Lead Clinical Research Associate – Contract

🔥 14 hours ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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 are performed according to SOPs, regulations, good clinical practices, key performance indicators, and study-specific requirements • Develop, review, and manage clinical plans and guidelines, including clinical monitoring plans and study timelines • Ensure compliance with monitoring intervals, review data reports and CTMS, disseminate reports to study CRAs, and resolve data discrepancies with CRAs and site staff • Create annotated visit report templates and documents and strategies related to site management and monitoring • Support team-member training and development and ensure study-specific training compliance and documentation • Guide and support CRAs, CTAs, and external CROs regarding monitoring, co-monitoring, training, and audit visits • Review site visit reports and monitoring letters according to 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 • Perform qualification, initiation, interim, and close-out visits and provide visit reports as needed • Provide direction and leadership to CRA and CTA teams, ensure timely study initiation through completion, support project management, ensure monitoring resources, and identify and address quality issues

🎯 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

• Home-based/remote work arrangement • Contract position • Equal opportunity workplace committed to freedom from discrimination and harassment