Parexel FSP is seeking a Senior Clinical Trial Specialist. This is a remote position in the United States.

Key Accountabilities:

Oversight of activities

• Supports activities related to all phase of clinical studies including; study/site feasibility, start-up, maintenance, and close-out. 

• Manages study and site essential documents review, collection, tracking, etc

• Supports the initiation, preparation and maintenance of core study documents (Informed Consent Forms, study plans, site and patient materials, training and guidance documents, pharmacy, clinical supply and laboratory related documents, etc.) 

• Study Trial Master File (TMF) oversight.  

• Ensures required study documents received, reviewed and filed in the TMF in accordance with GCP and applicable regulations.   

• Organization and preparation of study related meetings (agenda/ minutes /slides, etc.) 

• Preparation, oversight and maintenance of study logs (risk/ issue/ decision logs, etc.)  

• Supports and participates in departmental, study team, and service provider related meetings 

• Lead and present at study related meetings  

• Participates in study related collaborative efforts and reviews (protocol development, service provider selection, departmental initiatives, etc.) 

• Complete monitoring visit report review and perform co-monitoring or monitoring oversight visits. 

• Supports, tracks and triages site and service provider queries 

• Supports rapid action to address both internal and site QA findings from audits  

• Manages, coordinate and oversee the activities from third party service providers including timelines, contract deliverables, metrics, accruals, process planning, implementation, etc.  

• General study tracking and maintenance, including but not limited to study status, enrolment,  deviations, study levels documents and plans, etc.   

• Supports oversight of clinical site performance, metrics, monitoring visits, etc. 

• Assist and support study data related activities including data review, query creation and resolution, study and protocol deviation reviews, safety reviews, etc.  

• Able to work cross-functionally  

• Review and verification of service provider activities  

• Supports study reporting and tracking with applicable systems and technology 

• Supports study lead in cross-functional alignment of study timelines 

• Supports study lead in financial management of Service Providers (contract and invoice reconciliation)   

Collaborative relationships 

• Collaborate with cross-functional teams, service providers, and clinical sites to support all phases of clinical studies, from feasibility to close-out, ensuring efficient document management, meeting coordination, and oversight of study activities while contributing to protocol development and departmental initiatives. 

Compliance with Parexel standards 

• Complies with required training curriculum  

• Completes timesheets accurately as required

• Submits expense reports as required

• Updates CV as required

• Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements  

Skills:

• Strong verbal and written communication skills 

• Demonstrated ability to work independently and in a team environment  

• Advanced knowledge of Word, Excel, and PowerPoint.  

• Ability to prioritize and manage multiple tasks simultaneously. 

Knowledge and Experience:  

• 5 or more years’ industry experience from Pharmaceutical, Biotechnology or Contract Research Organization (CRO), to include at least 1 years of site management experience  

• Previous site monitoring experience is preferred  

• Working knowledge in Good Clinical Practices (GCP) regulations and Standard Operating Procedures  

• Understanding of study phases and general knowledge of how they apply to clinical development  

• Working knowledge of electronic Systems including Trial Master File, CTMS, etc. (e.g., Veeva Vault, Smartsheet’s, SharePoint, etc.) 

• Knowledge of the principles and practices of computer applications in database management 

• 15-20% travel may be required

Education:

• Bachelor’s degree preferred  

• Clinical experience is preferred  

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