Senior Clinical Research Associate - FSP

*글로벌 스폰서 데디팀 CRA 채용*

*CRA 경험 4년 이상*

*글로벌 온코 과제 경험 2년 이상*

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 

•  Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites 

• Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks 

• Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment 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

• Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities 

•  Support database release as needed

• May undertake the responsibilities of an unblinded monitor where appropriate

Clinical/Scientific and Site Monitoring Risk

• Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team

• Interact with investigator site heath care professionals in a manner which enhances the client’s credibility, scientific leadership and in order tofacilitatethe client’s clinical development goals 

•  Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators 

• Drive Quality Event (QE) remediation, when applicable 

• Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable

Collaboration

• Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) 

• Partners with SCP and Country Study Operations Manager (SOM) 

• When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) 

• May act as a Mentor for Clinical Research Associates

Compliance with Parexel standards

• Complies with required training curriculum 

• Completes timesheets accurately as required

• Submits expense reports as required

• Updates curriculum vitae (CV) as required

• Maintains a working knowledge of and complies with Parexel processes, International Conference on Harmonization (ICH) - GCPs, and other applicable requirements