inVentiv Health SCRA | Eastern Seaboard, Australia in Eastern Seaboard, Australia

Organization Overview inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of much-needed therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) offer a differentiated suite of services, processes and integrated solutions that improve client performance. With more than 15,000 employees and the ability to support clients in more than 90 countries, our global scale and deep therapeutic expertise enable inVentiv to help clients successfully navigate an increasingly complex environment. For more information, visit inVentivHealth.com

Title SCRA | Eastern Seaboard, Australia

Job ID 15246

Responsibilities

  • 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

Requirements

  • 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 Eastern Seaboard

Country Australia [AU]