Freelance Senior Clinical Research Associate 04 FTE

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

Join Our Team as a Freelance Senior Clinical Research Associate (0.4 FTE) (home based in Poland).

About this role

As part of our Site Management team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals.

The Freelance Senior Clinical Research Associate will function operationally as a member of a Project Team and is responsible for the initiation onsite and/or remote monitoring and close out of study sites during study conduct according to company policies SOPs and regulatory requirements.

Key Responsibilities:

• Monitor onsite and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures GCP and ICH guidelines and applicable regulatory regulations. Perform all required monitoring activities at the study sites to assess and ensure subjects safety data integrity and quality.
• Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations.
• Review CRFs (electronic or paper) and subject source documentation for validity and accuracy
• Verify proper management and accountability of Investigational Product
• Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings corrective and preventive actions already taken and update applicable tracking systems as required; escalate observed deficiencies and issues as appropriate.
• Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner.
• Timely delivering site documents to eTMF or paper TMF.
• Verify that the Investigators Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements.

Qualifications:

• Bachelors Degree preferably in life science or nursing; or equivalent
• At least 5 years experience as CRA including relevant onsite monitoring experience.
• Able to work in a fastpaced environment with changing priorities.
• Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas.
• Possess the understanding of Good Clinical Practice regulations ICH guidelines.
• Ability to work independently as well as in a team matrix organization.
• Excellent written and verbal communication skills
• Fluent in English and Polish
• Excellent organizational skills
• Technology savvy and good software and computer skills
• Soft skills requirements: Selfawareness resolute flexibility collaborative mindset proactivity analytic approach and attention to detail coach ability motivated to take on new challenges facilitation of discussion diplomacy in difficult situations.
• Ability to take the ownership of the assigned tasks.
• Ability to manage complex or early phases studies.
• Ability and willingness to travel up to 6080% overnight and abroad if applicable.

What We Offer

We provide a competitive compensation package comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. Youll be joining a team that values collaboration innovation and making a difference in the lives of patients

A Bit More About Us

Our journey began over 27 years ago in Sweden in the city of Lund. As a fullservice global Contract Research Organization (CRO) we build solutiondriven teams working towards a healthier future. Bringing together over 800 professionals TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology Neuroscience Oncology and Ophthalmology.

Our core values of Trust Quality Passion Flexibility and Sustainability are our guiding light serving as the framework for decisionmaking at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments resulting in high employee engagement and satisfaction. By aligning on these fundamental values we cultivate a unified force geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.