Associate Clinical Research Practitioner

Collection of patient data from medical notes and completion of case record forms (CRFs) and to liaise with clinical trial co-ordinators, research nurses and investigators to ensure accurate data collection To transcribe/export data from medical records (paper or electronic) to CRFs (paper or electronic) as required by the study protocol Facilitate the secure filing and storage of study documentation in accordance with ICH- GCP and Research Governance and conduct quality assurance of documentation Organise and prepare for visits by trial monitors as required by the study protocol Take responsibility for liaising with clinical trials units/study sponsors regarding data queries and for checking and resolving data queries To evaluate patient eligibility, in liaison with other appropriate health care professionals for clinical trial entry, involving coordination of pre study tests, obtaining results and arranging appropriate appointments as per clinical trial protocols.

Have a solid understanding of the application of ICH GCP Guidelines, the EU Directive on Clinical Research and Research Governance To ensure patients / carers are provided with written information relevant to the research study and are given the opportunity to discuss the research study or clinical trial adequately at the outset and during the course of the research or clinical trial in which they are being asked to participate (i.e. informed consent) Attend and support patients in the clinical environment for monitoring, assessment and follow up as part of research projects Where appropriate, to take consent from patients/participants to enter research studies To take relevant patient samples for clinical trials; such as blood samples, to centrifuge and separate serum, package and dispatch as per defined protocols, where appropriate Observe patients and monitor treatment toxicity/side effects; escalating findings accordingly Maintain accurate patient trial documentation, complete Case Record Forms, including the use of electronic data capture systems and ensure relevant information is recorded in patients medical notes Ensure safety data is reported to required SOPs and study protocols, and reports sent in a timely manner To ensure safe and appropriate storage of specimens in accordance with the trial protocol and in conjunction with specialist teams To record and report any adverse and serious adverse events according to trial protocol and local procedure.

As a new post holder, training will be provided for the key aspects of this role, and a period of induction identified, however, the post holder will be expected to take advantage of opportunities to upgrade their skills and to attend meetings and workshops to enhance their knowledge.