Job Summary:
The Senior Clinical Trial Specialist (Sr CTS) supports moderately complex clinical trial activities in support of the Clinical Trial Manager(CTM). The Sr CTS works closely with the clinical trial team to ensure trial activities are conducted according to Good Clinical Practice (GCP) and relevant SOP's. The Sr CTS may assist with Service Provider oversight and management. They will identify issues in a timely manner and escalate to management as appropriate. They will support the CTM in ensuring the financial health of assigned clinical studies as well as oversight of study milestones. The core duties and responsibilities of the Sr CTS are delineated below.
Essential Functions:
- 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)
Necessary Knowledge, Skills, and Abilities:
- 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
- Demonstrated ability to work independently and in a team environment
- Advanced knowledge of Word, Excel, and PowerPoint.
- 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
- Strong verbal and written communication skills required.
- 15% - 20% travel may be required
Educational Requirements:
- Bachelor's degree preferred
- Clinical experience is preferred