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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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.