Lead Clinical Research Associate

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $135k - $159k / 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

• Provide study oversight as the primary liaison between CRAs, internal staff, study site staff including investigators, coordinators, client personnel, and external vendors involved in all stages of the study • Ensure clinical monitoring activities of the study CRA team(s) are performed in accordance with applicable Standard Operating Procedures (SOP), regulations, good clinical practices, key performance indicators, and study-specific requirements • Develop, review, and manage clinical plans and guidelines, including the clinical monitoring plan and study timelines; ensure compliance with monitoring intervals according to project requirements, review data reports, CTMS, disseminate listings/reports to study CRAs, and work with CRAs and site staff to resolve data discrepancies • Create annotated visit report templates and other documents and strategies related to site management and monitoring • Support training and development of team members, ensure compliance with study specific training requirements, and ensure training is appropriately documented • Guide and support CRAs, CTAs, and external contract research organizations regarding monitoring, co-monitoring, training, and audit visits; review site visit reports and monitoring letters in accordance with study and SOP requirements • Manage oversight of the Trial Master File (TMF)/eTMF and assist with filing and quality control • Track serious adverse events, protocol deviations, enrollment, ICFs, study contacts, investigational supplies, and investigational product for assigned study and review with appropriate members of the study team • Perform qualification, initiation, interim, and close out visits and provide visit reports as per monitoring guidelines as needed

🎯 Requirements

• RN, Bachelor, or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education, and training • Previous CRA experience preferred • Proven excellence in professional skills including communication, organization, prioritization, presentation, discretion, and accuracy • Solutions-oriented approach to problem solving • Familiarity with medical and pharmaceutical industry, and related terminology and practices • Extensive knowledge of Food and Drug Administration regulations and their practical implementation • Willingness to travel and perform remote and on-site monitoring, if needed • Proficiency in Microsoft Word, Excel, and PowerPoint

🏖️ Benefits

• Work-life balance supporting meaningful workloads alongside everyday life • Collaborative community focused on building a healthier world