Clinical Research Associate II (set-up specialist)

Job description

The King’s Health Partners Clinical Trials Office (KHP-CTO) is a joint initiative between the member institutions of King’s Health Partners. It was set up to provide a single interface for those wishing to conduct clinical trials within the partner institutions, and to ensure that there are common, efficient processes for the set up and administration of clinical trials. http://www.khpcto.co.uk

 

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.

 

We are looking for someone experienced to take the lead in setting up trials sponsored by KHP Organisations. The successful applicant will be required to review protocols for GCP and operational compliance and take teams forward to application and initiation. The ideal applicant will also have experience of working independently with sites, performing source data verification and monitoring trials to GCP, as some site visits may be required.

 

The post holder will be required to:

• Set up, initiate and on occasion monitor and close clinical trials on behalf of the sponsor where one or more of the partner institutions is acting as sponsor, to ensure regulatory compliance.

• Provide support to investigators conducting clinical trials sponsored by partner institutions to ensure they are set up and working to the highest quality standards and report on the progress of trials.

• Ensure that investigators and their teams set up and, where applicable, run trials according to sponsor’s SOPs, prevailing regulations and best research practice by providing advice, practical assistance and carrying out set-up and monitoring functions as appropriate.

 

If you are an experienced CRA, we would like to hear from you.

 

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.

 

This post will be offered on an indefinite contract

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

 

Key responsibilities

• To assist the Quality Manager (QM) and R&D staff in the partner institutions to ensure that all trials sponsored or co-sponsored by the partner organisations are set up and conducted in accordance with the current UK and EU Clinical Trial legislations and the KHP-CTO SOPs.
• To ensure that development safety update reports, pharmacovigilance reports and protocol amendments are submitted to MHRA, thereby maintaining Clinical Trial Authorisations
• To set up, initiate and occasionally monitor and close clinical trials on behalf of the sponsor where one or more of the partner institutions is acting as sponsor. Activities to include:

o   Review of protocols in set-up to ensure they align with regulatory and sponsor requirements.

o   Completion of Clinical Trial Application processes in conjunction with trial teams to ensure high-quality, regulatory-compliant applications.

o   Close liaison with KHP Partner Research Governance Offices and contract teams to facilitate trial progress ensuring requirements being met.

o   Initiation of trials once approvals obtained.

o   Review of trial progress and reporting to the sponsor.

o   Quality control of data (Source Document Verification), if required.

o   Documentation of protocol violations/deviations, adverse events and premature withdrawals, if required.

o   Identification and resolution of problems: logistical, methodological, human and technical.

o   Management of trial related logistics.

o   Detection and reporting of GCP deviations, finding and implementing corrective measures.

o   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.

o   Documenting and tracking communication with trial sites.

• To assist the QM in the conduct of regulatory inspections and sponsor audits for both commercially sponsored and non-commercially sponsored trials on behalf of the partner institutions.
• 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 promote a quality approach to the conduct of clinical trials and act as an ambassador for the KHP-CTO
• This post is field based national and international travel on occasion including overnight stays

The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.

Skills, knowledge, and experience

Essential criteria

1.       Significant experience of setting up and monitoring of clinical trials to GCP (including source data verification) OR significant experience in CTIMP trial management of multi-centre studies; in a pharmaceutical company, contract research organisation, NHS or academic setting

2.       Educated to “A” level or degree level, preferably in a related subject area, e.g. a life science or clinical subject

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

4.       Strong planning and organisational skills including the ability to prioritise, manage multiple tasks and projects, with proven ability to deliver to stringent performance criteria.

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

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

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

8.       Able to learn and work to SOPs and demonstrate a commitment to quality culture

9.       Willingness to travel nationally and internationally on occasion, including occasional overnight stays

 

Desirable criteria

1.       Experience across a range of therapeutic areas

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

3.       Experience of setting up clinical trials within the NHS/academic sector or within a pharmaceutical company

4.       Ability to understand and function in the different cultural environments of clinical research