Project Coordinator

This is a fully remote position, open to applicants in Mexico, +3 more countries.

📋 Description

• Collaborate with the project team to establish and uphold project schedules; refresh timelines in MS Project, CTMS, project governance tools, and various trackers; escalate risks related to timelines.

• Aid the Project Lead in reviewing timesheets against budget, tracking and reconciling vendor finances, managing sponsor contract finances, and performing final project financial reconciliations.

• Conduct Contract versus Study Plan Reviews alongside the Project Lead; maintain records of out-of-scope work; assist with Change Order Forms; manage vendor interactions and escalate out-of-scope activities as necessary.

• Update the Xcellerate Risk Identification and Issue Resolution (RIIM) tool and ensure action items are tracked until resolution.

• Complete the Xcellerate Risk Assessment Categorization Tool (RACT) utilizing the Xcellerate Risk library.

• Ensure that Protocol Deviations are reflected in the Xcellerate RIIM.

• Refresh the Project Governance Tool on a monthly basis.

• Assist in identifying, preventing, and resolving quality compliance gaps.

• Contribute to audit and investigation preparations, including the development of issue storyboards.

• Facilitate the timely resolution of audit/inspection CAPAs.

• Enhance communication and collaboration within the study team through meetings, ADI logs, Task Order Matrix, Project Directory, distribution lists, SP sites, mailboxes, collaboration tools, and project-specific trackers.

• Work closely with support functions on TMF uploading, TMF reviews, resolving TMF issues, managing systems access, project-specific training curricula, and delegated tasks.

• Monitor, escalate, and assist in the enforcement of redaction for subject-sensitive information and identifiers in study documentation.

• Maintain the Lessons Learned tracker in collaboration with the Study Team.

• Perform additional responsibilities as needed or assigned.

⛳️ Requirements

• 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.

• Alternatively, candidates with three (3) or more years of pertinent clinical research experience in pharmaceutical or CRO industries, or experience in a healthcare setting, will be considered.

• Fortrea may accept relevant and equivalent experience in place of educational qualifications.

• 0-2 years of applicable industry experience.

• Familiarity with ICH Guidelines and GCP, including international regulatory standards for conducting clinical development programs, is preferred.

• Proficient in various software applications (e.g., Microsoft Word, Excel, Project, Access, and PowerPoint).

• Capable of producing accurate study-related documents with minimal supervision.

• Excellent verbal and written communication skills.

• Ability to work at a computer keyboard for 6-8 hours each day.

• Must be adaptable to changes in work assignments as business needs evolve.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible work arrangements.