Jemima Clarke – Research Coordinator

Jemima graduated from The University of Sheffield in 2002 having completed a dual honours degree in Biochemistry and Genetics. She worked as a Research Technician in the Bone Biology Group at Sheffield Children’s Hospital and then later at the University’s Medical School. From here she joined CellTran Ltd, a company specialising in regenerative wound healing. This involved growing autologous human tissue in a MHRA accredited Class 100 Cleanroom laboratory to treat burn victims and chronic wounds/ulcers in patients nationwide. The company worked to ISO9001:2000 standards and therefore Jemima gained much experience of Quality Management Systems. In her role she worked in accordance to Good Manufacturing Practice and had to ensure that her work and that of her colleagues was in compliance with the Human Tissue Act. She had also participated in several MHRA and HTA inspections.

Her role within the Unit is to ensure compliance to GCP. Jemima is responsible for projects in the post-governance set up phase of active and archived studies. This involves submitting study amendments for ethical review, maintaining the Investigators Site File and performing internal monitoring of studies. She is also involved in designing data collection forms and works alongside ScHARR to design and manage study databases. She is working with the Bone Biochemistry Laboratory to implement a Quality Management System. 

Email: jemima.clarke@sth.nhs.uk

Tel:  +44 (0)114 3052002

 
 

Additional Information

Role of the Research Governance team

Supporting the activities of the Researchers in both pre- and post-governance stages. Duties include:


• preparing and submitting new studies for ethical, competent authority and research governance approval; and submitting study amendments post-approval
• providing advice regarding planning new studies, protocol feasibility, liaising with support services to operationalise the study
• ensuring appropriate contracts and agreements are in place
• preparing study documentation (e.g. consent forms, health questionnaires, diaries, GP and participant letters)
• monitoring and auditing clinical trials
• maintaining study site files
• providing guidance to ensure that the Unit is compliant with UK clinical trials regulations, the Research Governance framework and ICH-GCP guidelines
• acting as a point of contact with the Research Department, Comprehensive Local Research Network (CLRN) and other external organisations

 

 

 

 

 
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