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Job Summary:

Under direct supervision of leadership, the Clinical Research Coordinator (CRC) ensures study compliance with local, state, and federal laws and regulations. The CRC performs a critical role in the conduct of clinical research by performing the day-to-day support operations of the research trials. The CRC works closely with the Principal Investigators, study sponsor, study monitors, and site departments.

Essential Functions & Responsibilities:

• Conducts screening, recruitment, and verification of subject eligibility criteria.
• Explains informed consent to potential study subjects, answers study specific questions, and completes the informed consent process.
• Performs research related activities, including study drug accountability and the collection and processing of specimens required per the study protocol and IATA regulations.
• Confirms any potential subject adverse events or serious adverse events, and reports the adverse events as needed.
• Completes case report forms and data entry to maintain all documents and records related to the study.
• Supports, coordinates, and maintains clinical trials with the required training; including Good Clinical Practice (GCP) training, dangerous goods training and sponsor specific training.
• Works closely with study monitors at the site initiation visits, monitoring visits, close out visits, and throughout the duration of the study to answer any queries when needed.
• Manages all study supplies and equipment related to the study.
• Maintains quality, safety, and/or infection control standards.
• Performs other duties as assigned to ensure study compliance and progress.

Qualifications:

• High School diploma or equivalent required; Bachelor's degree or an allied health professional degree preferred.
• A minimum of one year of clinical research experience preferred.
• Certified Clinical Research Coordinator or certification after 2 years of clinical research experience, preferred.
• Understanding of medical terminology required.
• Phlebotomy and general clinic assessment skills (vital signs and EKG) preferred.
• Ability to understand and follow complex, detailed technical instructions and follow basic scientific research protocol and procedure required.
• Proficiency with MS Office (Word, Excel, Access, and PowerPoint), email, and internet required.

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, color, religion, sex, sexual orientation, gender identity, national origin, and veteran or disability status.