||・Monitors activities conducted by clinical investigative sites as they relate to our clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity.
・The Senior Site Clinical Research Associate (Sr.SCRA) conducts clinical site monitoring visits across a maximum of 5 protocols and multiple therapeutic areas, ensuring our studies are conducted according to all applicable regulations and business processes.
・Ensures regulatory inspection readiness at assigned clinical sites. May be responsible for assignments of greater complexity than the Clinical Research Associate (i.e., greater number of sites, site participating in more complex clinical studies, sites requiring more oversight of operational issues).
・Additionally, the Sr. SCRA may train and provide guidance to junior staff.
・Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
・Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and our Standard Operating Procedures (SOPs) and business processes.
・Conducts all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to:
・Manages and monitors the activities of clinical investigative sites across a maximum of 5 protocols and multiple therapeutic areas with the ability to manage, with minimal supervision, sites participating in more complex clinical studies and/or sites requiring more oversight of operational issues, than those assigned to SCRAs.
・Overviews the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives.
・Facilitates Quality Assurance Audit processes as indicated.
・Bachelor’s Degree required; medical/science/nursing background is preferred.
・Minimum of 3 years of clinical related experience, with a minimum of 2 years as clinical research monitor.
・Experience in on-site monitoring of investigational drug in multi-therapeutic areas desired.
・Working knowledge and experience with electronic data capture systems and clinical trials management systems.
・Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
・Excellent knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
・Proven strong site management and monitoring skills
・Exhibits strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
・Strong ability to work independently in a geographic region with minimal supervision.
・The Sr SCRA anticipates and proactively solves study-related clinical site issues as they occur and initiates, recommends and communicates corrective action as indicated. The Sr SCRA should use functional expertise and exercise good judgment in seeking appropriate guidance and ensures that follow-up to any and all corrective action is taken at the clinical site and is properly documented.
・Excellent written and verbal communication skills. Written and verbal fluency in English and local language (if not English).
・Proficiency in the use of personal computers, including experience with word processing, spread sheets, email and web-browser applications
・Acute observational skills, analytical and conceptual capabilities.
・Exhibits high degree of flexibility when facing changes in the work environment.
・Attention to detail and strong interpersonal skills.
年 収：年俸制、昇給年１回 （採用ポジションにより年収パターンあり）