Works under limited supervision and oversees the day-to-day activities of a clinical trial in accordance with Good Clinical Research Practice (GCP). Performs a variety of research activities in support of clinical trials (including database management, biological specimen processing, and clerical duties) to assist investigators in organizing, gathering and compiling clinical research data. Recruits, assists with consenting subjects, and conducts study visits. Performs a variety of research, data base, biospecimen collection and processing, as well as clerical duties in support of clinical trials to assist investigators in organizing, gathering and compiling clinical research data. Organizes and maintains documentation required for clinical trial(s). Informs Principal Investigator and/or designated individual on any issues concerning patients response to treatment/medication/ any adverse effects overall to patients. Assists Principal Investigator with regulatory body filings including IRB submissions. May assist in the enrollment of human subjects. May provide clerical and technical support to ensure adherence to research protocols and quality of information received. Competencies (Knowledge, Skills, and Abilities Required): Knowledge of and the ability to utilize technology tools to organize, store and manage database systems. Knowledge of and ability to utilize tools, techniques and processes for gathering and reporting data in a particular department or division of a company. Knowledge and understanding of legislation and regulatory bodies affecting healthcare practices Knowledge of principles and practices associated with the rights and responsibilities of patients and caregivers. Ability to manage multiple concurrent objectives, projects, groups, or activities, making effective judgments as to prioritizing and time allocation.
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Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED