Freelance SCRA - 0.4 FTE - Portuguese Speaking

We have an immediate need for an SCRA to join us on a Freelance basis to support monitoring in Portugal.Based in Portugal, Spain, France or the UK.The SCRA will manage one existing site and set up and monitor three new sites for one study.The Senior Clinical Research Associate position is responsible for clinical monitoring for assigned protocols and investigational sites. The role is responsible for ensuring that studies are conducted and documented in accordance with the study protocol, standard operating procedures, Good Clinical Practices (GCP) and other applicable regulatory requirements. Responsible for conduct of all types of monitoring, and co-monitoring visits and associated monitoring activities for assigned clinical sites both in person, and remote. This includes evaluation, site initiation, interim and close out monitoring visits. Responsible for monitoring report writing and completion within required SOP and local regulatory parameters.Support development of study specific documentation related to monitoring activities as assigned. This includes but is not limited to monitoring trackers, clinical monitoring guidelines, clinical monitoring plan, source document templates, site tools, and worksheets, etc. Responsible for site personnel management and training on the protocol requirements, proper source documentation procedures compliance, and case report completion requirements. Monitor assigned clinical trials and clinical sites by reviewing and reporting site enrollment, and termination updates, monitoring visits, protocol deviations, serious adverse events, laboratory abnormalities and any other activity at the site that contributes to proper conduct of the clinical trial per protocol, and regulatory requirements. Other duties as assigned. Necessary Skills and Abilities: Excellent verbal, written communication skills and interpersonal and presentation skills are required.Excellent computer skills with experience using Microsoft Office (Outlook, Word, Excel, and Power Point) applications to prepare charts, tables, forms, reports, and presentations required. Electronic data capture (EDC), CTMS, IVRS, and eTMF experience required. Knowledge of applicable local law, local regulatory requirements and regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.Must be able to prioritize tasks, plan proactively, and accomplish goals using well-defined instructions and procedures with minimal supervision.Strong organizational skills and attention to details required. Ability to prioritize and plan workload is essential. Educational Requirements: Bachelor's degree or equivalent combination of education and experience. Experience Requirements: > 5 years of experience as a Clinical Research Associate.ProPharma will never ask you for any bank account information, financial information, or another form of payment to be considered for a role. Additionally, the ProPharma talent acquisition team will only use their work email addresses (). If you receive recruiting communications from anyone with a or any other email account, it's likely a fraud.