Site Management Associate

Company 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.

Hybrid role in King of Prussia, PA

• Ensures exchange of information and documentation with sites and vendors
• 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
• Coordinates preparation for and follow-up on site, TMF, and systems´ audits and inspections
• Reviews and coordinates site-specific query resolution
• Reviews and coordinates site-specific EDC completion and provides the site Monitor with regular updates on the completion status

• Exchanges information and documentation with other departments
• Supports the organization of internal team meetings including preparation of agendas and minutes
• Supports the organization of Investigator Meetings
• Maintains study-specific and corporate tracking systems
• Serves as the sites’ primary contact point
• Serves as the primary sites’ contact point for vendors, study supplies, and access management
• Ensures communication between the sites and off-site facilities

• Arranges and tracks initial and ongoing project training for site teams in all vendor-related systems
• Provides training in courier management and study supplies ordering to the site team

• Checks the TMF on a site and a country level regularly and files pending documents
• Prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists
• Provides Monitors with ISF documents to be filed in the ISF prior to each monitoring visit
• Revises and checks translations status

• Ensures proper safety information flow with the investigative sites.

• Updates CTMS with project information
• Assists Monitors in their prompt completion of all subject and site event information in CTMS
• Helps meet deadlines for site visits, reports, and visit dates in CTMS
• Tracks the resolution status of site issues and action items in CTMS

• Ensures completion of pre-study testing of local site facilities
• Tracks vendor-related supplies at the site level

College or university degree or equivalent experience demonstrating the required knowledge, skills, and abilities. Minimum 2 years of experience in the clinical research industry, corporate, or academic environment with administrative and technical skills.

• Proficiency in MS Word, Excel, Outlook, Power Point
• Knowledge of software and project systems (training provided)
• Basic typing skills in English (minimum 40 words per minute)

All your information will be kept confidential according to EEO guidelines.