The Clinical Research Associates (CRA) is responsible for assigned aspects of clinical monitoring and site management in accordance with the Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonization - Good Clinical Practice (ICH-GCP). Site visits are conducted to assess protocol and regulatory compliance, data reliability, and the proper care and treatment of study subjects. Please note: This is not a remote position.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
QUALIFICATIONS / EDUCATION:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
Minimum BS/BA degree.
Minimum 1+ years' experience directly supporting clinical research or relevant experience in medical/scientific area.
Demonstrates working knowledge of GCP, ICH guidelines, ISO Standards, and FDA regulations.
Proficient in Acrobat Adobe, Microsoft Word, Excel, Power Point, and the ability to quickly become proficient in a variety of other computer software programs.
Experience in using EDC and CTMS systems is desirable.
Experience in monitoring clinical trials is desirable.
Excellent oral and written communication skills.
Excellent record-keeping skills; good documentation practice.
Ability to work well in a team environment.
Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines.
A pro-active, committed and motivated attitude.
Flexibility in work hours and readiness to travel. Travel may be up to 75%.