ProTrials is a women-owned, WBENC-certified Contract Research Organization (CRO) that has been a trusted partner in clinical research since 1996. Founded with a clear mission to deliver high-quality, experienced, and ethical services, we’ve supported research behind innovative treatments in the pharmaceutical, biotech, and medical device industries.Our people are the heart of everything we do. We believe great work happens when team members feel valued, supported, and empowered. At ProTrials, you’ll join a collaborative community committed to making a meaningful impact on global health. We are excited to connect with skilled individuals who share our passion for advancing clinical research with care, integrity, and excellence.ABOUT THE JOBThe Senior Clinical Research Associate (Sr. CRA) plays an integral part in the successful monitoring and management of clinical trials. Responsibilities of a Sr. CRA include ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements. Sr. CRAs may be required to travel up to 65%.HERE IS WHAT YOU WILL DO: 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 visitsManage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completionManage and track the preparation and return of investigational supplies at individual sitesMonitor and document investigational product dispensing, inventory, and reconciliationMonitor and document laboratory sample storage and shipmentMonitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalitiesReview source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issuesReview data queries and listings, and work with study centers to resolve data discrepanciesReview regulatory documentation for accuracy and completeness, and support study centers with regulatory issuesMaintain complete and accurate study files and review files to ensure all appropriate documentation is presentMaintain consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trialsServe as a resource for project team members including supporting CRA I and CRA II staff by providing solutions to resolve issuesHERE IS WHAT YOU BRING TO THE TABLE: 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 positionDetail-orientedExcellent organizational skills, strong interpersonal and communications skills, and strong problem-solving skillsFlexibility with changing prioritiesAbility to efficiently perform and prioritize multiple tasksFamiliarity with the medical and pharmaceutical industries, and related terminology and practicesExtensive knowledge of FDA regulations and their practical implementationAbility to travel, including by air or by car on short noticeProficiency in Microsoft Word, Excel, and PowerPointHERE IS WHAT WE OFFER: 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.
about 2 months ago