Senior Site Management Associate

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

📋 Description

• Act as the primary site liaison for issues unrelated to trial participants or protocols, including vendor management, trial supplies, and access control.

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

• Prepare documentation and records for regulatory and ethics committee submission/notification.

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

• Prepare for and conduct follow-ups on site audits and inspections.

• Review and facilitate 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.

• Serve as the primary contact for other departments regarding administrative site-related matters.

• Organize, participate in, and compile reports from internal project team meetings.

• Collaborate with sites and the project team to organize Investigator Meetings.

• Provide on-the-job coaching to Site Management Associates I & II and Clinical Operations Administrative Support staff under supervision.

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

• Deliver training on courier management and trial supplies ordering to investigator sites.

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

• Participate in and oversee follow-up actions for TMF and systems audits.

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

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

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

• Act as the primary vendor contact for issues not related to trial participants, including pre-trial testing of vendor systems.

• Monitor vendor-related supplies across site, country, and regional levels.

• Share information and documents with vendors.

⛳️ Requirements

• A college or university degree, or an equivalent combination of education, training, and experience that provides the necessary knowledge, skills, and abilities.

• At least 3 years of experience in the clinical research field, preferably in a CRO, in a role similar to 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 of applicable software and project-specific systems, following appropriate training.

• Must not require a work visa for current or future employment.

🏝️ Benefits

• Become a fully-fledged clinical research professional with the backing of an experienced and professional team.

• Enhance a variety of skills while advancing within the company and contributing to comprehensive and challenging projects.

• Enjoy a remote work arrangement.