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Senior/Clinical Trial Management Associate, Clinical Operations (Full-Time Employment)
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JOB TYPE: Full-time
LOCATION: San Francisco Bay Area/Hybrid
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Riboscience is seeking passionate, creative, and dedicated individual to join our team as an Sr/Clinical Trial Management Associate who has technical expertise in supporting Phase I-III clinical trials in an industry setting.
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QUALIFICATIONS AND EXPERIENCE:
For full-time employment: 3–5+ Years of relevant experience in pharmaceutical, biotechnology, CRO and/or healthcare setting
BA/BS degree in relevant scientific discipline
Strong knowledge of clinical trial operations, Good Clinical Practice (GCP) guidelines and U.S. Food and Drug Administration (FDA) and other applicable regulatory requirements
Prior clinical trials/operations experience in company-sponsored clinical trials required
Oncology experience preferred
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ABOUT RIBOSCIENCE
Riboscience is a clinical stage biotechnology company developing treatments for serious infectious diseases and cancer. We apply ribose and structure-guided design technologies to the discovery of drugs that target proteins that are essential and unique to specific infectious pathogens, tumor cells or the anti-tumor immune response. We are looking for diverse talent to join our team and share with us the passion and excitement in making highly impactful new medicines available to patients with severe infectious diseases or cancer. Riboscience is headquartered in the San Francisco Bay Area with locations in Sunnyvale and Palo Alto.
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ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
Support Clinical Operations Study Lead/Clinical Trial Manager (CTM) in the drafting/review of protocols, informed consents, case report forms, monitoring plans, or clinical study reports
Support and implement trial set-up, execution, generating reports for clinical studies
Independently perform tasks related to the day-to-day clinical trial management with the implementation and conduct of clinical trials, enrollment, site management and monitoring oversight, data quality and study reporting
Collect, track and conduct initial review for completeness of site regulatory documents for investigational product release and/or TMF filing, with CTM oversight
Support and/or contribute to the creation and maintenance of study materials, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans/manuals, site tools, study communications and presentations
Manage third-party vendor with CTM oversight to ensure timely delivery of services/materials and coordinate activities, including vendor provided meeting minutes, study updates and trackers
Maintain trackers following the progress of assigned clinical trials, such as study subject tracking, essential document tracking
Tracking trial investigational product, clinical lab samples and lab data, sample shipments and reconciliation with sites, as needed
Support CTM/Sr CTM in the review, tracking and follow-up of monitoring visit reports and unresolved issues
Collect and collate site feasibility data
Facilitate the execution of new CDAs and site contracts through the established legal approval process (CTAs, MSAs, work/task orders)
Perform first pass review of site and some vendor invoices including tracking and generation of monthly/quarterly accruals
Communicate directly with sites, Contract Research Organizations (CROs) and field CRA/monitors to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close-out activities
Responsible for the scheduling, agendas and minutes of internal clinical team meetings and other trial-specific meetings
Receive and review regulatory documents from sites (direct or through CRO) for accuracy and compliance with applicable SOPs and regulatory guidelines
Ensure timely updates of required trial registry websites, with CTM oversight
Support the team in the development, review and implementation of departmental SOPs and processes
Organize, maintain and participate in the audit and close out of the Trial Master File (TMF/eTMF)
Participate in the EDC / IRT specification and user acceptance testing (UAT) processes, as appropriate
Other duties may be assigned
Strong, professional written and verbal communication skills, good organization and attention to detail, and the ability to consistently provide high quality work while managing competing priorities and maintaining tight timelines
Must be interested in working in a fast-past and team-oriented environment with the ability to effectively collaborate with the study team, cross-functional team members, and external partners
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HOW TO APPLY
Please send a cover letter and a copy of your CV to
[email protected]
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