PSI CRO
Healthcare
ProjectCoordinationAssociate
Neural analysis suggests this role is
optimal for mid candidates.
“Project Coordination Associate at PSI CRO. Skills: Trial coordination, Site management, Regulatory compliance. Supervise and coordinate trial administrative support. Manage trial records”
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 and coordinate trial administrative support
Communicate with investigator sites
Communicate with sponsor
Communicate with trial vendors
Communicate with project team
Ensure planning of trials
Ensure implementation of trials
Ensure management of trials
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 distribution of ISFs
Supervise update of ISFs
Supervise preparation of ISF checklists
Supervise distribution of ISF checklists
Supervise update 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 management systems
Coordinate clinical supplies order
Coordinate clinical supplies receipt
Coordinate clinical supplies inventory
Coordinate clinical supplies storage
Coordinate clinical supplies distribution
Coordinate clinical supplies return
Coordinate clinical supplies 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
Communication Scope
Presentation skills
Process & Methodology
Trial planning, Trial implementation, Trial management, Project plans
Full Job Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them. The Project Coordination Associate supervises and coordinates trial administrative support, management of trial records, site management, and communication with the investigator sites, the sponsor, trial vendors, and members of the project team. This function operates at a regional or global trial level. Responsibilities Include: * Ensures planning, implementation, and management of trials in compliance with industry regulations, ICH-GCP, essential trial records and applicable controlled documents (e.g., PSI QSDs or Sponsor QMS documents) * Ensures consistency of Clinical Operations processes in the assigned trials across the trial regions * Organizes the exchange of trial-specific information and records with sites, sponsors, and vendors * Participates in and follows up on regulatory and ethics committee submissions and notifications * Tracks the financial and contractual tasks within the project team * Supervises the preparation for and follow-up on site audits and inspections * Organizes, participates in and prepares reports of project meetings * Organizes, attends, and follows up on Investigator Meetings * Conducts on-the-job coaching of Site Management Associates and Clinical Operations Administrative Support staff * Coordinates and monitors compliance of trial-specific trainings of the project team * Supervises site and trial handovers between Site Management Associates Project Coordination Associate * Maintains and oversees the regular TMF quality checks for completeness and accuracy * Prepares for and follows up on system audits and inspections * Supervises the preparation, distribution, and update of ISFs and
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