Vita Global Sciences, a Kelly Company ยท 3 days ago
Sr. Clinical Research Associate
Vita Global Sciences, a Kelly Company, is seeking a Regional Clinical Research Associate for a long-term engagement with a Global Medical Device client. This role involves supporting 1-3 protocols in the cardiovascular/electrophysiology medical device space and requires strong knowledge of FDA regulations and clinical trial management.
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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/ be: 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 reports
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
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 reports
Preferred
Cardiovascular medical device monitoring experience- however, cardiovascular/electrophysiology pharma monitoring experience will be considered
Benefits
Medical
Dental
Vision
401K
Paid time off
Holiday
Vacation
Sick/personal time