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Job summary
A leading MedTech CRO is seeking a Senior Clinical Research Associate (Sr. CRA) to manage site monitoring visits and ensure compliance with clinical practices. This role requires at least 4 years of on-site monitoring experience and a bachelor's degree, preferably in a health care field. The Sr. CRA will be responsible for project management, mentoring clinical staff, and collaborating with study teams for successful execution. Strong regulatory knowledge and proficiency in Microsoft Office are essential.
Qualifications
Requires at least 4 years of on-site monitoring experience.
Equivalent combination of education, training and experience considered.
Responsibilities
Conduct site monitoring visits in accordance with regulatory requirements.
Work with sites to track subject recruitment plan.
Administer study-specific documents and training at sites.
Evaluate quality and integrity of study site practices.
Manage progress of assigned studies.
Ensure documentation in the Trial Master File.
Create and maintain site management documentation.
Act as a mentor for clinical staff.
Collaborate with study team for project execution support.
May support development of subject recruitment plan.
Manage site financials according to clinical trial agreements.
Skills
In-depth knowledge of regulatory requirements
Strong therapeutic and protocol knowledge
Proficiency in Microsoft Office
Written and verbal communication skills
Organizational skills
Financial management skills
Education
Bachelor's Degree in scientific discipline or health care
Nursing degree preferred
Job description
A leading MedTech CRO is seeking a Senior Clinical Research Associate (Sr. CRA) to manage site monitoring visits and ensure compliance with clinical practices. This role requires at least 4 years of on-site monitoring experience and a bachelor's degree, preferably in a health care field. The Sr. CRA will be responsible for project management, mentoring clinical staff, and collaborating with study teams for successful execution. Strong regulatory knowledge and proficiency in Microsoft Office are essential.