Senior Site Management Associate

🔥 1 minute ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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PSI CRO AG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1996

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

PSI CRO AG is a global contract research organization (CRO) that specializes in conducting clinical trials. The company focuses on delivering pivotal Phase 2 and 3 clinical trials across various therapeutic areas, including Inflammatory Bowel Diseases, Oncology, Hematology, Infectious Diseases, Multiple Sclerosis, and Rare Diseases. PSI utilizes a proprietary technology platform for clinical trial planning and financial tracking to ensure trials are conducted on time and within budget. The company is recognized for its expertise, quality, compatibility, and reliability, having been awarded the CRO Leadership Awards for multiple consecutive years.

📋 Description

• Serve as the main site contact for non-trial-participant and non-protocol-related issues, including vendors, trial supplies, and access management • Manage records flow with sites and off-site facilities • Prepare regulatory and ethics committee submission/notification documents and records • Coordinate payments to sites and off-site facilities • Prepare for and follow up on site audits and inspections • Review and coordinate site-specific query resolution with Monitors and sites • Review site-specific EDC completion progress and provide regular updates to the Monitor • Serve as the main contact for other company departments on administrative site-related issues • Organize, participate in, and prepare reports for internal project team meetings • Collaborate with sites and project teams on Investigator Meetings • Provide on-the-job coaching to Site Management Associates I and II and Clinical Operations Administrative Support staff under supervision • Arrange and track initial and ongoing trial training for investigator site teams in vendor-related systems • Provide training in courier management and trial supplies ordering to investigator sites • File trial records in the TMF and perform regular TMF checks at site and country levels • Participate in and follow up on TMF and systems audits • Prepare, distribute, and update Investigator Site Files and ISF checklists • Coordinate translation of trial records at site and country levels • Collect IP-REDs and compile IP-RED packages for further review • Serve as the main vendor contact for non-trial-participant-related issues, including pre-trial testing of vendor systems • Track vendor-related supplies at site and country/regional levels • Exchange information and records with vendors

🎯 Requirements

• College or university degree or an equivalent combination of education, training and experience • Minimum 3-year experience within the clinical research industry, CRO preferred, in a similar role or equivalent to Site Management Associate II • Basic proficiency in MS Word • Basic proficiency in MS Excel • Basic proficiency in MS Outlook • Basic proficiency in MS PowerPoint • Knowledge, following proper training, of applicable software and project-specific systems • Must not require a work visa for employment or continued employment now or anytime in the future

🏖️ Benefits

• Full-time employment • On-the-job coaching and professional development • Support from a knowledgeable and professional team • Opportunity to develop a variety of skills while progressing with the company • Participation in challenging full-scale projects

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