• 招聘类型：社招
• 工作性质：全职
• 直属部门：Clinical Operations

职位描述

Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit), if require.Conducts co-monitoring visits, if required.Conducts Quality Oversight Visits (QOV), as requested.Completes monitoring visit/ QOV reports timely.Assists with investigator/site identification.Assists site to prepare Ethics Committee submissions.Facilitates clinical trial site contract and budget negotiation .Manages site queries and communications.Assists in managing clinical trials, if required.Establishes regular lines of communication with sites and COMs.Provides protocol and related study training to assigned sites.Evaluates the quality and integrity of site practices – escalating quality issues as appropriate.Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution

任职条件

Bachelor’s level degree or above in life sciences, pharmacy, nursing or medical.Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines.3 years or more (SCRA)/ 8 years or more (PCRA) monitoring experience in the Pharmaceutical or CRO industry .Excellent communication and interpersonal skills .Excellent organizational skills and ability to prioritize and multi-task .Fluent in English (writing and speaking)

职位要求

• 学历要求：无
• 工作经验：无
• 外语要求：不需要