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About the Role

Assists the Clinical Research Coordinator and principal investigator with administering clinical research activities, ensuring compliance with protocols, regulations, and institutional policies. Maintains subject and document confidentiality while acting as a liaison with sponsors and internal/external personnel.

Responsibilities

• Assists with the creation and completion of study-related documents and new study preparation.
• Assists with the completion of regulatory submissions and maintains regulatory files.
• Acts as a secondary liaison with sponsors.
• Assists with the preparation for study monitor visits.
• Completes case report forms.
• Creates reports as requested.
• Completes study-directed assessments with patients, including adverse events, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment.
• Assists with subject screening and recruitment.
• Updates Clinical Trial Management Software (CTMS).
• Coordinates multiple projects with competing priorities and deadlines.
• Interacts with internal and external personnel, including physicians, nurses, administration staff, industry sponsor representatives, central laboratory/imaging personnel, and clinical trial patients.

Requirements

• High school diploma or general education degree (GED); or two to four years related experience and/or training; or equivalent combination of education and experience.
• Ability to demonstrate competence in oral and written communication.
• Bilingual (English/Spanish) required.
• Must be organized, attentive to detail, and possess a positive, friendly, and professional demeanor.
• Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner.
• Medical knowledge, including medical terminology.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write routine reports and correspondence.
• Ability to speak effectively before groups of customers or employees of the organization.
• Must have knowledge of Microsoft Office Word, Microsoft Excel, Internet Explorer, Google Chrome, Mozilla Firefox, web-based enterprise solutions, and Electronic Case Report Form systems.
• Work is performed in an office/laboratory and/or a clinical environment.
• Exposure to biological fluids and/or bloodborne pathogens.
• Personal protective equipment required such as protective eyewear, garments, and gloves.
• Ability to work in an upright and/or stationary position for 6-10 hours per day.
• Frequent mobility required.
• Occasional squatting, kneeling, or bending.
• Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.

Skills

• Oral and written communication
• Bilingual (English/Spanish)
• Organization
• Attention to detail
• Professional demeanor
• Flexibility with changing priorities
• Diplomatic communication
• Medical terminology
• Document interpretation
• Report writing
• Public speaking
• Microsoft Office Word
• Microsoft Excel
• Internet Explorer
• Google Chrome
• Mozilla Firefox
• Web-based enterprise solutions
• Electronic Case Report Form systems

Location

• Office/laboratory and/or a clinical environment

Work Type

• Full-time

Experience Level

• Two to four years related experience and/or training

Education Level

• High school diploma or general education degree (GED)