
Clinical Research Assistant
2 semanas atrás
Perform a variety of administrative tasks in support of clinical trials and assist in the performance of clinical procedures to collect data on patients enrolled and/or seeking enrollment in clinical studies.
**Essential Functions**
- Provide clinical research support to investigators and site staff, including
- Verify and/or correct research study information on source documents; research queries and variances; and provide
feedback to the site data collector.
- Input research study data into trial Electronic Data Capture (EDC) system, maintaining quality control for content,
accuracy, and completeness.
- Prepare and maintain research study files. Compile, collate and submit study information within established deadlines.
- Collect and submit regulatory/ethics documentation pertaining to the research study.
- Maintain the FDA 1572 form for assigned research studies.
- Input visit data into clinical trial management system (CTMS) to track patient visits and procedures completed against the study budget.
**Qualifications**
- High School Diploma or equivalent High School Diploma
- Educational equivalent and 2 years’ relevant work experience in a clinical environment or medical setting; or equivalent combination of education, training and experience
- Basic knowledge of clinical trials
- In-depth knowledge of departmental, protocol and study-specific operating procedures, consent forms, and study
schedules
- Basic knowledge of medical terminology
- Excellent interpersonal skills
- Ability to pay close attention to detail
- Ability to establish and maintain effective working relationships with coworkers, managers and clients
- Applicable certifications and licenses as required by the company, country, state, and/or other regulatory bodies
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