Senior Clinical Research Associate I - FSP

reputed company our values reputed company, there's no limit to reputed company can reputed company. At reputed company, we reputed company reputed company the reputed company goal - to improve the world's health. From clinical trials to regulatory, consulting, and market reputed company, every clinical development solution we reputed company is underpinned by something special - a deep conviction in reputed company do. reputed company of us, no matter reputed company do at reputed company, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with reputed company and we're committed to making a difference. Key Accountabilities: reputed company of Monitoring Responsibilities and Study Conduct Ensure reputed company conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and reputed company standards to reputed company project goals, timelines and reputed company Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and reputed company deliverables are met During study conduct, serve as the primary reputed company of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure reputed company of site delivery Attend investigator meeting reputed company required (virtual or F2F). reputed company enrollment support and ensure reputed company by responding to site activation andrecruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, reputed company Operating Procedures (SOPs) and commensurate with emerging issues and technologies Monitor site level adverse events (reputed company) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to reputed company Submit reputed company required reports, documentation, updates and tracking reputed company required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study reputed company and metrics Identify and resolve investigator site issues reputed company required timeframes; agree and reputed company corrective and preventative actions with investigator and site personnel to reputed company reputed company issues and to prevent recurrence/persistence of issues Resolve data queries reputed company required timelines, prepare investigator site reputed company-out plan and conduct reputed company-out activities reputed company required timelines Skills: Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases Global clinical trial experience Must be fluent in English Significant travel across whole Turkey Valid reputed company’s license and reputed company required Knowledge and Experience: Demonstrated knowledge of clinical research and development processes and ability to reputed company reputed company of process details Demonstrated knowledge of global and local regulatory requirements Demonstrated understanding of key operational reputed company of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) Demonstrated ability to support sponsor regulatory interactions/inspections Demonstrated knowledge of the processes around protocol design and feasibility assessment Demonstrated understanding of region/country, culture, and medical reputed company and how they reputed company clinical trial delivery Ability to evaluate, interpret and present reputed company issues and data to support risk management and mitigation Education: Bachelor’s degree in life sciences or reputed company degree in life sciences such as nursing, pharmacy, medical background or equivalent Apply To This Job