Lead Clinical Research Associate

🔥 15 hours ago

🇺🇸 United States – Remote

💵 $135k - $159k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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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, investigators, coordinators, client personnel, and external vendors • Ensure clinical monitoring activities comply with SOPs, regulations, good clinical practices, key performance indicators, and study-specific requirements • Develop, review, and manage clinical plans, monitoring guidelines, study timelines, data reports, CTMS, and discrepancy resolution • Create annotated visit report templates and site management and monitoring documents and strategies • Support team-member training and development and ensure 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 • Manage oversight of the 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 accurate and timely study initiation, enrollment, conduct, and completion • Identify clinical monitoring quality issues and establish corrective action plans with the study team

🎯 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 communication, organization, prioritization, presentation, discretion, and accuracy • Solutions-oriented approach to problem solving • Familiarity with the medical and pharmaceutical industry, 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

• Full medical, dental, and vision insurance options for you and your family • Flexible PTO • 401(k) plan with a company match • Support and opportunities for professional growth and career development • Collaborative community and supportive coworkers