Project Coordinator I

Fortrea; Bogotá ciudad; Presencial; COP 20.088.000 - 33.480.000; Jornada completa

Descripción de la vacante

Fortrea is seeking a Project Coordinator I for the Project Management Academy to assist in scheduling, financial tracking, and project governance within a clinical research environment in Bogotá. You will work under guidance from project leads and mentors, gaining hands-on experience across study timelines, budgets, and quality processes.

You will develop study documentation, collaborate with cross-functional teams, and participate in lessons learned to improve study delivery.

Formación

• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution.
• In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
• Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs preferred.
• Computer competency with MS Word, MS Excel, MS Project, MS Access and PowerPoint.
• Ability to develop accurate study-related documents with minimal supervision.
• Ability to communicate verbally and in writing.

Responsabilidades

• Set up and maintain project schedules; update timelines in MS Project and project trackers.
• Assist with TAQ/TAR reviews and financial tracking and reconciliation.
• Maintain Contract vs Study Plan Review tracker and Change Order forms; vendor management.
• Update RIIM and RACT tools; track and resolve risks and quality issues.
• Support audits and CAPA closure; maintain monthly project governance records.

Conocimientos

Verbal & written communication

Documentation drafting

Team collaboration

Educación

Life science degree

Related allied health certification

Herramientas

MS Word

MS Excel

MS Project

MS Access

PowerPoint

Descripción del empleo

Job Overview

The mission of the Project Management Academy (PM Academy) is to identify and develop potential clinical project management leaders of the future. Within a face-to-face, continuous learning environment, Project Coordinators (PC) are the right-hand support to the Project Lead. The Project Coordinator-I performs the essential duties with a large degree of guidance and support from the Fortrea web of support that includes, but is not limited to, the Project Lead(s), Line Manager, mentor, and subject matter experts. As s/he progresses along the learning curve, the Project Coordinator I may mentor other PM Academy PCs in some areas of expertise.

Summary of Responsibilities

• TIME:
  Work with project team to set up and maintain project schedule.
  Update timelines within MS Project, CTMS, project governance tool, and other trackers.
  Escalate when timelines are at risk.
• COST:
  Work with Project Lead to assist with TAQ/TAR (timesheet vs budget) reviews;
  vendor financial tracking and reconciliation;
  sponsor contract financial tracking and reconciliation;
  and final project financial reconciliation.
• SCOPE:
  Work with Project Lead to conduct Contract vs Study Plan Review.
  Maintain tracker of out of scope (OOS) work performed.
  Assist the Project Lead to create Change Order Forms.
  Provide vendor management, escalating OOS activities to Project Lead.
• RISK:
  Update Xcellerate Risk Identification and Issue Resolution (RIIM) tool; and follow outstanding action items to resolution.
  Ensure Xcellerate Risk Assessment Categorization Tool (RACT) is complete, using Xcellerate Risk library.
  Work with Study Team to ensure Protocol Deviations are updated in Xcellerate RIIM.
• QUALITY:
  Update Project Governance Tool monthly.
  Support the study team to identify, prevent and close quality compliance gaps.
  Support the Project Lead to prepare for audits and/or investigations, including creation of story boards to document issues that may occur during the study.
  Support study team to ensure timely closure of audit/inspection CAPAs.
• TEAM COMMUNICATION:
  Facilitate study team communication and collaboration by attending and setting up team meetings; updating the ADI log; updating the Task Order Matrix; maintaining the Project Directory; setting up distribution lists, SP sites, mailboxes, and other collaboration tools; and set up / maintain project-specific trackers.
• TEAM COLLABORATION:
  Collaborate with other support functions to facilitate timely TMF uploading, TMF reviews, TMF issue resolution, systems access, project specific training curriculum, and other delegated tasks.
  Monitor for, elevate, and help to enforce redaction of subject sensitive information and identifiers in any study documentation.
• LESSONS LEARNED:
  Work with Study Team to maintain Lessons Learned tracker.
• OTHER:
  And all other duties as needed or assigned.

Qualifications (Minimum Required)

University/college degree (life science preferred), or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from appropriately accredited institution. In lieu of the above requirement, candidates with three (3) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required)

• 0-2 years of relevant industry experience
• Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs preferred.
• Computer competency with various programs (e.g., Microsoft Word, Excel, Project, Access and Power Point)
• Ability to develop accurate study related documents with minimal supervision.
• Ability to communicate verbally and in writing.

Physical Demands/Work Environment

Standard Office. Must be able to work at a computer keyboard 6-8 hours per day. Must be flexible to accept changes in work assignments, as business needs require Learn more about our EEO & Accommodations request here. Didn’t find what you were looking for? Join our Global Talent Network to stay connected with Fortrea, drive innovation and contribute to our mission of advancing life-saving therapies for patients worldwide. Follow us and stay updated about Fortrea on LinkedIn, Facebook, X, Instagram, YouTube and Glassdoor. At Fortrea, we're all about turning the \"impossible\" into \"I'm possible.\" Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.