Senior Clinical Research Associate

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $130k - $155k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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ProTrials Research Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1996

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

ProTrials Research Inc. is a clinical research organization (CRO) headquartered in the United States, offering a wide range of services to the pharmaceutical, biotechnology, and medical device industries. The company provides quality-driven site management, clinical monitoring, project management, data management, and supportive clinical development services. With a focus on therapeutic areas such as oncology, ophthalmology, central nervous system, infectious diseases, women's health, and medical devices & diagnostics, ProTrials is dedicated to delivering high-quality clinical research. Their services include project management, clinical operations, quality assurance, medical and regulatory support, and they also act as a functional service provider, emphasizing virtual trials and remote monitoring capabilities.

📋 Description

• Monitor clinical studies of investigational and approved products through qualification, initiation, interim, and close-out site visits • Manage and train site personnel on therapeutic areas, protocol requirements, source documentation, and case report form completion • Manage and track investigational supplies at individual sites • Monitor and document investigational product dispensing, inventory, and reconciliation • Monitor and document laboratory sample storage and shipment • Review and report site enrollment, termination updates, monitoring visits, protocol deviations, serious adverse events, and laboratory abnormalities • Review source data and case report forms for accuracy, completeness, and data integrity; identify and resolve data issues • Review data queries and listings and resolve discrepancies with study centers • Review regulatory documentation and support study centers with regulatory issues • Maintain complete and accurate study files • Maintain timely contact with study centers, investigators, coordinators, client personnel, and other clinical-trial stakeholders • Support CRA I and CRA II staff by providing solutions to resolve issues • Ensure clinical trials comply with protocols, SOPs, ICH GCP, and applicable regulatory requirements • Travel up to 65% as required

🎯 Requirements

• RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training • Previous CRA experience demonstrating career growth in the CRA position • Detail-oriented • Excellent organizational, interpersonal, communication, and problem-solving skills • Flexibility with changing priorities • Ability to efficiently perform and prioritize multiple tasks • Familiarity with the medical and pharmaceutical industries, terminology, and practices • Extensive knowledge of FDA regulations and their practical implementation • Ability to travel, including by air or car on short notice • Proficiency in Microsoft Word, Excel, and PowerPoint

🏖️ Benefits

• Full medical, dental, and vision insurance options for you and your family • Flexible PTO • 401(k) plan with company match • Professional growth support and career development opportunities • Collaborative coworker environment