Senior Clinical Research Associate

🕒 May 19

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ProTrials Research Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 1996

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

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 that have been determined to satisfy a medical need and/or offer a commercial benefit, including qualification, initiation, interim, and close-out site visits • Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion • Manage and track the preparation and return of investigational supplies at individual sites • Monitor and document investigational product dispensing, inventory, and reconciliation • Monitor and document laboratory sample storage and shipment • Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities • Review source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues • Review data queries and listings, and work with study centers to resolve data discrepancies • Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues • Maintain complete and accurate study files and review files to ensure all appropriate documentation is present • Maintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials • Serve as a resource for project team members including supporting CRA I and CRA II staff by providing solutions to resolve issues

🎯 Requirements

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

🏖️ Benefits

• Equal opportunity employer • Workplace free from discrimination and harassment. • Collaborative community committed to making a meaningful impact on global health.