Freelance Senior Clinical Research Associate at TFS HealthScience

Pharmaceutical Technicians and Assistants

Freelance Senior Clinical Research Associate

TFS HealthScience

Amsterdam, North Holland, Netherlands

Freelance

Full-time

Remote

Expert

Starts as soon as possible

posted 5 days ago

Vacancy Summary

Join TFS HealthScience as a Freelance Senior Clinical Research Associate in our Ophthalmology team. You will conduct site monitoring visits and ensure compliance with clinical protocols while working with innovative professionals dedicated to improving patient outcomes.

Required skills

Regulatory Requirements

Audit

Compliance

Verification

Innovation

analyses

Data Quality

Clinical Development

Clinical Research

Ownership

Growth

CRO

monitoring

Oncology

Teams

Driving

Nursing

service

Quality Oversight

Dutch

English

Google Cloud Platform (GCP)

Compensation

Employee Engagement

TFS

Database

Support

FSP

Therapy

Pharmacy

Flexibility

Qualification

Clinical Trial Regulations

Inspection Readiness

CRA

execution

Regulatory Documentation

Make

Study Protocols

Management

Delivery

Provider

Bachelor's Degree

ICH

Site Initiation

CDS

Reports

Culture

Aligning

Sustainability

JOIN

Benefits

Clinical Protocols

deviations

Operational Oversight

English level

Fluent

Languages

Dutch

English

TFS HealthScience is a prominent global mid-size Contract Research Organization (CRO) that collaborates with biotechnology and pharmaceutical companies throughout their clinical development journey. Our expertise encompasses full service capabilities, resourcing, and Functional Service Provider (FSP) solutions. As a Freelance Senior Clinical Research Associate, you will be an integral part of our CDS Ophthalmology team, working with passionate professionals to help our clients achieve their objectives.

The Role

In this role, you will conduct site monitoring visits and oversee study-related activities to ensure adherence to clinical protocols, ICH-GCP guidelines, and relevant regulatory requirements. You will support issue identification and resolution, foster effective relationships with investigative site personnel, and provide operational oversight to ensure successful study execution and data quality throughout the trial duration.

Responsibilities

Take ownership of investigative sites from activation to study close-out.
Conduct Site Qualification Visits (SQV), Site Initiation Visits (SIV), routine Monitoring Visits (MV), Quality Oversight Visits, co-monitoring visits, and Close-Out Visits (COV).
Ensure compliance with study protocols, ICH-GCP guidelines, and applicable regulations.
Verify source documentation, informed consent processes, investigational product accountability, and essential regulatory documentation.
Identify, document, communicate, and escalate protocol deviations, compliance concerns, and study risks.
Ensure study milestones are met according to timelines, including site activation, patient recruitment, database analyses, and study close-out.
Build and maintain strong relationships with investigators and site personnel to support successful study delivery.
Ensure site staff are adequately trained and qualified throughout the study.
Prepare accurate and timely monitoring reports, follow-up letters, and study documentation.
Collaborate closely with cross-functional teams, study management, and sponsor stakeholders.
Support audit and inspection readiness activities as required.

About TFS HealthScience

TFS HealthScience

TFS HealthScience is a full-service, global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance innovative treatments and improve patient outcomes. With operations across 50 countries, TFS and its strategic partners provide tailored strategic resourcing solutions and clinical development services in specialized therapeutic areas, including dermatology, internal medicine, neuroscience, oncology, and ophthalmology. Dedicated to empowering partners and enriching lives, TFS offers flexible solutions that combine global reach with the agility and responsiveness of a mid-sized CRO. For more information, visit www.tfscro.com.

Locations

Lund, SE

Website

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