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Clinical Trial Administrator

£34,378 - £34,378
 

Job Description

We are looking for a highly organised and motivated Clinical Trials Administrator. You will be joining the Quality Team, who are a friendly team of Clinical Research Associates. The main purpose of this role is to:

  • Assist the Quality Team to ensure that all trials sponsored or co-sponsored by the partner organisations are conducted in accordance with the Clinical Trial Regulations and the KHP CTO SOPs.
  • Provide day to day admin and support to the Quality Team to assist Investigators conducting clinical trials sponsored by the partner institutions ensuring they are working to the highest quality standards.
  • Perform File Reviews and conduct archiving of trial documents for the KHP-CTO.
  • Provide logistical, practical and administrative support as required according to KHP-CTO SOPs, prevailing regulations and best research practice.

This is an office-based role at Guy?s Hospital with some regular travel across London to our various sites and campuses.



Qualifications

Educated to GCSE-level or equivalent



Skills
  1. Educated to GCSE-level or equivalent
  2. Able to learn and work to SOPs
  3. Strong planning and organisational skills including the ability to prioritise and manage multiple tasks
  4. Excellent interpersonal skills ? tactful and able to deal with a wide range of people in an enthusiastic and helpful manner whilst being capable of firmly maintaining policies and regulations.
  5. Problem solving skills ? pragmatic and flexible approach whilst maintaining policies and regulations.
  6. Strong computer skills (proficient with MS WORD, Excel and web-based applications).
  7. Experience acquired in administration role(s), preferably in either a pharmaceutical industry or clinical research setting, including specific experience of clinical trial administration.
  8. Excellent verbal and written communication skills with the ability to demonstrate exceptional attention to detail.

 

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I am looking for TWO GTAs to assist with running a respiratory practical for Pharmacy and Physiotherapy teaching. The dates and times are shown below:

Thursday 6th March 09:00-12:00 (Pharmacy)

Friday 7th March 09:00-11:00 (BSc Physiotherapy)

Tuesday 11th March 09:00-11:00 and 11:30-13:30 (MSc Physiotherapy)

The aims of this practical are

  1. To demonstrate the operation of the pneumotachograph, Vitalograph and Peak flow meter and their uses for measurement of lung volume and capacity 
  2. Use breath-holding and hyperventilation to illustrate the importance of CO2 to the control of breathing
    1. Explain why duration of breath-holding is affected by prior hyper-ventilation

After attending this practical, you should be able to

  1. Use a pneumotachograph to estimate tidal volume, inspiratory reserve volume, expiratory reserve volume, vital capacity, breathing rate and minute ventilation
  2. Use a Vitalograph to estimate vital capacity and calculate FEV1 and FER
  3. Use a peak flow meter to establish ventilatory peak flow

Please get in touch if you have any questions: james.2.clark@kcl.ac.uk



Qualifications

NONE



Skills

respiratory physiology, labchart

Key responsibilities   

  • To support the Lead Invigilator/ Staff Lead in carrying out their duties by attending briefing sessions prior to and following exam sessions as required.  
  • To assist with setting up the circuit(s): putting out clipboards, sharp pencils, and rubbers inside each station. 
  • Assist with the set-up of equipment (training will be given for the setting up of props or the resetting of station equipment). 
  • To assist students before the exam begins, ensuring that all students are correctly located and ready for the exam.   
  • To invigilate the examination circuits and guide students between stations during the exam.  
  • Direct examiners, patients, simulated patients to the correct stations. 
  • Be the first response for examiner questions or concerns, raising issues with the lead invigilator or senior examiner quickly and efficiently. 
  • To vigilantly monitor the room/allocated area throughout the exam in session whilst not disrupting the candidates; and ensuring a calm environment conducive to supporting students to be successful in their exams.  
  • To ensure that noise levels on the examination circuit are kept to a minimum and that examination conditions are maintained throughout 
  • To promptly report any incidents that may impact a candidate's performance to the Lead Invigilator, Circuit Lead (Marshall), OSCE Site Lead, or Senior Examiner. 
  • To ensure that, at the end of the exam, all iPads and materials are collected and returned to the relevant place according to set procedures as advised by the Lead Invigilator.   


Qualifications

N/a



Skills

Experience of Clinical Examination Invigilation

The post holder will primarily manage activities relating to the randomisation service and electronic data capture (EDC) system,  such as taking responsibility for user access and password management, data export, circulating documents for signature, receiving and processing Serious Adverse Event (SAE) forms relating to a portfolio of trials, reviewing the content of such notifications and processing them according to regulatory requirements, co-ordinating of King?s Trials Partnership activities and managing document version control and tracking within the KCTU.



Qualifications

Degree level qualification or equivalent professional experience (a subject with either a major health related component e.g. biology, psychology, or of relevance to administration e.g. accounting, business management, NHS management would be desirable



Skills

To act as the main point of contact for approximately 100 clinical trial teams currently using the KCTU randomisation service and electronic data capture system (EDC)

  • To process requests for user access to IT systems supporting the KCTU portfolio of trials accurately and promptly, with due care and attention
  • Manage activities relating to randomisation and EDC system, keeping accurate auditable records
  • To process Serious Adverse Event (SAE) reports in accordance with KCTU SOPs
  • Occasionally, to process Emergency Code Break notifications in accordance with KCTU SOPs
  • To receive and resolve queries relating to the above during the life of each project 
  • To provide administrative support to the King?s Clinical Trials Unit Operational Director and Business Manager along with other KCTU staff as needed
  • Manage activities of the KCTU in line with KCL policy and procedures and with the Standard Operating Procedures of the Clinical Trials Unit
  •  To participate in inspections of the KCTU by sponsor auditors, regulatory authorities and others, ensuring key documents are readily available
  • To ensure that the KCTU?s website is kept up to date and that the information is accurate
  • Responsible for providing a professional, accurate and efficient service to a wide range of people including study teams, colleagues and external agencies
  • Ensure compliance with GCP, regulatory legislation and ethical frameworks in respect of working practices
  • Liaise with a wide range of internal and external clients to ensure requests for user access to KCTU IT systems are processed swiftly, which will involve explaining complicated procedures on how to obtain access
  • Being mutually supportive and covering duties as necessary during colleagues absences and at time of additional pressure, as directed

 

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.

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