Operations Assistant (Clinical Trials)

Job id: 086625. Wage: £32,979 – £35,487 every year, together with London Weighting Allowance.

Posted: 22 March 2024. Time limit: 14 April 2024.

Enterprise unit: College of Life Sciences & Medication. Division: Complete Most cancers Centre.

Contact particulars:Thanussuyah Alaguthurai. [email protected]

Location: Guys Campus. Class: Skilled & Assist Companies.

Job description

Appearing as affected person and participant advocate always, the submit holder will probably be anticipated to co-ordinate analysis clinics and organise examine associated look after sufferers collaborating within the KCL Sponsored BTBC Examine at its varied examine analysis websites ( Chief Investigator Professor Andrew Tutt). They may determine methods to seek out and help within the enrolment of analysis members. The post-holder will consent sufferers and carry out a spread of medical assessments, and the place acceptable examine associated procedures reminiscent of phlebotomy for which they’re appropriately educated, consistent with accepted requirements of follow. They may talk successfully with the examine and medical groups to make sure good participant expertise and adherence to review protocols. The submit holder will probably be answerable for case report kind completion, website file administration and upkeep of databases. They are going to be answerable for ordering examine provides. The submit holder will make sure the well-being of members by adhering to related laws and native Normal Working Procedures (SOPs) together with Good Medical Observe (GCP), Medicines for Human Use (Medical Trials) Laws, Analysis Governance Framework for Well being and Social Care and the Human Tissue Act.

This submit will probably be provided on a fixed-term contract for two years.

It is a full-time  submit – 100% full time equal.

Key duties

• Present wonderful buyer care expertise to make sure sufferers and members come first.  
• Work inside related laws and ICH GCP (Worldwide Convention on Harmonisation and Good Medical Observe) guaranteeing that the examine protocol is adhered to always. 
• Set up methods for recruiting members into medical research and determine people doubtlessly eligible for analysis research. Acquire permissions for analysis contacts.
• Co-ordinate analysis clinics and co-ordinate the exercise in Professor Tutt’s translational analysis research along side Ms Thanussuyah Alaguthurai (Senior medical Analysis Practitioner) and different staff members.
• For particular research submit holder could also be delegated to acquire consent from members consistent with Belief coverage and analysis protocol. 
• Organise appointments and conduct phone follow-up calls as required. 
• Report any adversarial occasions or well being considerations which happen while the participant is collaborating within the examine, to an acceptable physician or nurse in a well timed method and to the suitable principal or co-investigator.  
• Carry out and document a spread of medical assessments consistent with private competencies and as stipulated in accredited examine protocols together with blood stress, temperature, respirations, questionnaires, urinalysis, weight and peak, and report abnormalities or modifications appropriately. 
• Carry out duties requiring medical and laboratory expertise, together with phlebotomy, venepuncture, organic pattern preparation inside medical space and laboratories as stipulated in accredited protocols and laboratory manuals.  
• Chargeable for guaranteeing protected and acceptable storage, cargo and documentation of specimens. 
• Hold updated with present follow for phlebotomy and venepuncture. 
• Present ongoing help to the participant and carer while taking part within the medical examine. 
• Talk regularly with senior medical employees, nursing, pharmacy, radiology, and pathology and laboratory employees.  
• Liaise with different departments and wards on the website/s, so as to promote working setting, integration of analysis and open channels of communication. 
• Take duty for guaranteeing personal information of amendments and updates to research you’re employed on and help the analysis staff in guaranteeing that data referring to updates within the examine protocols and pointers are disseminated to key areas and personnel. 
• Talk examine associated data successfully with the analysis staff and examine members and their relations. This data could also be complicated or delicate, and there could also be limitations to understanding.  
• Talk with exterior examine coordinators and sponsor representatives, nationally and internationally. 
• Ship GP letters or different trial associated materials to related events. 
• Prepare, attend and document minutes for analysis and different related departmental assembly. 
• Help with the organisation and arrange of choice and initiation and investigator conferences for research. 
• Attend nationwide and worldwide examine particular conferences and disseminate data to members of the multi-disciplinary staff as required. 
• Replace participant examine and medical information to precisely doc examine associated exercise and procedures. 
• Administration and upkeep of trial website information in coordination with sponsor representatives. 
• Make sure the confidentiality of verbal, written and computerised data.  
• Full case report kinds in a exact and well timed method, guaranteeing that each one the related medical information within the affected person’s medical notes and examine file is transcribed precisely. 
• Chargeable for the upkeep of Investigator Web site Information.  
• Create databases, validate and preserve them and guarantee their safety and compliance with the information safety act. 
• Replace and preserve centralised affected person database. 
• Deal successfully with queries referring to information and data in a well timed and environment friendly method. 
• Help within the creation and upkeep of excellent workplace methods for the sleek operating of the service. 
• Organise and put together documentation for monitoring visits. 
• Present well timed data and reviews to replicate recruitment of sufferers together with well timed entry to EDGE based on staff processes. 
• Escalate any points concerning information assortment to the suitable personnel.  
• Help sponsor and/or R&D with related important paperwork at arrange of a examine. 
• Help in archiving processes for closed research throughout the staff. 
• Present recommendation and coaching to colleagues as related to your position. 
• Supervise, prepare or mentor new or extra junior employees as required. 
• Take duty for figuring out private coaching and academic wants throughout the context of the service and people recognized through the appraisal course of. 
• Act in accordance with the Well being Training England (HEE) Care Certificates framework requirements always. 
• Undertake an Particular person Efficiency Evaluation yearly along with your Line Supervisor. 
• Help different members of the multidisciplinary staff as required with all points of examine supply. 
• Act all the time in a fashion which, promotes constructive working relationships and maintains the skilled picture of the Belief.  
• Co-ordinate and supervise housekeeping duties and ordering of examine provides as requested. 
• Responsibly help within the administration the management of apparatus, sources and inventory via the adherence of analysis insurance policies and examine budgets. 
• Guarantee personal actions assist to take care of high quality.
• To work as a member of a multi-disciplinary staff 
• Work collaboratively with colleagues throughout R&D, NIHR Man’s and St Thomas’ BRC and wider Belief to facilitate the achievement of aims and shared studying.

