Job Description

Overview:

The Clinical Research Coordinator assists Government directors and PIs in managing clinical research projects, including study enrollment, data collection, budget monitoring, and regulatory compliance. Requires a Bachelor’s degree (Master’s preferred), 2-4 years of experience, strong communication skills, and knowledge of CFR, GCP, and FDA regulations.

Duties & Responsibilities:

• Supports Government directors and Principal Investigators (PIs) in the planning, programming, and execution of clinical research projects and protocols and associated activities.
• Maintains study records in accordance with protocols, study schedules, participant observations, and provides follow-up documentation to the PI.
• For human research studies, assists with study enrollment and activities related to the conduct of the study.
• Coordinates one to several simultaneous projects for the PI/director; confers with investigators on experimental design; provides instruction on various research laboratory techniques, and study participant contact procedures.
• Organizes research information and manages reporting and data collection.
• Monitors the research study budget, researches equipment/supply catalogs, and recommends purchase requests for projects/protocols in accordance with the IRB.
• Documents all regulatory research and administrative actions to ensure study compliance.
• Prepares and delivers required reports and other research documentation to the PI.
• Prepares correspondence, builds study files, develops schedules, and creates presentation graphics to support the research study.
• Utilizes available software systems, including accounts tracking systems, publication submissions, purchase orders, credit card purchases, and preparation of forms for incoming and outgoing funds.
• May require occasional weekend and evening hours.

Minimum Qualification and Experience:

• Required: B.S. in Biological Sciences or a closely related field; Master's degree highly preferred.
• 2-4 years minimum experience in clinical research.
• Demonstrated competence in oral and written communication.
• Must be organized, attentive to detail, and possess a positive, friendly, and professional demeanor.
• Proficiency with computer skills, including at least intermediate-level experience with Excel and other Microsoft Office software.
• Knowledge of CFR, GCP, and ICH guidelines.
• Must successfully complete CITI training and remain current, with completed GCP training and familiarity with GCP in practice.
• Demonstrated FDA regulatory experience.

Why Join Us?

At CICONIX, we are committed to providing high-quality services to support military families. By joining our team, you’ll make a direct impact on the lives of children and families in crisis while working in a supportive, mission-driven environment. We offer flexible remote options, competitive pay, and the opportunity to work on meaningful programs that serve those who protect our country.

CICONIX, LLC is an Equal Opportunity Employer, including disability/veterans. We participate in E-Verify.

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