Senior Clinical Research Associate

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

📋 Description

• Takes charge of all facets of study site management to ensure the protection of patient safety, the generation of high-quality data by managed sites, resulting in consistently low query levels and acceptable Quality Assurance reports.

• Offers direction at both the site and project levels to meet audit readiness standards and assists in preparing for audits and necessary follow-up actions.

• Creates, updates, monitors, and maintains study-specific trial management tools/systems and status reports.

• Oversees site startup procedures, including assessing feasibility and recruiting potential investigators, preparing EC/IRB submissions, gathering and reviewing regulatory documents, and reviewing and modifying Patient Informed Consents.

• If necessary, aids in negotiating study budgets and executing investigator contracts under the guidance of the Site Contract Management department or designee.

• Confirms that the process of obtaining informed consent has been adequately executed and documented for each subject/patient, as required or appropriate.

• Conducts all types of site visits independently, including pre-study/qualification, initiation, routine monitoring, and close-out visits, in compliance with the protocol, local laws, ICH-GCP, and Precision SOPs.

• Records activities through confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents in accordance with SOPs, Clinical Monitoring Plan/Site Management Plan, and client requirements.

• Aids in strategies for subject/patient recruitment, retention, and awareness.

• Regularly reviews the Investigator Site File (ISF) for accuracy, timeliness, and completeness.

⛳️ Requirements

• Bachelor’s degree or equivalent experience in a scientific or healthcare field.

• Minimum of 5 years as a CRA within a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies.

• Extensive experience in site management or equivalent experience in clinical research.

• Proficient in both verbal and written communication in English (Professional level).

🏝️ Benefits

• Health insurance.

• Professional development opportunities.