Senior Site Management Associate

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the primary site contact for issues unrelated to trial participants and protocols, including vendor interactions, trial supply management, and access oversight.

• Oversee the flow of records between sites and off-site facilities.

• Prepare documents and records for regulatory and ethics committee submissions/notifications.

• Coordinate financial transactions with sites and off-site facilities.

• Prepare for site audits and inspections, and ensure proper follow-up.

• Review and coordinate the resolution of site-specific queries in collaboration with Monitors and sites.

• Monitor site-specific EDC completion progress and provide regular updates to the Monitor.

• Act as the key liaison for other company departments on administrative matters related to sites.

• Organize, participate in, and generate reports for internal project team meetings.

• Collaborate with sites and project teams regarding Investigator Meetings.

• Provide on-the-job training to Site Management Associates I and II, as well as Clinical Operations Administrative Support staff under supervision.

• Arrange and monitor both initial and ongoing trial training for investigator site teams in vendor-related systems.

• Offer training in courier management and trial supplies ordering to investigator sites.

• File trial records in the TMF and conduct regular TMF audits at both site and country levels.

• Engage in and follow up on TMF and systems audits.

• Prepare, distribute, and update Investigator Site Files and ISF checklists.

• Coordinate the translation of trial records at both site and country levels.

• Collect IP-REDs and compile IP-RED packages for further assessment.

• Serve as the main point of contact for vendors regarding non-trial-participant-related issues, including pre-trial testing of vendor systems.

• Monitor vendor-related supplies at site and country/regional levels.

• Facilitate the exchange of information and records with vendors.

⛳️ Requirements

• A college or university degree, or an equivalent combination of education, training, and experience.

• At least 3 years of experience in the clinical research industry, preferably within a CRO, in a comparable 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.

• Familiarity, following appropriate training, with applicable software and project-specific systems.

• Must not require a work visa for employment or continued employment now or at any future time.

🏝️ Benefits

• Full-time employment.

• On-the-job coaching and opportunities for professional development.

• Support from a knowledgeable and professional team.

• Opportunity to enhance a variety of skills while advancing within the company.

• Involvement in challenging full-scale projects.