ABOUT THE JOBAre you a highly motivated Clinical Trials Associate who is looking to join a remarkable company that cares about your professional growth? ProTrials is seeking a Senior Clinical Trials Associate (Sr. CTA) to join us as a critical member of our Clinical Operations team.The Sr. CTA acts as a pivotal teammate for the designated clinical study. The Sr. CTA is engaged in the planning, implementation, and completion of clinical studies and will regularly interact with the study sites, vendors, sponsors, and study team. The Sr. CTA also plays a part in accurately updating and maintaining the clinical systems. The Sr. CTA prepares, distributes, reviews, and archives clinical documentation and reports.This role is a non-exempt position.HERE IS WHAT YOU WILL DO: Set-up and maintain the electronic Trial Master File (eTMF)Assist with Quality Assurance (QA) eTMF review and general FDA readinessObtain, review, process and track study related documentsDevelop, maintain and disseminate multiple study trackersParticipate and support sponsor audit activitiesManage and track investigational product supplies for study centersAssist in preparation of materials for investigator meetings, monitor workshops, and study manualsAssist Clinical Project Manager/client in managing investigator meetingsAssist in creating and developing meeting agendas and minutes with project teams, sponsors, or vendors with minimal commentsAssist with vendor paymentsDevelop reliable relationships with client/sponsor and disseminate study related information to project teamLead, train, and provide support with the new CTA onboarding programHERE IS WHAT YOU BRING TO THE TABLE: RN, Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training2-3 years of prior experience as a Clinical Trial Associate preferredAdvanced understanding and demonstration of proficiency in CTA tasksExperience setting up and maintaining eTMFProficient with study start-up activitiesSolutions-oriented approach to problem solvingProfessional and engaging communication and interpersonal skillsRemarkable Microsoft Word and Excel competencyAbility to perform multiple tasks effectively and manage changing prioritiesAbility to read and understand regulatory documents and Standard Operating ProceduresHERE 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.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.
7 days ago