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. The role is based in Portugal, Spain, France, or the UK.

Role Overview

The Senior Clinical Research Associate (SCRA) will manage one existing site and set up and monitor three new sites for one study. The position is responsible for clinical monitoring of assigned protocols and investigational sites, ensuring that studies are conducted and documented in accordance with the study protocol, standard operating procedures, Good Clinical Practice (GCP), and other applicable regulatory requirements.

Responsibilities

• Conduct all types of monitoring, including co‑monitoring visits and associated monitoring activities for assigned clinical sites both in person and remotely.
• Perform site initiation, interim, and close‑out monitoring visits and complete monitoring reports within required SOP and local regulatory parameters.
• Conduct study start‑up activities such as site identification, feasibility activities, collection and preparation of site essential documents, Ethics Committee submissions, and other site set‑up activities.
• Develop and maintain study‑specific documentation related to monitoring activities, including monitoring trackers, clinical monitoring guidelines, clinical monitoring plan, source document templates, site tools, and worksheets.
• Train site personnel on protocol requirements, proper source documentation procedures, and case report completion requirements.
• Review source documentation and case report forms for accuracy, completeness, and data integrity, identifying and resolving ongoing data issues.
• Manage, prepare, send, track, and return investigational supplies, documenting dispensing, inventory, and reconciliation.
• Monitor clinical trials and sites by reviewing and reporting site enrollment, termination updates, protocol deviations, serious adverse events, laboratory abnormalities, and other activities necessary for proper trial conduct.
• Review and oversee regulatory documentation for accuracy and completeness, supporting sites with regulatory concerns.
• Maintain communication with clinical sites, investigators, site personnel, client personnel, and cross‑functional team members to address study needs related to monitoring and site management.
• Participate in meetings and conference calls with internal project teams, sponsor teams, and external partners.
• Perform other duties as assigned.

Necessary Skills And Abilities

• Excellent verbal, written communication, interpersonal, and presentation skills.
• Proficient computer skills, including Microsoft Office applications (Outlook, Word, Excel, PowerPoint) for data presentation and reporting.
• Experience with Electronic Data Capture (EDC), CTMS, IVRS, and eTMF systems.
• Knowledge of applicable local laws, regulatory requirements, ICH Guidelines, and GCP governing clinical trials.
• Ability to prioritize tasks, plan proactively, and accomplish goals with minimal supervision.
• Problem‑solving skills and the ability to provide solutions when obstacles arise, including training to achieve project goals.
• Strong organizational skills, attention to detail, and workload prioritization.

Educational Requirements

• Bachelor’s degree or equivalent combination of education and experience.

Experience Requirements

• More than 5 years of experience as a Clinical Research Associate.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, or disability status.