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Senior Clinical Trial Specialist

Company: Planet Pharma
Location: Stratford
Posted on: January 9, 2022

Job Description:

Senior Clinical Trial Specialist
The Senior Clinical Trial Specialist (CTS) is responsible for providing logistical support for multiple clinical trial programs. This position will work closely with cross-functional teams to ensure site start-up through close-out activities are conducted in accordance with SOPs and applicable regulations governing the conduct of clinical trials.
Responsibilities of the Senior CTS include, but are not limited to:
--- Actively involved in the performance of study feasibility assessments--- Develop and review study documents (e.g., site instructions, diaries, lab manual, Pharmacy Binder, Study Management Plan, etc.) and clinical site documents (e.g., site specific informed consent forms)--- Manage the collection, review and approval of regulatory documents from clinical sites--- Coordinate investigational product release activities across clinical sites--- Initiate, maintain and reconcile the Trial Master File--- Assists in the preparation of Investigator and Study Coordinator Meetings--- Set-up and maintain tracking systems (e.g., CTMS), tools and report study metrics to support the clinical trial programs--- Manages and tracks study specific payments--- Create study-specific site budgets--- Coordinate communication of tracking information within the study team and to the clinical sites--- Develop and review Standard Operating Procedures--- Serve as a subject matter expert for the CTS role on initiatives and working groups--- Mentor Clinical Trial Associates and peer CTSs, including the onboarding of new hires--- May be responsible for the following activities:o Manage ancillary vendors, such as a specialty labo Assist with training the Clinical Research Associateso Perform site initiation, routine monitoring and close-out visits at a limited number of clinical sites, as well as co-monitoring with Clinical Research Associateso Review site visit reports, under the direction of the Clinical Program Manager or designeeo Negotiate aspects of study-specific site budgets
Requirements:--- 8+ years of Clinical Trial experience. Fully proficient in clinical trial coordination--- Bachelor degree or equivalent is required (scientific or healthcare discipline preferred)--- Understanding of study phases and general knowledge of how they apply to clinical development--- Working knowledge of ICH Good Clinical Practice guidelines--- Experience using computer applications including spreadsheets, email, word-processing software and web-based systems

Keywords: Planet Pharma, Visalia , Senior Clinical Trial Specialist, Healthcare , Stratford, California

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