PSI CRO

Global CRO delivering on-time patient enrollment

Senior Site Management Associate

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timeRemote in USANo salary listed

About the Job

Requirements

A college or university degree, or an equivalent combination of education, training, and experience that demonstrates the required knowledge, skills, and abilities.
At least 3 years of experience in the clinical research industry; CRO experience is preferred, in a similar role or equivalent to Site Management Associate II.
Basic proficiency in Microsoft Word, Microsoft Excel, Microsoft Outlook, and Microsoft PowerPoint.
Knowledge of applicable software and project-specific systems following proper training.

Responsibilities

Serve as the main site contact for all non-trial-participant-related 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 and 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 electronic data capture completion progress and provide the Monitor with regular updates.
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 to organize Investigator Meetings.
Provide on-the-job coaching of 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.
Train investigator sites in courier management and trial supplies ordering.
File trial records in the Trial Master File and perform regular Trial Master File checks at site and country levels.
Participate in and follow up on Trial Master File and systems audits.
Prepare, distribute, and update Investigator Site Files and 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 all 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.

Desired Qualifications

CRO experience is preferred.

Job Description

The scope of responsibilities will include:

Main site contact for all non-trial-participant related and non-protocol
related issues, including vendors, trial supplies and access management
Manages records flow with sites and off-site facilities
Prepares regulatory and ethics committee submission/ notification
documents and records
Coordinates payments to sites and off-site facilities
Prepares for and follows up on site audits and inspections
Reviews and coordinates site-specific query resolution with Monitors and
sites
Reviews site-specific EDC completion progress and provides the Monitor
with regular updates
Serves as the main contact point for other company departments in
administrative site-related issues
Organizes, participates in, and prepares reports of internal project team
meetings
Collaborates with sites and project team on Investigator Meetings'
organization
Under supervision, provides on-the-job coaching of Site Management
Associates I & II and Clinical Operations Administrative Support staff
Arranges and tracks initial and ongoing trial training for investigator site
teams in all vendor-related systems
Provides training in courier management and trial supplies ordering to the
investigator sites
Files trial records in the TMF and performs regular TMF checks on a site and country level
Participates in and follows up on TMF and systems audits
Prepares, distributes, and updates Investigator Site Files (ISF) and ISF
checklists
Coordinates the translation process for trial records on a site and country
level
Collects IP-REDs and compiles IP-RED packages for further review
Main vendor contact for all non-trial participant related issues, including pre-trial testing of vendor systems
Tracks vendor-related supplies on a site, country/regional level
Exchanges information and records with vendors

Qualifications

College or university degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient.
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 Power Point.
Knowledge (following proper training) of applicable software and project specific systems.

Additional Information

Become a full-fledged clinical research professional with the support of a knowledgeable and professional team. You will develop a variety of skills while progressing with the company and contributing to our full-scale challenging projects.

For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

About the Company

PSI CRO

Global CRO delivering on-time patient enrollment

PSI CRO is a global contract research organization that handles clinical trials for multiple therapeutic areas, with a focus on enrolling patients on schedule and delivering studies on time. Its services span feasibility assessments, trial planning, site selection, patient recruitment, and multi-continent trial execution across 50+ countries, backed by medical doctor resources dedicated to accurate timeline predictions. Unlike many CROs, PSI emphasizes predictable enrollment and on-time project delivery, aiming for high client satisfaction and repeat business through a pragmatic, no-nonsense approach. The company’s goal is to be regarded as the best CRO in the world by both clients and employees, achieved through reliable timelines, strong execution, and low staff turnover.

Company size: 1,001-5,000
Company stage: Not listed
Total funding: Not listed
Headquarters: Switzerland
Founded: 1995

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