Senior Clinical Research Associate

TFS HealthScience; Denmark; Remote; DKK 112,000 - 167,000; Part time

Benefits offered by this job

Home-based role in Denmark

Competitive compensation package

Job summary

TFS HealthScience is seeking a Freelance Senior Clinical Research Associate (0.1 FTE) based in Denmark. You will monitor ophthalmology trials on-site and remotely, ensuring protocol compliance, data integrity and patient safety across study sites.

The role requires 5 years of independent monitoring, 1 year unmasked monitoring, and ophthalmology experience. Travel up to 60–80% domestically and abroad may be required, with a strong emphasis on regulatory adherence and collaboration with sponsors.

Qualifications

• Bachelor’s Degree in life science or nursing, or equivalent.
• 5 years of independent on-site monitoring experience and at least 1 year unmasked monitoring.
• At least 1 year Ophthalmology experience, retina preferred.
• Fluent in English and Danish.

Responsibilities

• Monitor on-site and remote clinical trials in accordance with SOPs, GCP and ICH guidelines.
• Perform monitoring activities at study sites to assess subject safety, data integrity and quality.
• Verify informed consent procedures and protocol adherence.
• Review CRFs and source documentation for validity and accuracy.
• Ensure Investigational Product accountability and proper management.
• Timely reporting of monitoring visits and updating tracking systems.
• Escalate deficiencies and actions required to project teams.
• Deliver site documents to eTMF or TMF and maintain ISF per regulations.
• Update CTMS with accurate site-level information.
• Participate in audits/inspections and follow-up activities.
• Order, ship, and reconcile clinical supplies as needed.
• Mentor CRAs and contribute to training and capability development.

Skills

On-site monitoring

Remote monitoring

Ophthalmology knowledge

GCP/ICH

Travel willingness

Education

Bachelor’s Degree in life science or nursing

Tools

CTMS

eTMF

Job description

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 (FSP) solutions.

Join Our Team as a Freelance Senior Clinical Research Associate (0.1 FTE) - home based in Denmark.

Once sponsor requirements are confirmed, our Talent Acquisition Team will reach out to candidates whose experience best aligns with the project needs.

About this role

As part of our Ophthalmology team you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals. The Freelance Senior Clinical Research Associate is part of Clinical Development Services (CDS) within TFS HealthScience, will function operationally as a member of a Project Team and is responsible for the initiation, on-site and/or remote monitoring and close out of study sites during study conduct, according to company policies, SOPs and regulatory requirements.

The Freelance Senior Clinical Research Associate will provide Unmasked Clinical Research Associate support for assigned clinical studies, including management of investigational product accountability, oversight of unblinded site activities, and monitoring of protocol compliance in accordance with study requirements and applicable regulations.

The Freelance Senior Clinical Research Associate will collaborate with study teams, investigative sites and sponsors to ensure timely execution of study deliverables while maintaining the integrity of study blinding and data quality.

Key Responsibilities

• Monitor on-site 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; escalation 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 Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements.
• Update CTMS and all other required by projects systems with accurate site level information.
• Participate in audit and/or inspection, it’s preparation and follow-up activities, as needed.
• Order, ship, and reconcile clinical investigative supplies for study sites, if applicable.
• May assist the Clinical Research Manager or Project Manager in certain aspects of project activities which may include: project tracking, monitoring plans, Review of monitoring reports CRA resources management within the project.
• May perform Assessment Site Visits (ASV) when requested.
• May act as a mentor to CRAs.
• May develop and implement therapeutic area training for other CRAs and project team members.
• May participate in capabilities presentations.
• Ability to take the ownership of the assigned tasks.
• Ability to manage complex or early phases studies.
• Ability and willingness to travel up to 60-80%, overnight and abroad, if applicable.

Qualifications

• Bachelor’s Degree, preferably in life science or nursing; or equivalent
• 5 years of independent on-site monitoring experience and at least 1 year experience as an unmasked monitor is required.
• At least 1 year Ophthalmology, ideally within a retina indication (i.e. Age-related Macular Degeneration, Diabetic Macular Edema, Geographic Atrophy, RVO, BRVO, CRVO, etc.), experience is preferred.
• Able to work in a fast-paced 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 local language.
• Excellent organizational skills.
• Technology savvy and good software and computer skills.

Soft skills requirements: Self-awareness, 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.

What We Offer

We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll 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 25 years ago in Sweden, in the city of Lund. As a global CRO with the ultimate goal of ensuring patients’ safety and well-being, we provide biotechnology and pharmaceutical companies with tailored clinical development solutions. We currently operate in 17 countries across Europe, North America, Asia Pacific and the Middle East. Our core values of Trust, Quality, Flexibility and Passion are what make TFS Healthscience the successful company it is today. Our values shape our culture and work ethic. They reflect what we stand for and guide our organization. #Together we make a difference