Senior Site Management Associate

PSI CRO AG

. Serve as the main site contact for non-trial-participant and non-protocol-related issues, including vendors, trial supplies, and access management .

Posted 9/22/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical trial operations, including regulatory submissions, site audits, and vendor coordination. Proficient in training site teams and maintaining trial master files while ensuring compliance with industry standards.

Highest-signal resume keywords

Clinical Research ExperienceRegulatory Submission PreparationSite Audit CoordinationVendor ManagementTraining and Coaching

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementRegulatory ComplianceDocument ManagementSite ManagementData CollectionTrial Master File MaintenanceQuery ResolutionInvestigator Meeting CoordinationRecord KeepingProject Coordination

Soft Skills

CommunicationCollaborationOrganizational SkillsProblem-SolvingTeamwork

Tools & Technologies

MS WordMS ExcelMS OutlookMS PowerPointProject-Specific Systems

Industry Keywords

CROClinical ResearchSite Management AssociateTrial Supplies ManagementEthics Committee SubmissionInvestigator Site FilesTMF ChecksVendor SystemsIP-RED PackagesTraining Management

About the role

Key responsibilities & impact

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 point for other company departments on administrative site-related issues
Organize, participate in, and prepare reports of internal project team meetings
Collaborate with sites and the project team on Investigator Meetings' organization
Provide, under supervision, on-the-job coaching to Site Management Associates I & II and Clinical Operations Administrative Support staff
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 level
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 level
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, country, and regional levels
Exchange information and records with vendors

Requirements

What you’ll need

College or university degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities
Minimum 3-year experience within the clinical research industry, CRO preferred, in 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 in the future

Benefits

Comp & perks

Become a full-fledged clinical research professional with the support of a knowledgeable and professional team
Develop a variety of skills while progressing with the company and contributing to full-scale challenging projects
Remote work arrangement