Kelly Science, Engineering, Technology & Telecom · 4 hours ago
Senior Clinical Research Associate
Kelly Science and Clinical FSP is currently seeking a Regional Clinical Research Associate for a long-term engagement with a Global Medical Device client. The role involves supporting protocols in the cardiovascular/electrophysiology medical device space, requiring strong monitoring experience and knowledge of FDA regulations and ICH/GCP guidelines.
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
Qualification
Required
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
Preferred
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
Company
Kelly Science, Engineering, Technology & Telecom
Kelly Science, Engineering, Technology & Telecom specializes in science, engineering, technology, and telecom.