Site Management Associate – I

PSI CRO AG

Site Management Associate working with clinical research projects, streamlining communication and managing documentation. Involves direct contact with site personnel and regulatory submissions.

Posted 7/29/2026full-timeRemote • 🇨🇴 ColombiaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical research project support, including document management, regulatory compliance, and effective communication with site personnel and vendors. Proficient in managing clinical trial master files (TMF) and ensuring adherence to local regulations.

Highest-signal resume keywords

Clinical Research ExperienceDocument ManagementRegulatory ComplianceCommunication SkillsMS Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Master File ManagementQuery ResolutionEDC CompletionSite Event TrackingInventory Management

Soft Skills

Collaboration SkillsDynamic Team Planning

Tools & Technologies

CTMSInvestigator Site FilesVendor-Related Systems

Industry Keywords

Life Sciences DegreeCRO ExperienceLocal Regulations KnowledgeInternational Settings Experience

About the role

Key responsibilities & impact

Join our international team and be the key support to clinical research projects
Streamlining communication, maintaining systems, and managing documents & information
Being the main point of contact between site personnel and CRA involved in the project
Helping on query resolution and EDC completion
Serves as the primary sites’ contact point for vendors, study supplies, and access management
Ensure that pre-study testing of local site facilities is completed
Assists the Monitors in their prompt completion of all subject event and site event information in CTMS
Track the resolution status of site issues and action items in CTMS
Act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies
Ensures regulatory and ethics committee submissions and notifications
Coordinate preparation for and follow-up on site, TMF and systems´ audits and inspections
Manage the TMF on a site and a country level for regularly and file documents
Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists
Arrange and track initial and on-going project training for site teams in all vendor-related systems
Document Management and translations status review of the study
Ensures proper safety information flow with investigative sites.

Requirements

What you’ll need

College/University Degree in Life Sciences
Administrative work experience, preferably in international settings
Prior experience working as CTA for CROs
Prior experience working in Clinical Research
Local regulations knowledge
Full working proficiency in English
Proficiency in MS Office applications
Ability to plan and work in a dynamic team environment
Communication and collaboration skills.

Benefits

Comp & perks

Remote work arrangements