Clinical Trials Research Associate II (maternity cover)

The King’s Health Partners Clinical Trials Office is a collaboration between King’s College London, Guy’s & St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust and South London and Maudsley NHS Foundation Trust. It was set up to provide a single interface for those wishing to conduct clinical trials within the partner organisations, and to ensure that there are common, efficient processes for the set up and administration of clinical trials.

The post-holder will conduct clinical trial monitoring activities (including the initiation phase, routine phase, and close-out phase) of clinical trials sponsored or co-sponsored by King’s Health Partners (KHP) Partner Organisations: Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust, and South London and Maudsley NHS Foundation Trust. 

 

The post-holder will ensure adherence to approved protocols and undertake effective source data verification. 

 

The post-holder will ensure that all activities are conducted in accordance with applicable legislation, ICH GCP E6 guidelines, and applicable institutional policies. Working as part of the KHP-CTO Non-Commercial Team, the post-holder will ensure that the sponsor responsibilities (delegated to the KHP-CTO) for clinical oversight, safety reporting, and data integrity; are discharged to the highest standards of quality and compliance.

 

This is a 14-month fixed term maternity cover post. We’re looking for someone to start as soon as possible.

To be successful in this role, we are looking for candidates to have the following skills and experience:

 

 

1.      Educated to degree level in a health-related area or equivalent professional experience

2.      Significant experience of monitoring multi-centre clinical trials in accordance with GCP (including source data verification)

3.      Working knowledge of the regulations, guidance and codes of practice pertaining to the conduct of clinical trials

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

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

6.      Strong interpersonal skills, communication skills, influencing skills and problem-solving skills, including the ability to build rapport quickly and collaborate in a cross-functional team

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

8.      Willingness to travel, including overnight stays

 

 

1.      Experience supporting regulatory inspections, ideally by the MHRA

2.      Ability to ensure quality related issues are identified and followed up in a timely manner

3.      Experience with risk-based quality management systems

  

We pride ourselves on being inclusive and welcoming. We embrace diversity and want everyone to feel that they belong and are connected to others in our community.

 

We are committed to working with our staff and unions on these and other issues, to continue to support our people and to develop a diverse and inclusive culture at King's.

 

As part of this commitment to equality, diversity and inclusion and through this appointment process, it is our aim to develop candidate pools that include applicants from all backgrounds and communities.

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