Remote Assistant Clinical Research Associate

Convoy Finance; Quilmes; Vor Ort; ARS 1.000.000 - 1.400.000; Vollzeit

Zusammenfassung

Thermo Fisher Scientific in Buenos Aires seeks an Assistant Clinical Research Associate to support site readiness, monitoring and regulatory compliance across trials globally. You will collaborate with the CRA and Clinical Lead, perform pre-study assessments, assist with site management, remote monitoring, and document control while adhering to SOPs and regulatory guidelines.

Excellent communication and organizational skills required.

Qualifikationen

• Bachelor's degree in a life science discipline or related field or a Registered Nursing certification or equivalent.
• 0–2 years of relevant experience.
• Equivalency may be considered sufficient for the role.

Aufgaben

• Complete study and site management activities as defined in task matrix.
• Complete and document study-specific training.
• Orient and train on any study-specific systems.
• Provide in-house support during pre-study assessments and waivers.
• Support site ICF customization with site contact details.
• Perform remote review of EMR/EHR checklists and support data collection.
• Verify document collection and RCR submission status; update site EDL and verify site information.
• Review patient materials and translations as directed.
• Support vendor qualification processes where applicable.
• Ensure system access for site staff during pre-activation and study.
• Follow up on site staff training as applicable.
• Coordinate and support logistics for IM attendance.
• Maintain vendor trackers as directed.
• Coordinate study/site supply management during pre-activation and subsequent course of the study.
• Support Essential Document collection and updating in systems.
• Follow up on missing vendor data like ECGs, labs, and e-diaries.
• Assist with remote review of centralized monitoring tools.
• Support Site payments processes and reconciliations; follow up on invoices.
• Perform reconciliation tasks on trials including CRF and queries.
• Drive action for missing/incomplete/expired documents.
• May perform other site management tasks as directed.
• May perform a role profile for FSP opportunities per Client requests.
• Maintain and complete administrative tasks such as expense reports and timesheets.

Kenntnisse

ICH GCP knowledge

Communication skills

MS Office

English proficiency

Organizational skills

Teamwork

Ausbildung

Bachelor's degree in life science

Registered Nursing certification

Tools

CTMS

Jobbeschreibung

Thermo Fisher Scientific in Buenos Aires seeks an Assistant Clinical Research Associate to support site readiness, monitoring and regulatory compliance across trials globally. You will collaborate with the CRA and Clinical Lead, perform pre-study assessments, assist with site management, remote monitoring, and document control while adhering to SOPs and regulatory guidelines.

Excellent communication and organizational skills required.