inVentiv Health Senior Clinical Research Associate (Sr CRA), Malaysia in Kuala Lumpur, Malaysia

Title Senior Clinical Research Associate (Sr CRA), Malaysia

Job ID 12897


  • Perform routine site visits, including Pre-study, initiation, routine and closeout visits. Visits to include monitoring or proper informed consent procedures, compliance and assurance of good site performance

  • Document each visit with a quality written monitoring visit report and submit to the reviewer for review and approval within contractual guidelines

  • Author and send follow up letter to investigative site documenting the visit and any outstanding items to be addressed within contractual timelines

  • Review and approve monitoring visit reports ensuring finalization within contractual obligations

  • Assist Project Managers in study execution by acting as Lead CRA I projects and facilitating communication with Clinical Monitoring team

  • Perform monitoring evaluation visits with CRAs

  • Develop and facilitate training for colleagues on clinical, regulatory, administrative and company procedures and process

  • Develop study specific tools for tracking and reporting for Clinical Monitoring team

  • Participate in feasibility studies

  • Develop and write Clinical Monitoring Plans

  • Present study materials at investigator/study launch meetings when required

  • Support project management team with assessment of workload and site assignments within the project team

  • Assist project management team with review of monitoring reports and study documents when required

  • Participate in company required training programs

  • Participate on BID defense meeting

  • Perform necessary administrative functions ( e.g. submission of expense reports, entering time)

  • Train/Mentor junior CRAs on monitoring, internal procedures, and query resolutions.

  • Performed regulatory activities, if applicable


  • Bachelor’s Degree or nursing credential

  • Minimum four and a half years experience in clinical monitoring experience

  • Extensive knowledge of GCP/ICH Guidelines and other applicable regulatory requirements

  • Demonstrated proficiency in problem solving, juggling multiple priorities and a commitment to quality and customer focus

  • Proven ability to work independently in a fast paced environment

  • Strong communication, interpersonal and organizational skills. Mentoring capabilities

  • Must demonstrate good computer skills

  • Ability to provide clear direction and guidance to other

  • Position requires approximately 60% travel

City Kuala Lumpur

Country Malaysia [MY]