Gates Medical Research Institute
Job Title: Clinical Trial Specialist
Job Number: 28558
Location: 245 Main St Cambridge, MA 02142
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 the Clinical Operations team in the overall management of studies, including planning, execution, and closeout of one or more assigned clinical trials.
- Assist the Clinical Trial Leader (CTL) with site management activities for assigned clinical 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 with GCP/ ICH regulatory requirements and with the study protocol
- Create study materials, including newsletters, study templates, etc. under the direction of the Clinical 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, maintain study 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 standardized clinical 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 supporting clinical 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%
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