Senior/Clinical Trial Management Associate, Clinical Operations (Full-Time Employment)

Senior/Clinical Trial Management Associate, Clinical Operations

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.

JOB TYPE: Full-time

LOCATION: San Francisco Bay Area/Hybrid

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.

Qualifications and Experience

• For full-time employment: 35+ 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

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