In-House Clinical Research Associate I, Serbia, Poland, Spain

This is a fully remote position, open to applicants in Serbia, +2 more countries.

📋 Description

• Assist with site initiation activities, including coordinating feasibility questionnaires, collecting confidentiality agreements, and managing essential documents.

• Evaluate, monitor, and prepare records related to the site for the Trial Master File (TMF).

• Aid in maintaining the Investigator Site File, reconciling the TMF, and conducting quality control activities alongside field Clinical Research Associates (CRAs).

• Perform remote monitoring tasks and assist with pre-study, initiation, interim, and closeout visits under the guidance of the CRA or study leadership.

• Foster relationships with investigative sites through regular communication and ongoing support throughout the study.

• Examine electronic data capture (EDC) systems and assist in resolving queries while ensuring timely and accurate entry of study data.

• Create reports, maintain study trackers, and provide operational updates to Clinical Trial Managers and project teams.

• Support site staff management, which includes documentation for training, collecting regulatory documents, managing system access requests, and tracking delegation.

• Assist with patient prescreening, screening, recruitment activities, and tracking subject eligibility reviews.

⛳️ Requirements

• A Bachelor's degree in a medical, biological, physical, health, pharmacy, or a related scientific field is preferred.

• A combination of relevant education, training, and clinical research experience is acceptable.

• Clinical research experience as a Study Coordinator, Clinical Trial Assistant, or in another applicable clinical research role.

• A fundamental understanding of clinical research principles, processes, and Good Clinical Practice (GCP) requirements.

• Knowledge of FDA and/or EU regulations, ICH Guidelines, local regulatory requirements, and standard operating procedures for clinical research.

• Familiarity with electronic clinical systems such as EDC, eCRF, and IVRS platforms.

• Strong organizational, planning, time management, and interpersonal communication skills.

• Proficiency in Microsoft Office applications.

• Fluent in English and a native local language.

• Fluency in at least one of the following languages: French, German, Italian, or Spanish is required.

🏝️ Benefits

• A collaborative and inclusive work environment.

• Opportunities for growth and learning.

• A chance to contribute to meaningful clinical research that enhances patient care.