You will be responsible for:
- Coordination and planning of budgets, people and time management
- Protocol evaluation and feasibility including budget evaluation
- Clinical trial preparation involving the planning, assembling and instruction of the trial team, development and evaluation of patient information and informed consent forms and patient recruitment
- Regulatory and ethical submissions and procedures and communicating with relevant authorities
- Implementation of the clinical trial from initiation through the stages of development documents, SOPs, tools, organization facilities and licenses
- Recruitment and co-ordination of the trial subjects covering informed consent, screening and inclusion of the subjects adhering to safety and compliance issues
- Co-ordination and management of the clinical trial, communication with sponsor and authorities, visit coordination, sampling, time management and product accountability
- Data collection and management, collection of source documents, using and developing CRFs, registration and management AEs, filing and archiving, managing monitoring visits, dealing with queries
- Close-out of the clinical trial, contributing to research article, audit preparation, trial closure, communication with authorities and other disciplines involved, assisting in the final study report and completing financial obligations.
- Make clinical and professional autonomous decisions on a daily basis.
- Provide clinical and professional advice relating to the conduct of clinical research to the multidisciplinary team.
- Analyze and assess each patients’ condition to establish the continuing care plan, appropriate action and future participation in the study in consultation with the treating doctor and/or the trial investigator.
- Act as a patient advocate at all times.
- In the absence of the Clinical Research Nurse Supervisor / Principal Investigator, make decisions on the use of research resources.
- Maintain a flexible approach to working hours in order to meet the requirements of the research protocols and subject recruitment.
- Responsible for analyzing patient status, managing patient care and ensuring excellent medical decision-making for all patients involved in clinical trials and, where relevant, their families, in partnership with all members of the multidisciplinary and research teams.
- The Clinical Research Nurse will be responsible for medical decision making to ensure the effective operation of individual clinical trials including patient recruitment and retention, patient safety, regulatory compliance, physician and staff interactions.
- The Clinical Research Nurse is not responsible for managing the budget but needs to be aware of the resources available and the need to remain within budget parameters.