Regulatory Office Assistant
3 weeks ago
**Job Advert Summary**:
The Regulatory Coordinator will report to the Clinical Research Director and site principal investigators. This position is offered on a 13 Month contract.
**Minimum Requirements**:
**Minimum requirements**:
- A 3 year degree or diploma in the social and human sciences or related fields or relevant certification, qualification or experience
- Current GCP certificate
- Ability to use Microsoft Word
- Good interpersonal, organisational and problem solving skills
- Ability to work accurately, independently and in a team
- Ability to work to strict deadlines and attention to detail
- Legal understanding
- Commitment to working as part of multi-disciplinary research team;
- Willingness to work after hours and over weekends and in rural communities
Applicants will be required to take a practical skills assessment test as part of the interview process.
**Duties and Responsibilities**:
**Key responsibilities**:
- Prepares and maintains IRB submissions and Regulatory documents
- Monitors and maintains Standard Operating Procedures (SOPs) across studies
- Monitor trial procedures
- Observe conduct to evaluate ethical code adherence
- Submit data and findings reports to regulatory agencies.
- Tracks study progress in Clinical Trial Management systems
- Act as a liaison for regulatory agencies and effectively impart information to the clinical trial managers.
**Additional Responsibilities**:
- Must be able to keep track of multiple streams of information.
- Must also be able to clearly and accurately record this information
- Must also be able to generate verbal and written reports of your observations.
- Must be able to operate a number of computer systems for tracking data and generating reports and presentations.
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