Senior Clinical Research Associate I

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

📋 Description

• Manage and oversee designated investigator sites independently from initiation through to database lock.

• Ensure adherence to Study Monitoring Plans, SOPs, GCP guidelines, and applicable regulations.

• Collaborate with Site Care Partners before site activation on essential feasibility and site selection processes, Pre-Trial Assessments (PTAs), site activation checklists, finalization of Informed Consent Documents (ICDs), and Site Initiation Visits (SIVs).

• Provide mentorship and training to Clinical Research Associates (CRAs) as assigned, fostering their development and enhancing operational capabilities.

• Act as a Subject Matter Expert (SME) regarding CRA-related processes and participate in local or regional working groups and initiatives aimed at process improvement.

• Identify, address, and manage intricate issues at investigator sites.

• Develop and implement effective CAPAs, oversee Quality Event remediations, assist with sponsor regulatory interactions/inspections, and lead the development of Audit Observation CAPAs.

• Collaborate with SCPs, Country SOMs, Clinicians, Recruitment Specialists, and Clinical Data Scientists.

• Monitor site-level Adverse Events (AEs)/Serious Adverse Events (SAEs), work closely with the Drug Safety Unit, manage investigational product oversight (including accounting, storage, and destruction), support database releases, and conduct co-monitoring activities as required.

⛳️ Requirements

• A Bachelor’s degree in Life Sciences, or a professional qualification in nursing, pharmacy, medical fields, or an equivalent discipline.

• Comprehensive understanding of clinical trial methodologies, ICH/GCP, FDA, and local regulations.

• At least 3 years of pertinent experience in clinical research site monitoring, with a preference for 2 years in Oncology.

• Prior experience in global clinical trials is mandatory.

• Proficiency in English and the native language(s) relevant to the country of employment.

• Therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.

🏝️ Benefits

• Travel Commitment: This position necessitates considerable travel (60% to 80%) within your designated area.

• A valid driver’s license and passport are mandatory.