Senior Clinical Research Associate

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, medical device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. Responsibilities Conduct all types of monitoring, and co‑monitoring visits and associated monitoring activities for assigned clinical sites both in person and remotely, including evaluation, site initiation, interim and close‑out monitoring visits. Write and complete monitoring reports within required SOP and local regulatory parameters. Perform study start‑up activities in Ex‑US locations, including site identification and feasibility, collection and preparation of site essential documents, Ethics Committee submissions, and other site set‑up activities. Support the development of study‑specific documentation related to monitoring activities, such as monitoring trackers, clinical monitoring guidelines, clinical monitoring plans, source document templates, site tools and worksheets. Manage site personnel and provide training on protocol requirements, proper source documentation procedures, compliance, and case report completion requirements. Review source documents and case report forms for accuracy, completeness, and integrity, and identify and resolve ongoing data issues. Manage, prepare, send, track, and return investigational supplies as assigned, including monitoring and documenting dispensing, inventory, and reconciliation. Monitor assigned clinical trials and sites by reviewing and reporting on site enrollment, termination updates, monitoring visits, protocol deviations, serious adverse events, laboratory abnormalities, and other activities that contribute to the proper conduct of the clinical trial per protocol and regulatory requirements. Review and oversee regulatory documentation for accuracy and completeness, and support assigned clinical sites with any regulatory concerns as appropriate. Communicate with assigned clinical sites, investigators, site personnel, client personnel, and other cross‑functional team members involved in the assigned clinical trials to address any study needs related to monitoring and site management activities. Participate in meetings and conference calls with internal project teams, sponsor teams, and external partners working on execution of the assigned clinical trial. Perform other duties as assigned. Skills and Abilities Excellent verbal, written communication, interpersonal, and presentation skills. Proficient computer skills with experience in Microsoft Office (Outlook, Word, Excel, PowerPoint) for preparing charts, tables, forms, reports, and presentations. Experience with electronic data capture (EDC), clinical trial management systems (CTMS), interactive voice response systems (IVRS), and electronic trial master file (eTMF). Knowledge of applicable local law, local regulatory requirements and regulations, ICH guidelines, and GCPs governing the conduct of clinical trials. Ability to prioritize tasks, plan proactively, and accomplish goals using well‑defined instructions and procedures with minimal supervision. Ability to solve problems and provide solutions when obstacles are identified, and to train others to achieve project goals. General understanding of routine project goals from an organizational perspective. Strong organizational skills and attention to detail. Education Bachelor's degree or equivalent combination of education and experience. Experience More than 5 years of experience as a Clinical Research Associate. EEO Statement We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. #J-18808-Ljbffr PPG US ProPharma Group, LLC