Clinical Research Associate Freelance

About this role

TFS HealthScience is a leading global mid size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities resourcing and Functional Service Provider (FSP) solutions.

The freelance Clinical Research Associate (CRA) is responsible for managing and monitoring clinical trial sites to ensure studies are conducted in accordance with protocol Good Clinical Practice (GCP) ICH guidelines and applicable regulatory requirements. The CRA will support study sites throughout the clinical trial lifecycle including initiation monitoring and close out activities.

As part of our SRS team you will be dedicated to one sponsor a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.

Key Responsibilities

Conduct on site and remote monitoring visits including site initiation routine monitoring and close out visits
Ensure clinical trials are conducted according to protocol GCP ICH guidelines and applicable regulatory requirements
Review source documentation and Case Report Forms (CRFs) to ensure accuracy completeness and data integrity
Ensure the safety and rights of study participants through proper informed consent procedures and protocol compliance
Verify proper management storage and accountability of Investigational Products
Prepare and submit monitoring visit reports and follow up on identified issues and action items with study sites
Maintain study documentation including Investigator Site Files and ensure timely submission to eTMF
Update CTMS and other project systems with accurate site level information
Support audit and inspection readiness activities when required

Qualifications

Bachelors degree in Life Sciences Nursing or a related field or equivalent experience
At least 1 year of clinical research experience as a CRA CTA or similar role
Good understanding of GCP ICH guidelines and clinical trial processes
Experience with on site or remote monitoring activities is preferred
Strong attention to detail and organizational skills
Ability to work independently and within a cross functional team environment
Strong communication and problem solving skills
Fluent in English

What We Offer

We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration quality and making a difference in the lives of patients.

Our core values of Trust Quality Passion Flexibility and Sustainability guide our decisions and shape our culture. By aligning on these values we foster collaboration innovation and a shared commitment to excellence. Together we make a difference.

A Bit More About Us

Our journey began over 30 years ago in Sweden in the city of Lund. As a full service global CRO we build solution driven teams working toward a healthier future. Bringing together over 600 professionals TFS delivers tailored clinical research services in more than 50 countries offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology Neuroscience Oncology and Ophthalmology.