commercial launches. As needed, provide clinical and technical expertise for clinical trial procedure support Attend study... territory: Identify, develop, and maintain sites capable of delivering start-up goals, study participation levels...
Position Summary: Department: Research and Clinical Trial Shift: Day/Full Rime Location: Orlando Fl - Corp... clinical trials research studies conducted by a supervising principal investigator(s) in support of activities that meet...
Job Description: Position Summary Department: Research and Clinical Trial Shift: Day/Full Rime Location... clinical trials research studies conducted by a supervising principal investigator(s) in support of activities that meet...
deliverables are completed on time and in accordance with quality standards and regulatory requirements from study start-up through... role in delivering high quality, inspection-ready clinical trial data across Alumis' development programs. This role...
Director, Country Operations Management (AD COM), you will report to the Director, Study Start-Up and Site Partnership and play... manager for designated local functions, as agreed with the Study Start-Up and Site Partnership Director...
and Follow-up Assists in tracking study participation and retention over time Reviews data using software including REDCap... Required Qualifications Bachelor’s degree Experience with projects involving human subject research and clinical trial work...
Director, Country Operations Management (AD COM), you will report to the Director, Study Start-Up and Site Partnership and play... manager for designated local functions, as agreed with the Study Start-Up and Site Partnership Director...
teams to improve performance and resolve obstacles during site start‑up and study execution. Create and implement... to better prepare the arrival of clinical trials Provide strategic input for operational excellence, process efficiency and trial...
will oversee multiple aspects of clinical trial conduct including study start-up, document generation and review, tracking... study-related or essential study start-up documents as they relate to the supported clinical trials as delegated by the...
Behaviors (CARE) at the University of Kansas ( ) is seeking an Associate Researcher to support its multidisciplinary program... years, with the possibility of additional long-term follow-up funding. The Associate Researcher will receive...
of all aspects of drug safety study operational activities from study start up to close out. ESSENTIAL DUTIES AND RESPONSIBILITIES... protocols and participation on IND Annual Reports in support of the Drug Safety Physician. Development of study specific...
with Clinical Operations, Clinical Science, Commercial, Study Start-Up, etc. to integrate feasibility insights into study planning... and/or indications. Deep knowledge of clinical trial design, patient recruitment challenges, and global study execution. Proficiency...
knowledge of multiple inventory methodologies to collaborate with Clinical Trial Study Management and facilitate optimal Supply..., if required, and respond to customers in a timely manner; act as primary resource for Help Desk personnel for study set-up and support...
institution. 5 or more years of clinical research experience with study start-up experience within a contract research... and successfully executes all aspects of study start-up and maintenance which includes but is not limited to initial site outreach...
. · Prepares and submits start-up regulatory packets to Sponsor and IRB. · Assists leadership with expeditated study launch... with study start up activities to include reporting and communicating with Sponsor, IRB, and site. · Serve as a liaison...
study fiscal records in the Clinical Trial Management System, complete monthly invoicing, study reconciliation and reporting..., calculating potential profit margins, etc. Effectively and independently negotiate clinical trial budgets with study sponsors...
consent forms Lead study start-up: prepare and submit all required regulatory documents for new study applications... team providing regulatory support to Principal Investigators (PIs) and research study teams focused on mission-critical...
on regulatory documents With input from PI(s), draft initial clinical research trial informed consent forms Lead study start-up... bodies (IRB, Clinical Research Support, Regulatory Affairs, etc.) Stay abreast of new impacts/areas of knowledge...
, communication, and change-management skills. Demonstrated experience overseeing study start-up, research contracting, coverage... lifecycle—including start-up, contracting, budgeting, grants, financial management, compliance, and analytics—for more than 400...
on regulatory documents. With input from PI(s), draft initial clinical research trial informed consent forms Lead study start-up... regulatory bodies (IRB, Clinical Research Support, Regulatory Affairs, etc.). Stay abreast of new impacts/areas of knowledge...