Senior Clinical Research Associate – FSP

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Holds local accountability for the execution of studies at designated sites.

• Collaborates closely with other Clinical Research Associates (CRAs) and the Local Study Team/Local Study Associate Director (LSAD).

• Serves as the primary point of contact for the study site.

• Oversees the monitoring of study activities to guarantee proper study execution.

• Manages the preparation, initiation, monitoring, and closure of assigned sites in clinical trials.

• Ensures adherence to Client Procedural Documents, international guidelines such as ICH-GCP, and applicable local regulations.

• Participates in the selection of potential investigators.

• Provides training, support, and guidance to Investigators and site personnel regarding study-related matters.

• Verifies that site staff have completed and documented the necessary training appropriately.

• Guarantees that the sites are always inspection-ready.

• Engages in Local Study Team (LST) meetings.

• Updates the Clinical Trial Management System (CTMS) and other databases with information from study sites in accordance with required timelines.

• Prepares study drug for destruction, if necessary.

• Ensures timely resolution of data queries.

• Adheres to quality issue protocols by escalating systematic or significant quality concerns, data privacy violations, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as needed.

⛳️ Requirements

• Proficient in both written and spoken English is essential.

• Fluency in local language(s) is required.

• Strong understanding of international guidelines such as ICH-GCP, along with a foundational knowledge of GMP/GDP.

• Good familiarity with relevant local regulations.

• Solid medical knowledge and capacity to learn pertinent Client Therapeutic Areas.

• Basic understanding of the drug development process.

• Good comprehension of Clinical Study Management, including monitoring, study drug handling, and data management.

• At least 3 years of experience as an on-site Clinical Research Associate (CRA) for the Senior CRA position and a minimum of 1 year for the Clinical Research Associate role.

• Bachelor’s degree in a related field, preferably in life sciences, or an equivalent qualification.

🏝️ Benefits

• Opportunity to travel nationally and internationally as required.