Clinical Trial Manager - East Coast HeartFlowClinical Trial Manager - East CoastBoston, MARemote$95,000–$130,000 / yearHeartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMapAnalysis), assess coronary blood flow (FFRCT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis). The flagship product-an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFRCT Analysis-provides a color-coded, 3D model of a patient's coronary arteries indicating the impact blockages have on blood flow to the heart.
Senior Clinical Study Manager Integrated Resources, IncSenior Clinical Study ManagerCambridge, MassachusettsFull timeProvides Clinical Operations input to other important study activities, including but not limited to: site identification and selection, enrollment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of Trial Master File, development of monitoring plans, development of IxRS systems, development of EDC / Case Report Forms, review of data during the study, data cleaning and database lock, writing the Clinical Study Report. In collaboration with Study Execution Team (Takeda functions, Strategic Partners, and vendors), identify risks to study and develop risk mitigation plans, including communication and collaboration with Clinical Program Manager and Associate Director, Clinical Operations to escalate risks and ensure rigorous risk mitigation planning.
Drug Safety Assistant Integrated Resources, IncDrug Safety AssistantSomerville, MassachusettsContractorA Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. • Maintain local documentation as required by legislation (including archiving/tracking/retrieval) – lifting of boxes.
Administrative Assistant Integrated Resources, IncAdministrative AssistantLexington, MassachusettsFull timeHas intermediate to advanced computer skills including: word processing, spreadsheet, presentation, desktop publishing, database and/or project management applications. A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.
Administrator Assistant Position Integrated Resources, IncAdministrator Assistant PositionLexington, MassachusettsContractorPerforms more complex administrative activities including managing projects, composing letters and reports, preparing/editing presentations, recommending or making purchase decisions, managing budget and payroll, and developing newsletters. Has intermediate to advanced computer skills including: word processing, spreadsheet, presentation, desktop publishing, database and/or project management applications.
Sr. Administrative Assistant Integrated Resources, IncSr. Administrative AssistantLexington, MassachusettsFull timeHas intermediate to advanced computer skills including: word processing, spreadsheet, presentation, desktop publishing, database and/or project management applications. A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.
Senior Administrative Assistant Integrated Resources, IncSenior Administrative AssistantLexington, MassachusettsContractormanaging projects, composing letters and reports, preparing/editing presentations, recommending or making purchase decisions, managing budget and payroll, and developing newsletters. Has intermediate to advanced computer skills including: word processing, spreadsheet, presentation, desktop publishing, database and/or project management applications.
Medical Writer Integrated Resources, IncMedical WriterMassachusettsContractorPosition Title: Medical Writing Specialist Division: Strategic Medical Affairs Reports To: Medical Safety Project Manager Job Function Summary The Medical Writer Specialist is responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the DePuy Synthes Strategic Medical Affairs Team for a wide range of audiences. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.
Clinical Program Scientist Integrated Resources, IncClinical Program ScientistLexington, MassachusettsContractorLeads cross functional teams and is responsible for the oversight and management of study timelines as well as the financial management of a study. Ability to manage and communicate effectively with research vendors including reviewing requests for proposals, analyzing scope of work, and responding to inquiries and complaints.
Sr. Clinical Study Manager Integrated Resources, IncSr. Clinical Study ManagerCambridge, MassachusettsFull timeProvides Clinical Operations input to other important study activities, including but not limited to: site identification and selection, enrollment models, clinical supply planning and drug supply, organization of investigator and vendor meetings, development of informed consents forms, planning and management of Trial Master File, development of monitoring plans, development of IxRS systems, development of EDC / Case Report Forms, review of data during the study, data cleaning and database lock, writing the Clinical Study Report. In collaboration with Study Execution Team (functions, Strategic Partners, and vendors), identify risks to study and suggest risk mitigation plans, with oversight of Clinical Program Manager and Associate Director, Clinical Operations to escalate risks and ensure rigorous risk mitigation planning.
