A new Drug Safety Administrator position has become available with a CRO based in Hertfordshire, UK.
As Drug Safety Administrator you will manage project administration including filing, photocopying, printing and other duties, for clinical, regulatory and medical affairs projects. In this position, you will develop the skills required to monitor the conduct of clinical trials and manage clinical study sites. Previous project administration experience would be beneficial for this position.
The key responsibilities of this Drug Safety Administrator position, will include:
- Photocopying, printing and collation of scientific documents as required
- Responsible for the administrative aspects of Ethics Committee submissions and subsequent communications and updates
- Set up of Trial Master Files (TMF) – both in hard copy and electronic format; maintain the TMF throughout the course of the project under direction of the Lead CRA
- Manage study material distribution and receipt at appropriate stages of the study, under direction of the lead CRA
- Responsible for administrative aspects of Competent Authority submissions and subsequent communications and updates
- Keep agency correspondence logs up to date
- Assist in preparing documents for regulatory submissions
- Assisting the review and formatting of promotional materials and other documents as required
- Assist with logistical operations for the client facing team including external meeting and related travel arrangements
- Keep and maintain records on the projects, coordinate meetings and TCs, circulate contact report
- Liaise with the Clinical Operations, Regulatory Affairs & Drug Safety and Medical Affairs staff to ensure timely, high quality and profitable delivery of projects
- Preparation of scientific and promotional materials as required
- Any ad hoc administrative assistance as requested by line manager
- Assist in the management of clinical projects in 100% compliance with ICH-GCP, relevant SOPs, local regulations, other applicable laws and guidelines, and within the agreed timeline
Qualifications & Experience
To be considered for this Drug Safety Administrator role you must have the following qualifications and experience:
- BSc or higher
- Research Nursing Experience
- Clinical Trial Assistant experience
For more information, or to apply for this Drug Safety Administrator position, please contact Hendre Moolman at CK Clinical on +44 (0)1438 870 023 or email firstname.lastname@example.org quoting 20724 to indicate your interest.