Clinical Research Associate II (Burzaco)

Parexel FSP is looking for CRAs to join our team in Argentina. We are looking for candidates with +1 year of monitoring experience, based in Buenos Aires.

The Clinical Research Associate will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan and will be performed virtually for the majority of activities to supplement on‑site visit requirements. The Clinical Research Associate will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready.

Key Accountabilities Maintenance (from initiation through close out)
- Act as PAREXEL’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem‑solving to address and resolve site issues.
- Build relationships with investigators and site staff.
- Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
- Evaluate if on‑site staff assignment is still accurate and determine and implement corrective actions & follow‑up, if necessary / relevant.
- Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
- Address/evaluate/resolve issues pending from the previous visit, if any.
- Follow‑up on and respond to appropriate site related questions.
- Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow‑up action.
- Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
- Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable. Postúlate en Kit Empleo: kitempleo.com.ar/empleo/qaych