• Contribute to the overall management of one or more clinical trials, supporting planning, execution, and closeout activities with increasing autonomy and ownership of assigned workstreams.
• Serve as a key operational point of contact for internal and assigned external study personnel (e.g., investigative sites, vendors), ensuring clear, timely communication and proactive follow-up.
• Support Sponsor oversight of site management activities, including review of monitoring reports, tracking of site visits, and identification/escalation of site-level issues or trends.
• Coordinate study team, vendor, and site meetings, including scheduling, agenda preparation, minute-taking, and distribution.
• Maintain and enhance sponsor-owned study trackers, tools, and dashboards, and review CRO-maintained trackers and reports for accuracy, completeness, and timeliness; coordinate resolution of discrepancies and identify opportunities to improve processes, data quality, and reporting efficiency.
• Maintain sponsor-owned study records and support oversight of CRO-maintained CTMS and TMF records, performing ongoing TMF quality reviews and reconciliation activities, identifying gaps and coordinating resolution in collaboration with Clinical Trial Manager (CTM)
• Support Vendor Oversight by reviewing status reports, tracking contracted deliverables, timelines, performance, and documentation, and following up on outstanding action items.
• Support vendor selection and contracting activities, including scope-of-work reviews and contract routing
• Identify, troubleshoot, and communicate quality and compliance risks; support implementation of corrective Perform quality control review of study documents and support operational aspects of site payments.
• Contribute to the development, review, and maintenance of study operational plans and documents; coordinate collaborative review; track reviewer feedback, consolidate comments, and maintain version control.
• Participate actively in the review of core study documents (e.g., protocol, IB, CSR) and provide operational input.
• Actively participate in cross-functional project team meetings; capture key decisions, action items, and risks, and drive follow-up to
• Support development of study and departmental presentations and increasingly contribute to content development
• Assist with site monitoring activities, audit and inspection preparation, and support inspection readiness activities

Qualifications:

• Bachelor’s degree with at least 3+ years of clinical research experience; experience supporting sponsor or CRO clinical operations preferred
• Working knowledge of ICH GCP and its application to clinical trial documentation and operations.
• Strong organizational skills and attention to detail, with the ability to maintain accurate records and manage competing priorities and deadlines
• Demonstrated ability to take ownership of assigned tasks, proactively follow up, and drive action items to completion
• Strong written and verbal communication skills.
• Ability to participate and work effectively on multiple cross-functional teams with increasing independence, incorporating feedback and seeking guidance when needed
• Proficiency with Microsoft Office and experience using SharePoint or OneDrive to manage shared documents and coordinate review.

Salary Range:

$100,000- 120,000 USD