Jobs

Description

8am -5pm

Duties / Responsibilities

The Clinical Research Associate (CRA) will support IVD and specimen collection studies in compliance with Federal Regulations, ICH GCP, FDA, and IRB guidelines.

Responsibilities include:

• Assisting senior staff with study planning and execution; investigator site evaluation, selection, training, and management; and coordination of study meetings.
• The CRA will be responsible for writing and assembling regulatory submissions, drafting basic study protocols and reports, monitoring investigational sites to ensure protocol adherence, ensuring timely patient enrollment, and overseeing CRF retrieval and processing (including data clean up and classification).
• The role includes contributing to study summaries and serving as a lead or mentor to junior CRAs when applicable.
• During the first two weeks, the contractor must be onsite daily to support onboarding, training, and team integration.
• Afterward, the role will transition to hybrid/remote, with periodic onsite attendance required based on business needs.

Experience:

• 5+ years of clinical research monitoring experience, preferably at a Senior CRA level or ready for promotion to Senior CRA.

Key Skills

• Independent site monitoring and site management
• Strong working knowledge of ICH GCP, FDA, and IRB requirements, including audit readiness
• Proven experience reviewing medical records and source documentation
• Strong cross functional communication skills (primary site contact; collaboration with study teams and management)
• Leadership experience, including mentoring junior CRAs and acting as Lead CRA across multiple protocols and sites

Preferred Experience

• Demonstrated career stability with professional growth (not frequent short term roles)
• Experience in the IVD therapeutic area
• Neurology study experience
• Background working for or with a sponsor organization

Education:

• Bachelor’s degree in Life Sciences (required)