Research nursing support for
- Providing consent to participants through detailed information, answering queries, assisting in obtaining signatures prior to any study related activities, documentation of process and provision of new and additional information as it arises throughout the study.
- Maintaining and managing documents essential for document maintenance during research in order to demonstrate compliance to applicable regulatory requirements and institutional policies.This management includes completion of all relevant logs and organised filing with ready access for relevant sponsor and regulatory representatives.
- Entering data into research databases including electronic databases/eCRFs to capture study related information as well as to clean data when queries are raised.
- Ensuring that specific protocol is followed and deviations minimized.
- Collecting biospecimen samples and diligently process these samples according to national and ICH-GCP standards and requirements.
Clinical trial management and co-ordination
Advice on ethical and regulatory submissions
Assistance with submission of ethical and regulatory documentation