Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.Job ResponsibilitiesConduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, informed consent forms, and case report formsDevelop and implement tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and templatesContribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materialsManage defined components of projects or processes withh as coordinating site visits, tracking study progress, and resolving issuesEnsure accurate and timely documentation of monitoring activities and findings, including writing monitoring reports, follow-up letters, and action plansCollaborate with cross-functional teams to support clinical trial operations, including working with investigators, site staff, and other stakeholders to ensure smooth study conductQualifications:Bachelor's degree in a related field or equivalent experienceMinimum of 2-4 years of experience in clinical research monitoringStrong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirementsExcellent communication and interpersonal skillsAbility to work independently and manage multiple prioritiesProficiency in using clinical trial management systems and other relevant softwareCertifications:Certified Clinical Research Associate (CCRA) or equivalent certification preferredNecessary Skills:Attention to detail and strong analytical skillsProblem-solving abilities and critical thinkingAbility to work effectively in a team environmentStrong organizational and time management skillsProficiency in Microsoft Office SuiteGet to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.http://www.syneoshealth.comAdditional InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained hereluding the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
8 days ago