Study Specialist

Are you an experienced Study Specialist with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Study Specialist to work at their company in San Rafael, CA(Hybrid San Rafael 2 days/week or Remote if >100 miles).Position ** The Study Specialist II (SS-II) contributes to or leads tasks related to the oversight of site monitoring, site management and/or vendor management, and other activities as delegated by the Study Manager. This may include contributing to and/or supporting study-related matters that impact study timelines, quality, and budget. Within the role, the candidate is expected to show and have proficient knowledge and experience in the following *Responsibilities include but are not limited *Develop and/or review study specific documentation, as delegated by the Study ManagerContribute to the management of country and site feasibility assessmentProvide support in the management of Regulatory document collection and tracking (in the absence of a CRO) for participating sitesContribute to the collection and oversight of essential documents for study life-cycle managementContribute to the development of site and investigator training materialsMay present at investigator meetings as assignedEnsure timely study entry and updates to ClinicalTrials.govEnsure investigator ** site set-up, pass-through processing, visit payment processing and funding processing (in collaboration with payment vendor)Provide administrative assistance with internal and external meetings including investigator meeting(s) as warrantedFacilitate Screening Authorization Forms tracking/sign off where applicableManage various Global Study Operations document translations as applicableProcess documents for signature in DocuSignSite management for delegated site(s)Manage and resolve site related issues and risks escalated to client that cant be resolved by CRO.Contribute to identifying risks identification and mitigationsOversee the Clinical Trial Insurance processSupport Study Manager to ensure timely delivery and handling of IP to the sitesSupport Vendor ManagementAttend internal Global Study Operations team meetings, vendor meetings, and/or Cross-Function Study Execution Meeting(s) as GSO representative and take meeting minutes as requested.Oversee and manage essential documents in the Trial Master File (TMF)Contribute to Global Study Operations risks identification and mitigations.Provide support and administrative assistance with internal and external meetingsAssist with filing GSO internal study documents in internal systems*****BS or higher in nursing, life or health sciences is preferredIndustry or relevant experience in lieu of education may be consideredExperience in oversight of external vendors (e.g., CROs, central labs, imaging vendors, etc.)Study Management and ExecutionCompliance and QualityDrug Development and Study DesignProduct and Therapeutic Area KnowledgeAgility and ProactivityCommunication and Collaboration

Created: 2024-11-06