Site Management Associate (SMA)

Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information. You will focus on facilitating research projects of novel medicinal products, while taking a step further in your professional career.

Office-based role in Ra'anana, Israel

The scope of responsibilities will include:

Performs site management activities, documents and trackers management, and communication with the sites and study vendors.

Site Management and Communication

• Exchanges data, documents and other project relevant information between investigative sites, site vendors and the project team, and with other PSI departments
• Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies
• Ensures regulatory and ethics committee submissions and notifications
• Ensures proper administration of sites and vendors payments, as applicable
• Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections
• Reviews and coordinates site-specific EDC completion and provides the site Monitor with regular updates on the completion status
• Supports the organization of internal team meetings including preparation of agendas and minutes, and also of Investigator’s Meetings
• Maintains study-specific and corporate tracking systems

Document Management

• Maintains Trial Master File and performs TMF oversight at country/site level
• Prepares, distributes, and updates Investigator Site Files and ISF checklists
• Revises and checks translation status

Safety Management

• Ensures proper safety information flow with investigative sites

CTMS Management

• Updates CTMS with project information
• Supports Monitors in completion of all subject and site events information in CTMS, and meeting deadlines for site visits and visit reports