Clinical Research Associate
ProTrials Research Inc.
Senior Clinical Research Associate
ProTrials Research Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteSalary
💰 $130,000 - $155,000 per year
Job Level
Senior
About the role
- 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
- Your wellness matters to us – that’s why we provide full medical, dental, and vision insurance options for you and your family.
- We know life doesn’t pause for work – we provide flexible PTO so you can take care of what matters, both personally and professionally.
- You invest in your future – and so do we. Our 401(k) plan includes a company match to help you reach your financial goals.
- At ProTrials, we are committed to your growth. Whether you’re looking to expand your skills or take the next step in your career, we provide the support and opportunities you need to keep moving forward.
- We have the best coworkers, if we do say so ourselves.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical study monitoringdata accuracy reviewsource documentationcase report form completionregulatory documentation reviewinvestigational product managementlaboratory sample managementprotocol deviation managementdata discrepancy resolutioninventory reconciliation
Soft skills
detail-orientedorganizational skillsinterpersonal skillscommunication skillsproblem-solving skillsflexibilitytask prioritizationteam supportresourcefulnessadaptability
Certifications
RNBachelor's degree in biological sciencesadvanced degree in biological sciences
