Clinical Trial Specialist (Develop Study Plans)

The Clinical Trial Specialist (CTS) is responsible for providing logistical support for one or more 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 Standard Operating Procedures (SOPs) and applicable regulations governing the conduct of clinical trials. The core duties and responsibilities of the CTS include, but are not limited to: Responsibilities: 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 Manages and tracks study specific payments Create study-specific site budgets 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 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 May be responsible for the following activities: Manage ancillary vendors, such as a specialty lab Assist with study-specific training of Clinical Research Associates Perform site initiation, routine monitoring, and close-out visits at a limited number of clinical sites, as well as co-monitoring with Clinical Research Associates Review site visit reports, under the direction of the Clinical Program Manager or designee Negotiate aspects of study-specific site budgets

Requirements / Qualifications: Bachelor degree or equivalent is required (scientific or healthcare discipline preferred) Previous experience in clinical trial coordination and/or site management Understanding of study phases and general knowledge of how they apply to clinical development Working knowledge of ICH Good Clinical Practice guidelines Able to handle multiple tasks and deadlines? Must be self-motivating and able to work on problems of moderate scope and complexity where analysis of situations or data requires a review of a variety of factors Able to identify issues and take appropriate actions Highly effective verbal and written communication skills Must have the ability to build and maintain positive relationships with management and peers Experience using computer applications including spreadsheets, email, word-processing software and web-based systems 10% travel may be required