As a Senior CRA at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.
You will:
- Communication:
- Act as main liaison between project team, sponsor and trial sites;
- Maintain good relationships with site staff.
- Site Monitoring:
- Perform full‑cycle site visits (selection, initiation, routine, close‑out);
- Drive enrollment and timeline delivery;
- Handle AE/deviation communications, SDV, data queries and trial risk management;
- Manage investigational products and trial supplies;
- Ensure site‑level quality, data integrity and ISF/TMF compliance;
- Support audit preparation, finding resolution and CAPA activities.
- Site Management:
- Coordinate document and supply logistics among sites, labs and warehouse;
- Support site contracting & payment; provide investigator training and newsletter inputs.
- Trial Records:
- Maintain trial tracking systems;
- Assist regulatory/ethics submissions, IP‑RED collection and TMF reconciliation;
- Review translated trial records upon manager approval.
- Lead Monitoring:
- Oversee site feasibility and start‑up; review regulatory/IP‑RED documents;
- Track enrollment/timelines and implement corrective‑preventive actions;
- Review monitoring reports, drive query resolution and manage regional clinical supplies;
- Act as key contact for monitors and project leadership;
- Lead country‑level project calls, supervise audit activities, report project status, deliver investigator‑meeting presentations and mentor junior monitors.
- Other departmental assignments, as necessary.