CARE Institute is a start-up company firmly established in the research industry. We provide quality clinical research that significantly impacts the health of patients and communities. Our mission is to advance scientific and medical knowledge within the industry.

The clinical research coordinator (CRC) is responsible for all aspects of the clinical trial, ensuring trouble-free running of all clinical trials. This is not limited to one trial at a time. The CRC will be monitoring the study to ensure that it complies with protocols, is ethically conducted and follows regulatory standards. The CRC will work with the Recruitment Specialist and Regulatory Specialist in completing all forms, procedures, and compliance for each trial. Attention to detail and organizational skills are essential for success in this role.

Responsibilities:

• Supervise the daily activities of a study and monitor the activities of the subjects and researchers
• Perform various medical procedures including patient vitals, phlebotomy, run labs, EKG, etc.
• Interact professionally with trial compliance monitors, answer all queries and make necessary corrections
• Dispense medication upon provider approval, provide drug accountability, and chart all actions
• Maintain research records of study activity, including case report forms, drug dispensation records and other regulatory forms as per FDA guidelines
• Ensure equipment and supplies needed for the study are in stock and in good working order
• Run all Source system document generations for each trial
• Provide patient education on all trial details
• Direct the collection, labeling, storage and transport of all specimens
• Review and comprehend the protocol
• Use Clinical Trial Management System (CTMS) to manage subject visits, documentation, and study tracking at the site level

Minimum Qualifications:

• Fluency in Spanish and English required
• GCP and Human Subjects Protection Certification required
• 3-5 years of Clinical Research experience required
• Ability to work independently and in a team environment
• Excellent communication and problem-solving skills
• Attention to detail and organizational skills
• Proficiency in performing EKGs, blood collection, obtaining vitals and documenting medical history
• Good Clinical Practice (GCP)
• Proficiency in Microsoft Office and Google Docs
• Knowledge of medical terminology
• Knowledge of ICH/GCP and regulatory requirements
• Proficiency with Electronic Data Capture (EDC) Systems
• Proficiency with Clinical Trial Management Systems (CTMS) – experience with Clinical Research IO (CRIO) preferred
• Experience with nephrology preferred but not required

Work Environment:

This position works under normal office conditions and in a laboratory/clinic environment. The employee may be exposed to infectious diseases, blood, and bodily fluids.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

The employee must have the ability to lift, pull, push, and manipulate equipment and patients, which requires strength and gross motor and fine motor coordination. The employee must be able to administer prescribed treatments. The position requires sitting and/or standing for long periods of time. The position requires the ability to operate a computer.

CARE is an Equal Opportunity Employer. CARE does not discriminate based on race, religion, color, gender, or sexual orientation.