Job Title: Clinical Trial Specialist
Job Number: 64807
Location: , US
Reporting to a member of the Clinical Operations Team, either the Clinical Operations Lead or a Clinical Trial Leader, the Clinical Trial Specialist will support theClinical Operations team in the overall management of studies, includingplanning, execution, and closeout of one or more assigned clinical trials.
* Assist the Clinical Trial Leader (CTL) with site management activities for assignedclinical trials, including review of monitoring reports, reviewing protocol deviations, and tracking of site visits * Schedule and coordinate study team meetings, materials and agendas; record and disseminate decisions and actions * Assist with preparation of all external and internal documentation for assigned trials, to ensure documentation is completed in accordance withGCP/ ICH regulatory requirements and with thestudy protocol * Create study materials, including newsletters, study templates, etc. under the direction of theClinical Trial Leader * Liaise with CROs and other clinical vendors to ensure deliverables are met and communication is efficient and effective * Identify, address, and communicate quality and compliance concerns, support site payments, maintainstudy FAQ lists and perform quality control review of documents * Organize and maintain tracking systems and tools to support the conduct of clinical study from start-up to close-out * Enter study data into tools and dashboards and ensure information is kept current * Contribute to review of eTMF management including maintenance and oversight * Review and track invoices against the study budget * Assist in clinical operations initiatives including creation and updating of standardizedclinical trial tools, processes and procedures.
The successful candidate will be an innovative and collaborative individual who thrives in a “get it done” type of environment with the following mix of personal and professional characteristics: * 2+ years experience at biotechnology or pharmaceutical company or CRO supportingclinical trials * Minimum B.A./B.S. degree in science/healthcare field preferred * Basic knowledge of drug development and FDA GCP and ICH regulatory guidelines * Preference for a mix of biotech and pharma experience * Excellent oral and written communication, with particular attention to detail * Excellent organizational and problem-solving skills * Ability to multitask * Advanced-level proficiency with MS Word, Excel, Powerpoint and Adobe Acrobat * Familiarity with MS Project, Sharepoint and MSTeams * Demonstrated passion for the Gates MRI’s values with a commitment to deliver results against our mission. * Local and international Travel ~20%
Application Deadline: 2023-10-20