Clinical Research Assistant

Duties and Responsibilities

• Affords assistance in the creation and completion of study-related documents and new study preparations.
• Affords support in the completion of regulatory submissions and maintenance of regulatory files as directed.
• Serves as a secondary liaison with sponsors.
• Affords support in the preparation for study monitor visits as directed.
• Affords support in completing case report forms as directed.
• Affords support in creating reports as requested.
• Affords support in conducting study-directed assessments with patients, including but not limited to adverse events, test article (TA) handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment.
• Affords support in subject screening and recruitment as directed.
• Affords support in updating Clinical Trial Management Software (CTMS) as directed.
• Coordinates multiple projects with competing priorities and deadlines, as needed based on clinical trial protocol directives and study volume.
• Interacts with internal and external personnel, including but not limited to physicians, nurses, administration staff, industry sponsor representatives, central laboratory/imaging personnel, and clinical trial patients.

Education & Experience

A 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. Clinical research certification preferred.

Knowledge, Skills, and Other Abilities

• 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 Environment and Physical Demands

The work environment and 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 accommodations may be made to enable individuals with disabilities to perform the essential functions. 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. Occasional travel may be required domestic and/or international. 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.