• , US

Company:  Confidential

Job Title: Clinical Trial Specialist

Job Number: 80251

Location: , US

Job Description

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. 

Responsibilities

* 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.

Required Skills

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: 2024-08-19

 

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