Clinical Research Associate / Senior Clinical Research Associate

  • Company:
    BeiGene
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    2 days ago
  • Category:
    Scientific

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Job Description: Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit), if require Conducts co-monitoring visits, if required Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.) Attends onboarding-, disease indication and project specific training and general CRA training as required Documents monitoring activities appropriately following ICH-GCP and BeiGene standards 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 Collaborates with CRA Group / CRM to ensure recruitment plans and execute contingency plans, as needed Performs additional task as assigned Qualification Required: 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 1-3 years or more (SCRA) monitoring experience in the pharmaceutical or CRO industry 7+ years monitoring experience in the pharmaceutical or CRO industry (PCRA) Excellent communication and interpersonal skills Excellent organizational skills and ability to prioritize and multi-task Fluent in English (writing and speaking) Follow Us on MoSeeker!