PSI CRO
Healthcare
ProjectCoordinationAssociate
“Project Coordination Associate at PSI CRO. Skills: Trial administrative support, Site management, Communication with stakeholders. Supervise trial administrative support. Coordinate trial administrative support”
Industry & Context.
What They're Looking For.
Must Have
Minimum four years of CRO and/or relevant clinical research experience, Must be in a commutable distance to the office in King of Prussia, PA, Proficient in using Microsoft Office tools
What You'll Do.
Supervise trial administrative support
Coordinate trial administrative support
Coordinate site management
Communicate with investigator sites
Communicate with sponsor
Communicate with trial vendors
Communicate with project team
Ensure trial planning
Ensure trial implementation
Ensure trial management
Ensure compliance with industry regulations
Ensure compliance with ICH-GCP
Ensure compliance with essential trial records
Ensure compliance with applicable controlled documents
Ensure consistency of Clinical Operations processes
Organize exchange of trial-specific information
Organize exchange of trial records
Participate in regulatory submissions
Follow up on regulatory submissions
Participate in ethics committee submissions
Follow up on ethics committee submissions
Track financial tasks
Track contractual tasks
Supervise preparation for site audits
Supervise follow-up on site audits
Supervise preparation for site inspections
Supervise follow-up on site inspections
Organize project meetings
Participate in project meetings
Prepare reports of project meetings
Organize Investigator Meetings
Attend Investigator Meetings
Follow up on Investigator Meetings
Conduct on-the-job coaching
Coordinate compliance of trial-specific trainings
Monitor compliance of trial-specific trainings
Supervise site handovers
Supervise trial handovers
Maintain TMF quality checks
Oversee TMF quality checks
Prepare for system audits
Follow up on system audits
Prepare for system inspections
Follow up on system inspections
Supervise preparation of ISFs
Supervise preparation of ISF checklists
Supervise translation process for trial records
Maintain trial-specific tracking management systems
Maintain corporate tracking management systems
Review trial-specific tracking management systems
Review corporate tracking management systems
Supervise timely update of tracking systems
Coordinate clinical supplies order
Coordinate clinical supplies receipt
Coordinate clinical supplies inventory
Coordinate clinical supplies distribution
Coordinate clinical supplies return/recall
Coordinate clinical supplies reconciliation
Maintain accurate records of clinical supplies
Initiate trial-specific IP-REDs review process
Supervise trial-specific IP-REDs review process
Supervise performance of Site Management Associates
Perform other assigned trial coordination tasks
How You'll Work.
Team & Collaboration
Communication with investigator sites; Communication with sponsor; Communication with trial vendors; Communication with project team; Work in a team setting; Work independently
Communication Scope
Communication with investigator sites; Communication with sponsor; Communication with trial vendors; Communication with project team; Presentation skills
Process & Methodology
Project plans, Trial coordination
Applying for this Project Coordination Associate role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on SmartRecruiters
- SmartRecruiters often includes a video screening step — check camera and mic permissions.
- Link your GitHub or portfolio directly in the profile section for technical roles.
- Applications may be reviewed by AI scoring before reaching a recruiter — use keywords from the job description.
ANONYMOUS · UNFILTERED
What do employees actually say about PSI CRO?
Real rants from real employees. Read before you apply.