Senior CRA — Medical Device (Remote)

Kelly Services; Minneapolis (MN); On-site; USD 99,000 - 121,000; Full time

Job summary

Kelly Services is seeking a Senior Clinical Research Associate for a temp-to-hire role with a fast-moving medical device client. The position is remote with domestic travel and involves overseeing trials from start-up to close and ensuring protocol, regulatory, and data quality compliance.

Responsibilities include coordinating site qualification, initiation, and monitoring visits; managing site operations; reviewing informed consents; ensuring product accountability; and supporting study

Qualifications

• Bachelor's Degree or higher in healthcare or science; relevant experience may be considered.
• Minimum 5 years' experience as a Clinical Research Associate
• At least 3 years of monitoring Class III medical device trials
• Proficiency with Epic
• Thorough knowledge of clinical research concepts, FDA regulations, and GCP
• Strong organizational, communication, and critical thinking skills
• Willingness to travel domestically 25-50%
• Experience in breast cancer, breast reconstruction, or related therapeutic areas preferred
• Proficient in Microsoft Office and comfortable learning new trial management systems

Responsibilities

• Oversee the execution of clinical trials from site start-up to site closure, ensuring compliance with study protocols, regulatory requirements, and quality documentation.
• Coordinate and conduct site qualification, initiation, and monitoring visits; manage site operations.
• Review informed consent procedures; assess investigational product accountability.
• Support development of study documentation and site-facing materials.
• Develop strong relationships with clinical site staff; proactively identify and mitigate risks.
• Facilitate timely communication among stakeholders.

Skills

Clinical monitoring

Regulatory compliance

Documentation quality

Communication skills

Travel readiness

Education

Bachelor's degree in healthcare/science

Tools

Epic

Microsoft Office

Job description

Kelly Services is seeking a Senior Clinical Research Associate for a temp-to-hire role with a fast-moving medical device client. The position is remote with domestic travel and involves overseeing trials from start-up to close and ensuring protocol, regulatory, and data quality compliance.

Responsibilities include coordinating site qualification, initiation, and monitoring visits; managing site operations; reviewing informed consents; ensuring product accountability; and supporting study