Senior Clinical Research Associate – Medical Device

This is a fully remote position, open to applicants in Illinois, +6 more states.

📋 Description

• Oversee clinical trial monitoring activities that demand technical expertise, emphasizing quality and ongoing enhancement.

• Evaluate clinical trial sites to ensure compliance with study protocols, regulatory mandates, and Good Clinical Practice (GCP) standards.

• Conduct site visits to evaluate performance, address issues, and support effective trial implementation.

• Collaborate with interdisciplinary teams to guarantee timely and precise data gathering and reporting.

• Offer training and support to site personnel and other Clinical Research Associates (CRAs).

• Establish and nurture productive relationships with site staff and stakeholders to ensure seamless trial operations.

⛳️ Requirements

• A bachelor’s degree is essential, ideally a Bachelor of Science in Life Science, Physical Science, Nursing, or Biological Science.

• 3-5 years of experience as a CRA in CRO/pharmaceutical settings.

• Strong preference for a minimum of 1 year of medical device monitoring experience; complex pharmaceutical monitoring experience will also be considered.

• Comprehensive understanding of FDA regulations and ICH/GCP guidelines.

• Excellent problem-solving abilities to mitigate risks, identify site issues, and implement prompt and effective solutions.

• Strong interpersonal skills for establishing and maintaining effective working relationships with site staff, investigators, and internal teams.

• Outstanding verbal and written communication skills, capable of conveying complex information in a clear and concise manner.

• Ability to adapt communication styles to meet the needs and preferences of various stakeholders, promoting a collaborative atmosphere.

• Capability to work independently and manage multiple priorities in a fast-paced environment.

• A well-organized communication strategy for engaging with study teams and sites.

• Proficient in clinical trial management; meticulous, detail-oriented, and precise in documentation.

• Willingness to travel as necessary (approximately 60%).

• Legal authorization to work in the country where the position is located.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs including medical, dental, and vision coverage where applicable.

• Retirement and pension schemes.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Learning and development opportunities through structured training and career pathways.