Director of Clinical Quality Integrated Resources, IncDirector of Clinical QualityCambridge, MassachusettsContractorJob Description: Job Title: Director, Vaccines Clinical Compound Support Quality Assurance OBJECTIVES: Plays a leadership role in ensuring that investigator, vendor, facility and system audits are conducted, for communicating any critical compliance risks noted from these activities to senior management, and ensuring that corrective actions are implemented. Collaborates with the R&D QA, and other global entities to provide a consistent quality approach, including: Develops and presents periodic reports for assigned project describing VBU compliance trends and identifying areas of potential risk to VBU senior management.
Clinical Site Relationship Manager Integrated Resources, IncClinical Site Relationship ManagerCambridge, MassachusettsContractorAssures ongoing site compliance with the protocols, informed consent process and documentation, as well as applicable FDA regulations and/or ICH GCP Guidelines and other local regulations critically reviews and analyzes site activities and study conduct through on-site and remote assessments/contacts. Responsible for development of study monitoring and management documentation and tools as delegated by the sponsor, including: Clinical Monitoring Plan, SIV slides, Regulatory Binder, Study Reference Guide, site tools, etc.
Lead Clinical Data Manager Integrated Resources, IncLead Clinical Data ManagerLexington, MassachusettsFull timeProvides status reports/updates, resolves disputes, and ensures timely acquisition of high quality deliverables from the CRO Provides Data Management expertise to the team in identifying opportunities for process and budgetary optimization Coordinates with Biostatistics and Statistical Programming to ensure appropriate design, documentation. • Takes action to ensure study and project priorities are maintained; ensures adjustment of plans as priorities evolve Contributes to regular budget forecasting and regular cost accrual processes and proactively communicates to the team budgetary impacts of decisions or processes implemented to achieve results Courage to challenge.
Executive Assistant II Integrated Resources, IncExecutive Assistant IILexington, MassachusettsFull timePerforms more complex administrative activities including managing projects, composing letters and reports, preparing/editing presentations, and recommending or making purchase decisions. A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.
Executive Assistant Integrated Resources, IncExecutive AssistantLexington, MassachusettsContractorPerforms more complex administrative activities including managing projects, composing letters and reports, preparing/editing presentations, and recommending or making purchase decisions. A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms.
Senior Lab Assistant - Environmental Monitoring Thermo Fisher ScientificSenior Lab Assistant - Environmental MonitoringBoston, MassachusettsWithin our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.
Sr. Medical Writer Integrated Resources, IncSr. Medical WriterMansfield, MassachusettsRemoteFull timeMust be highly proficient in the use of Microsoft Office suite (especially Microsoft Word and PowerPoint); skill in Microsoft Excel, Photoshop, Illustrator, EndNote Reference Software, and other scientific graphics software would be helpful. Ability to understand and interpret statistical results of clinical studies; ability to summarize complex results and present them in a clear, concise, and scientifically accurate manner to a wide range of audiences.
Medical Science Liaison (MSL) Autolus TherapeuticsMedical Science Liaison (MSL)MassachusettsThrough scientific exchange establish, develop, maintain, and personalise long term professional partnerships with a broad range of external stakeholders including, but not limited to, healthcare professionals, medical experts, investigators, researchers, pharmacists, payers, opinion leaders in key hospitals, institutions, and organizations. Typical activities of an MSL may include, but are not limited to, providing mentoring, guidance and formal field-training to Autolus colleagues, leading high level projects, executing special projects for the MSL Team Leader and representing the at Regional and Global meetings.
Clinical Systems Business Analyst Integrated Resources, IncClinical Systems Business AnalystLexington, MassachusettsFull timeJob Description: • Provide support within Clinical and other groups as required relating to company's Clinical Trials Management System (CTMS) to support Clinical business process, including design of reports to meet organizational needs, serving as CTMS Administrator, super-user and technical support. • Facilitation of Clinical internal communication and support of external communication of Clinical structure, functions, partnerships, initiatives, and accomplishments to R&D by providing reports and metrics.
Testing Assistant Integrated Resources, IncTesting AssistantBedford, MassachusettsContractorWorks in clean rooms, general lab, autoclave and cold room ranging from 2 to minus 8 degrees Celsius, where specified PPE for each area is required. Education/Experience: · Associate degree with 1-3 years' experience preferable in Biotechnology and or working in a laboratory or life sciences environment.