Clinical Operations Associate

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🕒 April 11

🏄 California – Remote

🏄 California – Remote

💵 $70.3k - $80k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🏥 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

• Provide administrative and operational support across the clinical trial lifecycle. • Track study metrics (enrollment, screening, recruitment, site updates). • Assist in preparing and documenting meeting materials. • Schedule and coordinate meetings. • Prepare, ship, and track investigational products and study supplies. • Support collection, tracking, and review of essential documents. • Assist with feasibility, qualification, and regulatory document management. • Support IRB/EC submissions and ICF preparation. • Track study start-up timelines and follow up with sites and vendors. • Perform QC review of TMF documents. • File documents per TMF Reference Model. • Identify gaps, inconsistencies, and missing documentation. • Support audit and inspection readiness. • Review and enter clinical data into EDC systems. • Manage data queries, reconciliation, and quality control checks. • Support documentation review and source verification activities. • Provide customer service to clients, vendors, and sites. • Draft or update trackers, presentations, and study reference materials. • Support cross-functional initiatives and process improvements. • Participate in study meetings and assist with follow-up actions.

🎯 Requirements

• Strong self-motivation, ability to work independently, and quickly learn new information and skills • Demonstrated strengths in planning, organization, time management, problem solving, and attention to detail • Strong organizational skills, the ability to manage multiple priorities, and produce accurate and timely work • Excellent oral and written communications and presentation skills; ability to communicate effectively with vendors and clients • Basic understanding of US clinical research process, FDA, regulations, and ethical guidelines preferred • Detailed knowledge of Microsoft Office suite of software programs: • Microsoft Outlook including shared calendars & invitations • Microsoft One Drive and Share Point • Microsoft Power Point • Microsoft Excel • Document change tracking & version control • Preferred: Familiarity with GCP/GDP/ICH guidelines • Experience with eTMF, EDC, CTMS, or document management systems • Prior exposure to clinical research

🏖️ Benefits

• health insurance • 401k retirement plan • paid days off