The post of the Clinical Research Assistant will provide comprehensive support for a newly started clinical trial in Rett Syndrome (RTT) at the NIHR Wellcome Trust Clinical Research Facility (CRF) at King’s College Hospital. This post offers an exciting opportunity for someone with excellent communication, research and record keeping skills who wants to be part of an experienced team leading a multi-center clinical trial in patients with RTT.
The post holder will be working within a team of clinicians, scientists and research nurses under the supervision of the Chief Investigator Professor Paramala Santosh. The successful candidate will serve as the primary point of contact for the clinical trial ensuring that the trial adheres to the GCP guidelines, Standard Operating Procedures and University policies and procedures. The post-holder will be responsible for contacting parents/carers of patients deemed suitable for the trial and to coordinate study visits and preparing documentation needed for study visits. The post-holder will also have the opportunity to develop their data entry skills and the interpretation of results.
Experience of phlebotomy (or a willingness to undertake a phlebotomy course) is an essential part of the role in order to support the Study Physician with ongoing duties. The post-holder must also ensure that the Site File is maintained and be responsible for the resolution of monitor queries after consultation with the Chief Investigator and Study Physician. This can also include disseminating any changes to the Clinical Trial Protocol to relevant members of the trial team and making sure delegation logs are kept updated. The post-holder is also expected to provide support to other research staff when needed.
This post will be offered on a fixed-term contract for 12 months in the first instance.
This is a full-time post – 100% full time equivalent
- Maintenance of clinical trial documentation, review and updating of necessary regulatory documents and coordinating effectively with the Chief Investigator.
- With other team members identify and consent participants for the trial.
- Contribute to the implementation of Research Ethics and R&D applications and dissemination any protocol amendments to relevant team members.
- Highlight any problems with delivery of the clinical trial to the Chief Investigator and sub-investigators.
- To monitor clinical trial paperwork and all necessary documentation following patient recruitment.
- Ensure that all documentation required by the funder, university and NHS, including ethics and R&D approvals, are completed in a timely manner.
- Measuring adherence to the Clinical Trial Protocol, data monitoring and GCP guidelines, and communicating procedural conformance to the Chief Investigator.
- Work collaboratively with all members of the clinical trial team
- Ensuring timely and accurate data entry and data backup is achieved, by working with other team members.
Skills, knowledge, and experience
- Good degree relevant discipline, or equivalent experience
- Experience of study co-ordination in Industry/NHS or Academia
- GCP Certificate
- Experience in phlebotomy (or a willingness to undertake a phlebotomy course)
- Knowledge of clinical trials and regulations
- Familiarity with the use of databases for clinical trials and strong data handling skills
- Good organisational skills for coordinating and maintaining timely regulatory and ethics reports
- Be empathetic to study participants, their families and other persons involved in the clinical trial
- Excellent communication skills
- Enhanced DBS clearance
- Experience of working as part of a research team
- Experience of psychiatric assessment of young people with mental illness
- Clinical or research work with adolescents and adults