Clinical Research Associate Junior (CRA)

About the role

Merck Sharp & Dohme (MSD) is hiring a CRA Junior in Argentina. Working with the support of a Senior CRA, CRA Manager or CRA Manager, the CRA Junior acts as the primary site contact and site manager for assigned sites throughout all phases of a clinical research study.

Key responsibilities

• Build and maintain strong site relationships and ensure continuity across all trial phases.
• Perform site management and monitoring in line with ICH-GCP, Sponsor SOPs, local laws, the protocol and the site monitoring plan.
• Coordinate site readiness with other sponsor roles and take part in site selection and validation.
• Carry out remote and on-site monitoring, including validation, initiation, monitoring and close-out visits, and keep clear visit and non-visit contact reports.
• Collect, review and monitor regulatory documentation for study start-up, maintenance and close-out.
• Communicate with investigators and site staff on protocol conduct, recruitment, retention, protocol deviations, audits and inspections, and escalate issues through the defined escalation pathway.
• Work with country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, as well as vendors, IRBs/IECs and regulatory authorities.
• Maintain data in CTMS, eTMF and other systems, support audits and inspections, and perform co-monitoring where appropriate.

Required profile

• B.A./B.S. with a strong emphasis in science and/or biology.
• Minimum 2 years of clinical research experience; related experience may include Clinical Trial Assistant, Study Coordinator or Regulatory CTC.
• Fluent in local languages and English, with developing ability to present technical information.
• Good understanding of clinical research, ICH-GCP, country clinical research law and CRA guidelines.
• Good IT skills, including MS Office and clinical IT applications on computer, tablet and mobile.