Aboutthe Role
We are seeking a ResearchAssociate with pharma industry and/or clinical experience to help shape anddeliver on the future direction of our product. We are looking for a highlymotivated individual to join our growing start-up team and work from our NewYork office.
MajorResponsibilities
§ Support projects throughout the entire projectlife-cycle, from developing the scope, schedule and project requirements throughto delivering the project on time and on budget
§ In depth knowledge of ICH/GCP, regulatoryguidelines/directives, and drug development and clinical research processes
§ Time management skills – ability toeffectively prioritize
§ Run effective meetings with clear agendas,goals and outcomes
§ Create study documents including but notlimited to: Informed Consent, Case Report Forms, letters to the Clinical Sitesand Principal Investigators
§ Proactively identify obstacles, risks and gapsin the project plan and process; suggest solutions on how to resolve them
§ Assess existing processes and identifyopportunities for improvements to promote collaboration and efficientimplementation across the different functional teams and with external vendors
§ Support the strategic and tactical businessplanning annual process, implementation, and monitoring across the business
§ Support cross functional projects
§ Manage and initiate execution on all phases ofassigned initiatives, working with appropriate team members and differentfunctional areas as necessary
§ Manage all communications with Clinical Sites
§ Effectively collaborate with team members onmethodologies best practices
§ Study Tools including electronic system skills– CTMS / EDC/eTMF, etc
Job Type: Full-time
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