Clinical Research Study Associate
The primary purpose of the Senior CTA is to work automatously, leading all aspects management of clinical study administration, in compliance with Good Clinical Practice (GCP), regulatory requirements and BioCrucible Standard Operating Procedures (SOPs). Ensuring the clinical study administration is performed such that the subjects’ rights, safety and well-being are protected and that the clinical study data are reliable.
The Senior CTA supports the clinical project team in the following areas:
- Ensuring that the clinical project plan is up to date
- Prepare, handle, distribute, file, and archive clinical documentation and reports
- Owns the Study Master file and is responsible for accuracy and completeness
- Prepare, handle and distribute Clinical Study Supplies and maintain tracking information.
- Onboarding, training new or junior members of the team as needed
- Supporting the implementation of new tools and systems to drive continual improvement and best practice for all BioCrucible clinical studies.
- Perform administrative tasks to support team members with clinical study conduct, as needed.
Primary responsibilities of the position: The Senior CTA will be responsible all administrative activities during preparation, study set up, conduct and close out of Clinical studies, which includes, but is not limited to:
- Document creation, management, retention and archiving, including but not limited to.
- Review of essential documents e.g. Protocol, Monitoring Plan for compliance with clinical SOPs
- May assist in the preparation of essential documentation depending on experience
- Set up and maintenance of the Study Master Files (SMF) and Investigator Master File (IMF) and electronic filing systems, compliant to regulations and in audit ready state
- Site Management, support and logistic
- Responsible for budget management. Collating, tracking & shipping of documentation. Managing monitoring visits scheduled between Clinical Research Associate, site and internal BioCrucible project team. Tracking and liaising with CRA and site to ensure actions are closed out. Instrumentation support and archiving.
- Liaises directly with clinical sites to assist is issue and action resolution.
- Clinical Study Database maintenance activities such as regular transfer of data files, format checking and collation. Furthermore, tracking tools set up and maintenance throughout the study.
- Support CA function during audits e.g. Notified Body, BIMO, FDA, MHRA.
- Liaises with the Clinical Study Manager (CSM) across projects.
- Excellent time-management skills, able to prioritise tasks and work under pressure to meet tight timelines.
- Strong communication skills.
- Organised and results oriented.
- Proactive and able to work flexibly and dynamically.
- Education in scientific or medical field; prior experience in clinical diagnostic or molecular biology research lab preferred
- Min 3 years’ relevant experience in clinical trial planning & implementation in diagnostics or medical devices.
- Experience in working with NHS sites and protocol submission through IRAS
- GCP certified
- Working knowledge of ISO20916 and regulatory requirements for IVD’s
- IT literacy, particularly in Word, Excel and PowerPoint
- Experience with diagnostic clinical trials or previous experience of working in Clinical Research or the Pharmaceutical IndustryPr
If you are interested, then please send a covering letter and CV for the attention of Helen Armes to email@example.com