Clinical Research Associate I

This advertisement does not meet the requirements for a Certificate of Sponsorship under Home Office regulations; therefore, the university will not be able to offer sponsorship for this role.

The KHP-CTO Quality Team was established in 2008 to manage the sponsor responsibilities for Clinical Trials of Investigational Medicinal Products (CTIMPs), as defined in the Medicines for Human Use (Clinical Trials) Regulations, for trials sponsored or co-sponsored by King's Health Partner Organisations. The team assists Chief Investigators with the set-up, initiation, maintenance and closure of their trials and ensures that these trials are established and conducted according to Good Clinical Practice (GCP) and the Regulations.,

• co-monitor and monitor CTIMP trials on behalf of the sponsor to ensure regulatory GCP compliance.



• To provide support to investigators conducting trials to ensure they are working to the highest quality standards and to monitor and report on the progress of trial sites across UK and some EU countries.



• To assist the Senior CRAs to ensure that investigators and their teams run the trial according to sponsor's SOPs, prevailing regulations and best research practice by providing advice, practical assistance and carrying out monitoring functions as appropriate.


This post will be offered on an indefinite contract

This is a full-time post - 100% full time equivalent

Key responsibilities

To assist the Senior CRAs, Quality Manager (QM) and R&D/Governance staff in the partner institutions to ensure that all trials are conducted in accordance with the Medicines for Human Use (Clinical Trial) Regulations 2004 (as amended) and the KHP-CTO SOPs.

• To assist the Quality Manager in the conduct of Regulatory Inspections and sponsor audits on behalf of the partner institutions.



• To provide timely written reports of monitoring activities.



• To maintain a working knowledge of prevailing regulations, guidance, best practices and clinical QA standards regarding the conduct of clinical trials.



• To ensure confidentiality of commercially sensitive information.



• To ensure data protection imperatives are respected.



• To undertake such other duties within the scope of the post as may be requested by the head of department.


To co-monitor and monitor clinical trials on behalf of the sponsor where one or more of the partner institutions is acting as sponsor. Monitoring is to be conducted according to Monitoring Plans agreed by the Sponsor institution and the Quality Manager. Activities to include:
Quality Control of data (Source Document Verification).
Documentation of protocol violations, adverse events and premature withdrawals.
Identification and resolution of problems: logistical, methodological, human and technical.
Detection and reporting of GCP deviations, finding and implementing corrective measures.
Ensuring timely adverse event reporting including reporting to regulatory authorities on behalf of the sponsor where one or more of the partner institutions is acting as sponsor.


• To maintain a working knowledge of prevailing regulations, guidance, best practices and clinical QA standards regarding the conduct of clinical trials.



• To provide advice on GCP and related matters to those wishing to conduct clinical trials across the partner institutions



• To assist the Senior CRAs and Quality Manager to promote a quality approach to the conduct of clinical trials to all staff involved in the administration and conduct of clinical trials across the partner institutions.



• Assisting the QM and Senior CRAs in collation of metrics and trial data.



• To lead and work flexibly as a member of a team.



• To assist the Clinical Trials Training Executive(s) in the education and training of clinical Investigator teams.
  
  Educated to at least A-level or degree level, preferably in a related subject area, e.g. a life science or clinical subject or relevant experience



• Sound working knowledge of the prevailing regulations and best research practices pertaining to the conduct of clinical trials, in particular GCP



• Strong planning and organizational skills including the ability to prioritize, manage multiple tasks and projects



• Strong interpersonal, communication, influential, and problem-solving skills including the ability to build successful relationships and collaborate in a cross-functional team and maintain a positive work environment



• Eye for detail and ability to accurately document findings in written reports



• Able to learn and work to SOPs and demonstrate a commitment to quality culture



• Strong computer skills (proficient with MS WORD, Excel and web-based applications).



• Highly motivated to learn new skills and an ability to take on new information quickly and effectively



• Willingness to travel including overnight stays



• A flexible, self-starter who is comfortable working with all levels of staff internally and externally.



• Initiative and a pro-active approach



• Desired Criteria:


• Monitoring of clinical trials to GCP



• Experience and knowledge of working within the NHS Research Governance Framework.