moderately complex process development and process improvement solutions to optimize global trial workflow timelines, (e.g., device return aging issues, status of open device issues/queries, etc.)
- •Develop and execute device processes associated with clinical trials
- •Ensure compliance with regulations and manage the lifecycle of devices, while closely partnering with other internal key stakeholders ( e.g., clinical study teams, Manufacturing Operations, Finance, Supply Chain, Quality, and Compliance groups) to develop and lead the execution of the device process, and ensuring continuous process improvement of efficiency and accuracy of processes and procedures
- •Verify inventory and process device shipment to clinical sites within our shipping timeframe to Customer Service, Trade Compliance, and other relevant stakeholders
- •Confirm receipt of product with the clinical site and obtain copies of signed and dated packing slips
- •Monitor device inventory by coordinating with Supply Chain and Clinical Specialists
- •Develop timeline assessments (e.g., transition to new device system, system enhancements to meet supply and demand, etc) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines
- •Ensure documentation are archived appropriately within record retention facility (e.g., Iron Mountain, clinicaltrial.gov)
- •Track, manage, and coordinate clinical study invoice processing to ensure timely review, approval, and payment
- •Generate reports on outstanding invoice payments for clinical study team review
- •Review and ensure accuracy and completeness of clinical study files, enter into computerized tracking system, and file/scan for archive, for multiple clinical research trials
- •Maintains current and active licensure and certification(s) to administer First Aid, BLS and CPR for emergent needs in healthy volunteer clinical research studies
- •Support clinical research laboratory operations as needed
- •Other incidental duties as assigned
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