Major Responsibilities

• 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

Qualification

• 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 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)

上班地址：静安嘉里中心