Clinical Operations Specialist – Pool

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🕒 April 11

🏄 California – Remote

🏄 California – Remote

💵 $85k - $95k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🏥 Clinical Operations

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Vanguard Clinical, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2012

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

Vanguard Clinical, Inc. is a boutique Contract Research Organization (CRO) and Functional Service Provider (FSP) that specializes in providing tailored services for clinical trial execution. With a focus on flexibility, transparency, and high-quality service, Vanguard Clinical partners with sponsor companies to manage their clinical development projects effectively. The company emphasizes careful handling of clients' assets, regulatory compliance, and optimal project management, offering a range of services from clinical monitoring and data management to patient recruitment and quality assurance.

📋 Description

• The Clinical Operations Specialist (COS) is an experienced, cross-functional clinical research professional responsible for supporting and driving key operational activities across Clinical Operations, Study Start-Up (SSU), Trial Master File (TMF) Management, Data Management, Vendor Oversight, Site Support, and broader study execution. • Lead administrative and operational coordination across the clinical trial lifecycle. • Independently manage study trackers, site updates, enrollment metrics, and operational reporting. • Prepare agendas, lead or co-lead portions of meetings, and finalize high-quality minutes and action items. • Coordinate cross-functional workflows with CRAs, PMs, Data Management, SSU, Safety, and TMF teams. • Provide proactive solutions and anticipatory support to internal teams and Sponsor clients. • Independently manage essential document collection, QC, and readiness for site activation. • Conduct feasibility outreach, site qualification support, and site-level intelligence collection. • Lead start-up timeline tracking and drive accountability with sites and vendors. • Perform advanced QC review for TMF documents and root-cause identification for recurring issues. • Independently manage TMF filing, metadata application, and cross-checking for document dependencies. • Support audit/inspection readiness, including TMF remediation, reporting, and corrective action follow-up. • Perform high-level clinical data review in EDC systems; generate and track complex queries.

🎯 Requirements

• Minimum 3 years of clinical research industry experience, preferably within a CRO, sponsor, or academic research setting • Proficiency with clinical systems such as eTMF, EDC, CTMS, IWRS, or study tracking tools • Strong working understanding of ICH-GCP, GDP, and clinical research processes across start-up to close-out • Demonstrated ability to independently manage multiple tasks and deadlines with minimal supervision • Flexibility and adaptability to support diverse client needs • Strong customer service mindset with a solutions-oriented approach • Demonstrated strengths in planning, organization, time management, problem solving, and attention to detail • Excellent oral and written communications and presentation skills; ability to communicate effectively with vendors and clients • Detailed knowledge of Microsoft Office suite of software programs.

🏖️ Benefits

• health insurance • 401k retirement plan • paid days off • annual performance bonus