GENERAL SUMMARY OF DUTIES - Primary responsibilities include processing, tracking and maintenance of regulatory documentation. This position will work closely with the regulatory affairs specialists and project teamsto ensure compliance while meeting strict deadlines.
DUTIES INCLUDE BUT ARE NOT LIMITED TO:
KNOWLEDGE, SKILLS, & ABILITIES - This position requires the following minimal requirements:
- Review, process, and electronically track study-specific regulatory documents, including IRB approvals, credentials, and correspondence;
- Assist in the maintenance of document tracking systems and electronic files as necessary
- Work with regulatory affairs team and project teams to achieve goals for quality assurance and compliance; check for expired credentials and approvals on a routine basis
- Ensures all regulatory documentation is compliant with GCP and local Standard Operating Procedures (SOPs) for format and content.
- Maintain updated credentials and other critical documentation ensuring compliance as assigned.
- Assist with review of informed consent forms
- Assist teams in preparation for internal and external audits; conduct quality checks of essential documents as needed
- Assist any internal or external audit team with any regulatory related issues.
- Participate in educational activities and programs.
- Maintain strictest confidentiality.
- Perform related work as required.
- Ability to work with within deadlines.
- Attention to detail
- Strong interpersonal, communication, and organizational skills a must.
- Working knowledge of MS Office products including Outlook, Word, and Excel.
- Knowledge of medical and clinical research terminology is preferred.
- High school diploma or GED is required.
- Associate's degree in science related field preferred or combination of equivalent education and experience.
- 6 months experience in healthcare, research or other science or regulated field or equivalent of education and experience preferred.
- Or equivalent experience