Clinical Affairs Specialist U.S.

Nordberg Medical; Dallas (TX); Remote; USD 60,000 - 80,000; Full time

Job summary

A biotechnology and medical devices company in Dallas is seeking a Clinical Affairs Specialist to support clinical studies across North America. The role involves monitoring trials, ensuring compliance with regulations, and coordinating with CROs. Ideal candidates have at least 2 years of experience in clinical trials and a Bachelor’s degree in Life Sciences. This is a full-time, remote position with frequent travel to clinical sites within the U.S.

Qualifications

• Minimum 2 years’ experience at a CRO company with clinical trials.
• Strong understanding of Good Clinical Practice (GCP) and clinical research operations.

Responsibilities

• Monitor clinical trial activities at U.S. study sites for compliance.
• Coordinate with vendors and CROs for study logistics.
• Assist in preparing monitoring reports and resolve issues.

Skills

Clinical trial monitoring

Knowledge of FDA regulations

Collaboration

Problem-solving

Education

Bachelor’s degree in Life Sciences

Job description

Overview

We are seeking a Clinical Affairs Specialist based in the U.S. to support the monitoring and execution of our clinical studies across North America. This is a unique opportunity to become the first on-site member of our Clinical Affairs team in the United States, playing a key role in strengthening our local presence.

The role is ideal for a clinical research professional with direct experience from a CRO company within the medical device or pharmaceutical industry. You will work closely with investigators, CROs, and study site personnel to ensure that clinical trials are conducted in accordance with applicable regulatory guidelines, study protocols, and internal SOPs.

As part of the global Clinical Affairs team, you will report to the Clinical Affairs Director and collaborate with colleagues across regions.

Responsibilities

• Monitor clinical trial activities at U.S. study sites to ensure compliance with protocol, GCP, and regulatory requirements.
• Coordinate with vendors and CROs to manage study-related logistics, including drug/device shipments, supplies, and documentation.
• Participate in team meetings and provide updates on site status, challenges, and milestones.
• Assist with the preparation of site monitoring reports and ensure timely resolution of outstanding issues.
• Support U.S.-specific regulatory documentation and IRB communication when needed.

Qualifications

• Education/Background: Bachelor’s degree in Life Sciences, Health Sciences, or another relevant field. Background as a Registered Nurse (RN) is considered beneficial.
• Experience: Minimum 2 years’ experience working at a CRO company with clinical trials, ideally with hands-on involvement in on-site monitoring or coordination.
• Knowledge: Strong understanding of Good Clinical Practice (GCP), FDA regulations, and clinical research operations within the U.S.

Personality

• Ambitious & Accountable - you are driven to achieve bold goals while taking responsibility for your actions, delivering on promises, and contributing to collective success.
• Solutions-Oriented - you focus on possibilities rather than obstacles, learn from experience, and bring forward ideas that move the business ahead.
• Resilient - you remain steady and positive through challenges, bounce back from setbacks, and celebrate progress along the way.
• Collaborative & Respectful - you embrace different viewpoints, assume good intent, and work together to achieve shared success.

Other Information

This is a full-time, remote-based position located in the United States. The role involves frequent travel to clinical sites within the U.S. (approximately 60% / 3 days per week), as well as occasional travel to Europe. Employment will be through Nordberg Medical (US) Inc. Candidates must be legally authorized to work in the United States, as visa sponsorship is not available for this position.

About Nordberg Medical

Nordberg Medical is a biotechnology and medical devices company developing next-generation biomedical solutions that bridge nature and science. Rooted in Swedish heritage and driven by science, we deliver advanced biomaterials that unlock the body’s regenerative potential in medical aesthetics and beyond. We are passionate about uncovering the biological aging process and designing life-changing medical treatments. Our mission is to restore, enhance and elevate – through evidence-based and clinically validated innovation that puts both safety and human impact first. Our work is guided by progress, excellence and a long-term vision. As a trusted partner to healthcare professionals worldwide, we light the way in biotechnological progress.