Clinical Research Coordinator Associate
3 days ago
The Clinical Research Coordinator Associate is a key member of the clinical trials research team at Stanford University. This role is responsible for the overall management and implementation of assigned research protocols, ensuring efficiency and regulatory compliance. The successful candidate will work closely with Principal Investigators, research participants, and regulatory agencies to ensure the success of clinical trials.
Key Responsibilities:
- Prepare initial study documents for IRB submission, ensuring compliance with local, state, and federal regulations.
- Recruit, screen, and enroll subjects in accordance with good clinical practice guidelines.
- Collect, record, and maintain complete data files, adhering to HIPAA regulations.
- Participate in data retrieval, reporting, and preparation of files and Case Report Forms.
- Interact with subjects, scheduling diagnostic and research evaluation visits, and performing study-related assessments.
- Maintain drug accountability, study supplies, and equipment.
- Oversee subject compliance to the study protocol and report findings to physicians.
- Report serious adverse events promptly to investigators, sponsors, and the IRB.
Requirements:
- Two-year college degree and two years of related work experience or a Bachelor's degree in a related field.
- Strong interpersonal skills and proficiency with Microsoft Office.
- Knowledge of medical terminology and certification from the Society of Clinical Research Associates or Association of Clinical Research Professionals is preferred.
Working Conditions:
- Occasional evening and weekend hours.
Stanford University is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
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