The above record of duties might not be exhaustive, and the submit holder will probably be required to undertake such duties and duties as could moderately be anticipated throughout the scope and grading of the submit.

Abilities, information, and expertise

Important standards  

NVQ stage 4 or equal qualification or certified to NVQ3 or equal plus vital earlier expertise  

Expertise of working in a healthcare or medical analysis position with affected person/public communication/ coordination duties OR biomedical diploma and expertise working in a public going through position 

Expertise of working in a staff 

Skill to speak effectively (written and verbally), with clear and legible handwriting 

In a position to work in a multidisciplinary staff and on personal initiative 

Skill to co-ordinate assortment of knowledge to agreed timescales 

Skill to co-ordinate participant visits with multidisciplinary staff 

Skill to grasp and adjust to analysis protocols and departmental procedures and report difficulties and exceptions to senior employees 

Skill to handle priorities beneath stress 

In a position to conduct medical duties reminiscent of blood stress, temperature, pulse and respiratory observations. 

Skill to develop expertise required by analysis protocols for instance phlebotomy and pattern assortment and fundamental laboratory expertise  

Skill to accumulate fundamental laboratory expertise. 

Fascinating standards

Proof of training associated to medical analysis 

Good Medical Observe coaching  

Expertise of caring for sufferers/members in an expert setting. 

Expertise of engaged on medical trials of medication, therapies or interventions. 

Information of necessary requirements for medical analysis conduct (together with GCP, UK Coverage framework for Well being and Social Care analysis, information safety) 

This submit is topic to Disclosure and Barring Service and Occupational Well being clearance.