Clinical Research Associate I

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Job description

Job Description:

The Clinical Research Associate I (CRA I) will assist the study lead with coordination, review, processing and implementation of study tools as well as site management and site monitoring at designated clinical research sites. Additionally, this role supports implementing and monitoring clinical study activities to assure adherence to good clinical practices (GCPs), standard operating procedures (SOPs), and study protocols.

Responsibilities:

• Assist in the development of key study documents including protocols and amendments, final study reports, monitoring plans, and site educational and reference materials
• Assist in tracking of study timelines and budgets
• Assist in case report form (CRF) design process including content, form layout, and edit check review
• Coordinate and manage other study-wide activities such as sample handling, drug re-supply, and investor payments
• Demonstrate knowledge of ICH guidelines, FDA regulations, and company SOPs related to clinical studies
• Serve as in-house liaison to assigned clinical sites and contractors for study related questions
• Conduct site qualification, initiation, interim, and close-out visits
• Maintain a complete and updated regulatory file for each assigned site
• Travel up to 30% or as necessary

Preferred Education and Experience:

• Minimum BS / BA (science or health care field) or nursing degree
• 0 - 2 years of experience working in clinical research for a Sponsor company, CRA/field monitor or CRO setting.
• Strong technical knowledge and experience managing most aspects of clinical studies
• Experience in the pharmaceutical industry is desirable

Preferred Skills, Qualifications, or Technical Proficiencies:

• Knowledge of US and GCP/ICH regulations
• Strong interpersonal, problem-solving, and organizational skills
• Attention to detail and ability to prioritize tasks to meet critical deadlines
• Ability to read and understand scientific literature
• Excellent verbal and written communication skills
• Able to work effectively on project teams and independently
• Strong proficiency in Microsoft Office and ability to utilize a wide range of computer applications and tools.