Clinical Study Associate II

Overview

Support clinical study execution and coordination across multiple trials remotely.

Key Responsibilities

• vendor coordination
• sample management
• tmf tracking
• data flow
• site startup
• document prep

Tasks

-Assist in reviewing site budgets/contracts and coordinating third-party vendor activities. -Monitor patient status, sample collection, lab shipments, and vendor coordination. -Track essential documents in the TMF and review site submissions for accuracy/completeness. -Assist with site start-up, enrollment tracking, monitoring oversight, and data flow management. -Serve as a liaison with CROs, investigative sites, and internal teams for sample handling, reporting, and issue resolution. -Review monitoring reports, data queries, and site performance metrics. -Support feasibility assessments, investigator meetings, vendor meetings, and overall study logistics. -Study Managers open to performing CSA responsibilities are welcome to apply. -Prepare and maintain key study documents (ICFs, site instructions, manuals, pharmacy binders). -Attend site visits and participate in co-monitoring activities. -Support the Clinical Operations Study Lead across all areas of trial execution.

Requirements

• bachelor's
• pharma
• gcp
• excel
• phase 4
• self-starter

What You Bring

A growing Clinical Operations group is seeking a Clinical Study Associate II to support multiple clinical studies within a high-visibility clinical program. This is a 6-month contract opportunity with the flexibility to work fully remote (candidates in the Cambridge/Boston area are preferred). Clinical Study Associate II – 6-Month Contract (Fully Remote, Cambridge/Boston Preferred) -Bachelor’s degree in a scientific or related discipline required. -3–5 years of experience in pharma, CRO, or clinical research—CSA background strongly preferred. -Medical/scientific experience in clinical research. -Self-starter who takes initiative, identifies opportunities, and drives deliverables with minimal oversight. -Phase 4 experience is a plus. -Resourceful, flexible, and adaptable to shifting priorities in a fast-paced environment. -Highly organized with excellent multi-tasking skills and attention to detail. -Strong communicator and collaborative team player. -Strong grasp of GCP, SOPs, and clinical study phases. -Ability to take tasks directly from a study lead and work independently under aggressive timelines. -Experience in monitoring, study coordination, or data handling. -Proficiency with Word, Excel, PowerPoint, and basic database management. -CRO, industry, or site-level experience—any are acceptable with relevant clinical background.

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About Tundra Technical Solutions

-Began as a niche IT staffing provider and has grown into a global talent solutions firm. -Serves both contingent and permanent hiring needs, encompassing managed service provider (MSP), recruitment process outsourcing (RPO), and direct-source curation. -Project portfolio spans complex IT infrastructure, cybersecurity, software development, and ERP deployments in public and private sectors. -Pioneered employer-branded talent communities, combining curated talent pools with VMS integration for cost and time efficiencies. -Standout partnerships include global direct-sourcing with LiveHire and recent alliances to boost diversity initiatives and green-collar staffing. -Holds ISO 9001 certification.

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