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Clinical Research Associate II / Senior Clinical Research Associate

Clinical Research Associate II / Senior Clinical Research Associate

BeiGeneJapan
18日前
職務内容の詳細

Job Description :

General Description :

  • The CRA executes clinical trial protocols at clinical trial sites and monitors clinical trials by ICH guidelines and GCP, local regulations, and applicable SOPs. The CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Pharma clinical trials within the assigned region(country).
  • Accountable for the study start-up timelines and delivery.

Essential Functions of the job :

  • Conducts monitoring (pre-study, initiation, routine monitoring, and closeout visit), if require
  • Conducts co-monitoring visits, if required
  • Assists with investigator / site identification
  • Assists site to prepare Institutional Review Board / Ethics Committee (IRB / EC) 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 CSMs
  • Provides protocol and related study training to assigned sites
  • Evaluates the quality and integrity of site practices – escalating quality issues as appropriate
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
  • Performs QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services for BeiGene studies
  • Independently deliver clinical start-up component of assigned sites with accountability for time, cost and quality for assigned activities, which include, but not limited to,Investigator / Site identification, including conduct feasibility activity to identify investigators and conduct site visit to confirm qualification for the required study.Prepare, review, submit and QC submissions to Institution Review Board (IRB) to obtain clinical trial authorizations and approvalsPrepare, review, and approve site level critical documents for IP release.Develop and finalize Country and Site-Specific ICFs.Perform site contract / budget negotiation during start-up and maintenance phase. (If required)Review and finalize subject compensation rule and insurance as per local regulations.Review and translate subject recruitment materials as per local regulations if required.Assist CSMs in managing clinical trial during startup phase.
  • Assist in maintain and update company-level investigator database.
  • Establish, maintain and enhance relationship with key opinion investigators and sites.
  • Proactively identify potential issues and seek improvement. Take initiative for issue resolution. Coordinate the risk management process encompassing proactive risk identification, evaluation (probability and impact) and mitigation plans.
  • Performs QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services for BeiGene studies.
  • Perform other duties as assigned by management

    • Description for focusing on Japan :

  • Supports to build Japan organization and required process such as Local SOP and WI.
  • Supports rCSM to perform county activity for new studies if required.
  • Conducts Site Motivation visits.
  • Prepares and supports PMDA inspection.
  • Other tasks, if needed.

    • Supervisory Responsibilities :  Not applicable

    Qualification Required :

    Education Required :

  • BS in a relevant scientific discipline and at least 3 years or more (CRA) monitoring experience in the pharmaceutical or CRO industry
  • Experience in oncology global trials preferred

    • Computer Skills : Efficient in Microsoft Word, Excel, Outlook and other common software.

    Other Qualifications :

  • Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines
  • At least 3 years or more (CRAII) 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)

    • Travel : up to 40-70% time, as required

    What We Offer To Our Valued Employees

  • Market competitive compensation package including performance-based annual bonus scheme
  • Company shares (generous welcome grant and performance-based annual equity plan!)
  • In-house and external learning and development opportunities
  • Fantastic benefits program and keep improving!
  • Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear : Cancer has no borders and neither do we.
  • Join us and Make momentum in your career!

    • BeiGene Global Competencies

    When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking / Data Analysis
  • Financial Excellence
  • Communicates with Clarity

    • BeiGene is committed to respect and protect personal information rights of job applicants and will process job applicants’ personal information in accordance with applicable laws and regulations.

    If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeiGene’s Job

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