BioFire Diagnostics
Clinical Research Scientist
BioFire Diagnostics, Durham, North Carolina, United States, 27703
Clinical Research Scientist
The Clinical Research Scientist leads the execution of the clinical studies that make up the company's clinical evidence generation program. In this role, you will execute clinical studies and/or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures. The Clinical Research Scientist collaborates closely with cross-functional teams, including Medical Scientists, Biostatistics & Data Management, Medical Writers, and Marketing to generate impactful clinical evidence that supports the company's strategy. This role is crucial in maintaining our commitment to scientific excellence and patient-centric approaches within the competitive global healthcare landscape. This position can also be located in Durham, North Carolina. Primary Duties
Contributes to the development and leads the implementation of study strategy with internal stakeholders. Contributes to the development of the study synopsis. Leads the development of study plan for non-registrational studies. Leads the development of BIR/CIR study protocols for non-registrational studies. Reviews IIR study protocols. Leads site selection activities. Serves as Global Medical Affairs point of contact with external resources and contacts at various management levels concerning clinical operations or scheduling of specific phases of clinical studies. Functionally responsible for all clinical monitoring activities throughout study. Manages clinical study agreements. Manages the coordination of logistics and training needed to execute studies. Outline and communicate safety issues and planned mitigations in collaboration with internal stakeholders. Assures clear external/internal team communication, process documentation, and compliance with BMX and departmental processes along with GCP. Contributes to the assessment of processes and establishing plans for improvements. Manages IIR study execution/follow-up with little to no supervision. Defines and manages study budget. Accountable for the delivery of documentation to meet study milestones. Coordinates the creation of the study database/CRF and reviews data/analysis with cross-functional teams. Contributes to or leads the development of study abstract and/or poster in collaboration with internal stakeholders. Contributes to peer-reviewed journal publication of study results in collaboration with internal stakeholders. All other duties as assigned. Experience
Bachelor's degree in a life science field (biology, chemistry, medical/clinical laboratory technologist etc.) required. Master's or PhD preferred. 5+ years of experience conducting in vitro diagnostics and/or medical device clinical research with responsibilities for managing all major aspects of strategic planning, organization, implementation and delivery of clinical studies. Experience with the management of timelines, deliverables, and milestones. Experience with budget oversight, risk mitigation, and clinical data review. Understands the US and European Medical Testing environments and relevant professional societies and guidelines (e.g. FDA, CE-Mark IVD Directives, CAP, CLIA, WHO, IASLC, ASCCP, etc.) Proven track record of writing clinical study plans and study protocols. Knowledge, Skills & Abilities
Strong computer skills including word processing and use of spreadsheets. Skills with database and project management software desirable. Demonstrate ability to work collaboratively with various stakeholders in a highly matrixed global environment. Good communication skills.
The Clinical Research Scientist leads the execution of the clinical studies that make up the company's clinical evidence generation program. In this role, you will execute clinical studies and/or programs worldwide in accordance with strategy, project plans, approved budget and resource allocations following applicable regulatory and standard operating procedures. The Clinical Research Scientist collaborates closely with cross-functional teams, including Medical Scientists, Biostatistics & Data Management, Medical Writers, and Marketing to generate impactful clinical evidence that supports the company's strategy. This role is crucial in maintaining our commitment to scientific excellence and patient-centric approaches within the competitive global healthcare landscape. This position can also be located in Durham, North Carolina. Primary Duties
Contributes to the development and leads the implementation of study strategy with internal stakeholders. Contributes to the development of the study synopsis. Leads the development of study plan for non-registrational studies. Leads the development of BIR/CIR study protocols for non-registrational studies. Reviews IIR study protocols. Leads site selection activities. Serves as Global Medical Affairs point of contact with external resources and contacts at various management levels concerning clinical operations or scheduling of specific phases of clinical studies. Functionally responsible for all clinical monitoring activities throughout study. Manages clinical study agreements. Manages the coordination of logistics and training needed to execute studies. Outline and communicate safety issues and planned mitigations in collaboration with internal stakeholders. Assures clear external/internal team communication, process documentation, and compliance with BMX and departmental processes along with GCP. Contributes to the assessment of processes and establishing plans for improvements. Manages IIR study execution/follow-up with little to no supervision. Defines and manages study budget. Accountable for the delivery of documentation to meet study milestones. Coordinates the creation of the study database/CRF and reviews data/analysis with cross-functional teams. Contributes to or leads the development of study abstract and/or poster in collaboration with internal stakeholders. Contributes to peer-reviewed journal publication of study results in collaboration with internal stakeholders. All other duties as assigned. Experience
Bachelor's degree in a life science field (biology, chemistry, medical/clinical laboratory technologist etc.) required. Master's or PhD preferred. 5+ years of experience conducting in vitro diagnostics and/or medical device clinical research with responsibilities for managing all major aspects of strategic planning, organization, implementation and delivery of clinical studies. Experience with the management of timelines, deliverables, and milestones. Experience with budget oversight, risk mitigation, and clinical data review. Understands the US and European Medical Testing environments and relevant professional societies and guidelines (e.g. FDA, CE-Mark IVD Directives, CAP, CLIA, WHO, IASLC, ASCCP, etc.) Proven track record of writing clinical study plans and study protocols. Knowledge, Skills & Abilities
Strong computer skills including word processing and use of spreadsheets. Skills with database and project management software desirable. Demonstrate ability to work collaboratively with various stakeholders in a highly matrixed global environment. Good communication skills.