Project Coordinator

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

📋 Description

• Collaborate with the project team to establish and uphold project schedules.

• Revise timelines using MS Project, CTMS, project governance tools, and other tracking systems; identify and escalate timeline risks.

• Aid in reviewing timesheets against budgets, tracking and reconciling vendor finances, reconciling sponsor contract finances, and final project financial assessments.

• Perform Contract versus Study Plan evaluations and manage out-of-scope work trackers.

• Assist with Change Order Forms and oversee vendor management.

• Update tools for risk identification, issue resolution, and risk assessment; monitor action items until resolution.

• Ensure that protocol deviations are recorded in the RIIM tool.

• Monthly update of the Project Governance Tool and support in identifying, preventing, and closing quality compliance gaps.

• Assist with audits and investigations, including preparing storyboards and ensuring prompt resolution of audit/inspection CAPAs.

• Facilitate communication within the study team through meetings, logs, matrices, directories, distribution lists, SharePoint sites, mailboxes, and project trackers.

• Collaborate with support functions on TMF uploads and reviews, issue resolution, system access, training curriculum, and delegated tasks.

• Monitor, escalate, and enforce the redaction of sensitive subject information and identifiers.

• Maintain the Lessons Learned tracker.

• Carry out other assigned duties.

⛳️ Requirements

• A university or college degree (preferably in life sciences), or a certification in a related allied health profession (e.g., nursing, medical or laboratory technology) from an accredited institution.

• Candidates with three (3) or more years of pertinent clinical research experience in the pharmaceutical or CRO industries, or experience in a healthcare environment, will also be considered in lieu of the above requirement.

• Relevant and equivalent experience may substitute for educational qualifications.

• 0-2 years of applicable industry experience.

• Preferred knowledge of ICH Guidelines and GCP, including international regulatory requirements for clinical development programs.

• Proficiency in Microsoft Word, Excel, Project, Access, and PowerPoint.

• Capability to produce accurate study-related documentation with minimal oversight.

• Strong verbal and written communication skills.

• Must be able to operate a computer keyboard for 6-8 hours each day.

• Flexibility to adapt to changes in work assignments as business needs evolve.

🏝️ Benefits

• Comprehensive health and wellness plans.

• Opportunities for professional development and training.

• A collaborative and supportive work environment.