The Clinical Research Assistant selects and observes subjects and assists with data analysis and reporting. Organizes research information for clinical projects. Being a Clinical Research Assistant requires a high school diploma or its equivalent. Oversees experiment scheduling and collection of data. In addition, Clinical Research Assistant typically reports to a supervisor or manager. Being a Clinical Research Assistant gains or has attained full proficiency in a specific area of discipline. Works under moderate supervision. Working as a Clinical Research Assistant typically requires 1-3 years of related experience. (Copyright 2024 Salary.com)
NextStage Clinical Research Assistant is seeking an experienced Clinical Research Assistant who is self-motivated, driven and works well with others in a collaborative environment to join our team in the Eau Claire, WI Area.
NextStage Clinical Research is a fast growing, integrated site management research organization that is partnering with prominent private practice physician groups to deliver innovative healthcare solutions to more patients. NextStage is poised for accelerated business growth through our experienced team of highly skilled and trained clinical professionals, best in class physicians partners and thought leading leadership team.
Key Job Details:
Job Summary:
The CRCA will coordinate the execution of all clinical study protocol activities while maintaining GoodClinical Practice (GCP) and adhering to the Food and Drug Administration (FDA) regulations. The CRCA’s main responsibility is the conduct of multiple clinical trials, working closely with the Principal Investigator, Sub-Investigators, and support staff.
Essential Duties & Responsibilities:
1. Interprets protocol(s) correctly and completely to ensure consistent compliance with applicable standards and related requirements.
2. Assist in the education of patients and healthcare professionals on the study protocol to ensure complete and correct understanding of information.
3. Reviews medical records against inclusion/exclusion criteria to identify potential subjects.
4. Presents information and responds to questions in accordance with standards of professional practice and compliance requirements in relation to matters including, but not limited to, obtaining informed consent.
5. Maintains and prepares lab kits for subject visits.
6. Assists coordinators with subject visit and Investigator Team.
7. Maintains clinical source records.
8. Organizes Investigator Site Files.
9. Ensures call notes and documentation is accurate.
10. Complies with all regulatory requirements, guidelines, and local regulations.
11. Prepares IRB submissions to include but not limited to development of ICF and any supporting documentation required for submission.
12. Prepares Regulatory documents per sponsor requirements (FDA Form 1572, Financial Disclosure forms, etc.).
13. Coordinates and maintains the following logs: Delegation of Authority, Deviation Logs, Enrollment, Study Status Logs.
14. Attends Site Training.
15. Transcribes source to EDC platforms.
16. Assists Sponsor and Monitor Visits.
17. Demonstrates integrity, teamwork, respect, and accountability in all aspects of the job.
18. Performs job duties and assigned tasks in a safe, efficient, and effective manner, as well as in a manner that is compliant with all company policies, procedures, protocols, and practices.
19. Perform other duties assigned as it relates to the business needs
Minimal Education & Experience Requirements:
Physical Requirements & Working Environment:
This position requires frequent sitting, walking, standing, reading, seeing, speaking, hearing, listening, organizing, interpreting data and information, operating office equipment, typing using a computer keyboard, and viewing a computer screen monitor. The working environment consists of an indoor and climate-controlled setting the majority of the time, and with frequent exposure to a healthcare clinical setting to include, without limitation, frequent potential exposure to blood borne pathogens, and other possible hazards within a clinical setting.
Equal Opportunity Employer
Job Type: Full-time
Pay: From $15.00 per hour
Schedule:
Education:
Ability to Relocate:
Work Location: In person