[Remote] Senior Clinical Research Associate

Note: The job is a remote job and is open to candidates in USA. Kelly Science and Clinical FSP is seeking a Regional Clinical Research Associate for a long-term engagement with a Global Medical Device client. The role involves supporting clinical protocols in the cardiovascular/electrophysiology medical device space, requiring strong monitoring and communication skills.

Responsibilities

• To support 1-3 protocols in the cardiovascular/electrophysiology medical device space
• The ideal candidate will have cardiovascular medical device monitoring experience- however, cardiovascular/electrophysiology pharma monitoring experience will be considered
• 5 years of monitoring experience required
• Candidates must have in-depth knowledge of FDA regulations and ICH/GCP guidelines
• Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly
• Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams
• Exceptional verbal and written communication skills, with the ability to convey complex information clearly and concisely
• Ability to tailor communication style to the needs and preferences of different stakeholders, fostering a collaborative environment
• Ability to work independently and manage multiple priorities in a dynamic environment
• A well-executed plan for communication with the study teams and sites
• Well-versed in clinical trial management. They are rigorous, detail-oriented, and precise in their report

Skills

• 5 years of monitoring experience required
• Bachelor's degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science
• Candidates must have in-depth knowledge of FDA regulations and ICH/GCP guidelines
• Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly
• Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams
• Exceptional verbal and written communication skills, with the ability to convey complex information clearly and concisely
• Ability to tailor communication style to the needs and preferences of different stakeholders, fostering a collaborative environment
• Ability to work independently and manage multiple priorities in a dynamic environment
• A well-executed plan for communication with the study teams and sites
• Well-versed in clinical trial management. They are rigorous, detail-oriented, and precise in their report
• The ideal candidate will have cardiovascular medical device monitoring experience- however, cardiovascular/electrophysiology pharma monitoring experience will be considered

Benefits

• Medical
• Dental
• Vision
• 401K
• Paid time off, including holiday, vacation, and sick/personal time

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