Senior Clinical Research Associate

🕒 September 11

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

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👻 Ghost score 11%

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Everest Clinical Research

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2004

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Everest Clinical Research is a global contract research organization (CRO) that provides end-to-end clinical trial services and biometrics expertise to pharmaceutical and biotechnology sponsors. The company offers clinical operations and project management, risk-based quality management and centralized monitoring, medical monitoring, pharmacovigilance, clinical data management, biostatistics and statistical programming, regulatory strategy and submissions, and technology solutions such as IRT/RTSM and ePRO/eCOA. Everest positions itself as a high-touch, quality-driven partner with global reach and therapeutic expertise across oncology, neurology, respiratory, rare diseases and immunology.

📋 Description

• Perform clinical trial monitoring activities, including monitoring, reporting, and tracking study progress • Review Investigator Site Files for accuracy and timely reporting to the central Trial Master File repository • Assess clinical trial compliance with regulatory requirements, protocols, monitoring plans, and SOPs • Interact with sponsors, investigational sites, vendors, and Everest functional groups • Identify potential clinical trial sites and perform feasibility and Pre-Study Visits • Participate in Investigator Meetings and CRA/Study Coordinator training sessions • Assist sites with study-related questions • Provide feedback on study manuals, case report form guidelines, monitoring plans, informed consents, recruitment materials, and monitoring tools • Perform Site Initiation, Interim Monitoring, and Close-Out Visits • Submit Monitoring Visit Reports and follow-up letters through the Clinical Trial Management System • Assist with precept/oversight visits and review/approval of CRA I/II monitoring visit reports • Review and reconcile Investigator Site Files and Trial Master Files • Ensure sites submit relevant documents to Institutional Review Boards/Ethics Committees • Maintain ISF/TMF in an inspection-ready state • Establish communication and provide ongoing protocol/study-related training to assigned sites • Ensure continuous data flow, including site data entry, query resolution, and source document verification • Assess patient recruitment and retention and suggest improvements • Ensure proper handling and reconciliation of investigational products, medical devices, and clinical trial supplies • Prepare sites for regulatory, sponsor, or CRO inspections/audits • Submit accurate and timely expense reports • Assist with Requests for Proposals and bid defenses • Assist Clinical Operations with related tasks as needed • Plan and carry out professional development

🎯 Requirements

• Bachelor’s degree in a life science or related field of study • Minimum of six (6) years’ monitoring experience • Thorough knowledge of ICH-GCP guidelines and applicable regulations • Thorough comprehension of medical terminology • Excellent organization and communication skills (both verbal and written) • Ability to travel a maximum of 70% of working hours to locations nationwide • Must maintain a valid driver’s license and be able to drive to monitor sites

🏖️ Benefits

• Equal opportunity employer • Accommodations for candidates participating in any part of the recruitment and selection process • Professional development planning and opportunities • Remote work arrangement • Less travel hours may apply for projects with remote/virtual visits