Senior Clinical Research Associate I - FSP

Key Accountabilities:

Oversight of Monitoring Responsibilities and Study Conduct

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality  

• 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 quality deliverables are met  

• During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery  

•  Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress 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, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies  

• Monitor site level adverse events (AEs) 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 resolution  

• Submit all required reports, documentation, updates and tracking within 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 progress and metrics  

• Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues  

• Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within 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 driver’s license and passport required 

Knowledge and Experience:

• Demonstrated knowledge of clinical research and development processes and ability to gain command of process details  

•  Demonstrated knowledge of global and local regulatory requirements  

• Demonstrated understanding of key operational elements 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 practice and how they affect clinical trial delivery 

• Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation  

Education:  

• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent