Clinical research coordinator Jobs in Orange, CA

About Us

Össur is a leading global provider of innovative mobility solutions that help people live a Life Without Limitations®. Significant ongoing investment in research and development has led to over 2,100 patents, award-winning designs, and successful clinical outcomes.

Össur is focused on improving people’s mobility through the delivery of Prosthetics and Bracing & Supports solutions. Helping people live a Life Without Limitations is why we exist as a company.

About the Role

As a Clinical Research Scientist, you will be part of a team that plays a critical role in the creation and maintenance of clinical documentation for medical device technical files. You will identify, accumulate, review, and appraise clinical data from published literature and databases. You will manage the planning and execution of clinical studies for products from conception through testing and final reporting. Additionally, you will drive collaboration between cross-functional teams, including R&D, marketing, and global product management, to ensure that clinical research and documentation support product development goals.

What You’ll Do

Clinical Documentation:

• Creation and review of critical clinical documents, including literature reviews, clinical evaluation reports, research protocols, trial outcome reports, and Institutional Review Board (IRB) submissions.

• Ensure accurate and high-quality medical writing for product information, including clinical content for regulatory filings.

• Provide strategic direction for drafting and reviewing clinical documentation in collaboration with internal and external stakeholders.

Clinical Research Management:

• Design, implementation, and manage internal clinical research studies, ensuring alignment with organizational goals and regulatory requirements.

• Supervise both qualitative and quantitative research processes, ensuring that studies are conducted efficiently and produce high-quality data.

Teamwork:

• Coordinate with cross-functional teams, including R&D, marketing, and global product management, to ensure alignment with clinical research goals and product timelines.

• Drive accountability and ensure that all teams meet project deadlines, while maintaining high standards of clinical integrity and compliance.

Compliance & Quality Management:

• Ensure that all clinical research activities comply with regulatory requirements, quality standards, and company policies.

General:

• All employees must be aware, have knowledge and shall have received general training in Quality requirements of Össur. Training takes place in the Onboarding process and in New Employee Orientation. More specific Quality training is job specific.

• All training related to the quality management system is done in accordance to the Training Management Process.

• Exercises good use of company funds and property within the set guidelines. Maintains an honest and professional attitude as the company’s representative at all times.

• Contributes to a safe working environment by maintaining own workspace and reporting any potential hazards.

Who You Are

Education:

• Bachelor's degree in engineering, life sciences, or a related field; or a qualified healthcare professional (e.g., Certified Orthotist, Physical Therapist, Occupational Therapist, Athletic Trainer, Nurse, Medical Doctor).

  A Master's degree or relevant certifications (e.g., Certified Medical Writer, Certified Research Associate) is a preferred.

Experience:

• At least 3-5 years of experience in clinical research or regulatory documentation management for medical devices, with a proven track record of managing projects.

• Strong experience in leading clinical studies, regulatory documentation, and cross-functional collaboration.

• Previous experience with medical writing, clinical evaluation reports, and preparing documentation for regulatory filings (e.g., FDA, CE Mark).

Skills:

• Excellent communication and presentation skills, with the ability to communicate complex concepts clearly to both technical and non-technical stakeholders.

• Strong organizational and project management skills, with the ability to prioritize and manage multiple projects simultaneously.

• Expertise in MS Office applications (Word, PowerPoint, Excel), and familiarity with clinical research databases or regulatory submission platforms.

• Experience with DistillerSR a plus.

• Strong attention to detail and a commitment to high-quality work.

• Ability to collaborate effectively with diverse teams, both within the organization and externally.

• Exceptional problem-solving skills and a proactive approach to overcoming challenges in clinical research and documentation.

Why You’ll Feel Good Working Here

Join our team if you want to make a lasting impact; we will support you along the way.

• We value a diverse working environment and a welcoming and fun company culture

• We empower our colleagues and encourage close collaboration, allowing us to develop the best products and maintain the highest possible standards of care

• Competitive Compensation Packages

• Medical, Dental, and Vision Benefits

• 401(k) Retirement Plan with employer matching contribution

• 9 paid holidays

• 13 vacation days, birthday and two (2) volunteer day

• 8 sick days within your first year of employment

• Paid Parental Bonding

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee must frequently lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.

The US base pay range for this full-time position is $92,206- $113,807 + bonus + benefits. Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire pay rates. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

Össur is a leading global provider of prosthetics and bracing and supports solutions.

Important Warning: Beware of fraudulent recruiters impersonating our company. Please take extra caution when asked for any sensitive personal information, such as social security numbers or bank account details. We will never ask you for any form of payment during the recruitment process. Please make sure you refer to our .