Project Coordinator I - Clinical Research

About the role

The Project Management Academy (PM Academy) trains future clinical project management leaders. Project Coordinators (PC) are the right-hand support to the Project Lead in a face-to-face, continuous learning environment. The Project Coordinator I performs the essential duties with strong guidance and support from the Project Lead, line manager, mentor and subject matter experts, and may later mentor other PM Academy PCs.

Key responsibilities

• Schedule: work with the project team to set up and maintain the project schedule, update timelines in MS Project, CTMS and other trackers, and escalate timeline risks.
• Cost: assist with timesheet vs budget reviews, vendor and sponsor contract financial tracking and reconciliation, and final project financial reconciliation.
• Scope: run the Contract vs Study Plan review, track out-of-scope work, help create change order forms and escalate out-of-scope activities to the Project Lead.
• Risk: update the Xcellerate RIIM tool, follow action items to resolution, and keep the RACT categorization complete.
• Quality: update the Project Governance Tool monthly, help identify and close quality compliance gaps, prepare for audits and investigations, and ensure timely closure of CAPAs.
• Communication: attend and set up team meetings, update the ADI log, task order matrix and project directory, and set up collaboration tools.
• Collaboration: support TMF uploading and reviews, training curriculum and delegated tasks, and escalate redaction of subject-sensitive information.
• Maintain the Lessons Learned tracker and perform other duties as assigned.

Required profile

• University or college degree (life sciences preferred) or certification in a related allied health profession; alternatively, 3+ years of relevant clinical research experience in pharma, CRO or healthcare settings.
• 0-2 years of relevant industry experience.
• Ability to develop accurate study-related documents with minimal supervision, and to communicate verbally and in writing.
• Must be able to work at a computer keyboard 6-8 hours per day and accept changes in assignments.

Required skills

• Knowledge of ICH guidelines and GCP, including international regulatory requirements, preferred.
• Computer proficiency with Microsoft Word, Excel, Project, Access and PowerPoint.