Job summary
An exciting opportunity has risen for a dynamic individual with experience in clinical research delivery to join our enthusiastic research team within the NIHR Clinical research Facility, Cancer Research Team and work with a breast cancer screening portfolio (Prospects Study). The post holder will play a key role in developing and creating robust systems and processes to enable the allocated study to run smoothly and efficiently.
The Clinical Research Coordinator (CRC) will be responsible for coordinating the study whilst supporting the research nurses and investigators in the delivery process. The role will involve working closely with the Principal Investigators, cancer research team, sponsor, clinical nurse specialists, breast radiology team, Southwest London breast screening programme team and the Joint Research and Enterprise Service. The post holder will foster excellent communication and working relationships with the all clinical research delivery professionals internally and externally. The post holder will need to be dynamic, able to work well under pressure and cope with conflicting demands whilst maintaining excellent organisational, communication and IT skills. Confidentiality, accuracy and attention to detail are fundamental for this position.
We are very keen to speak to potential applicants for the post and would be very supportive of applicants contacting us either by email or telephone.
Main duties of the job
Support the Trust and University clinical research agenda assisting in the clinical research studies undertaken in or associated with the Cancer Research, SWLBSS/Breast Radiology and PROSPECTS study
To support the research team in all aspects of administration and governance related to relevant research studies Carry out responsibilities that are related to the day to day running of clinical trials to ensure quality is maintained. The post holder will work across clinical research studies within the Unit. The post holder must also be willing to move to a different clinical specialty where the need to do so is identified.
About us
Trust Vision & Values:
The postholder is expected to have a clear understanding of how this post contributes to the achievement of the trust vision of:
We are a thriving Foundation Trust at the heart of an integrated healthcare system. One that delivers improved patient care at a community, hospital and specialist setting, supported by a unique and nationally recognised programme of research, education and employee engagement.
We expect all our staff to share the values that are important to the Trust, being Excellent, Kind, Responsible & Respectful, and behave in a way that reflects these.
St George's University Hospitals NHS Foundation Trust is committed to safeguarding children and vulnerable adults and expects that all staff will share in this commitment. The Trust is clear that all staff have a responsibility to be aware of children and adult safeguarding policies and proceduresand that each member of staff, clinical and non-clinical, will attend child or adult safeguarding training that is provided at an appropriate level to suit their role. The Trust has the additional expectation that all staff will be able to identify concerns and know what action to take.
Job description
Job responsibilities
Administration:
- Initiate and manage the day to day running of allocated trials in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs)
- To Assist in the completion of applications to the Health Research Authority (HRA) , Research Ethics Committees (REC), Medicines and Healthcare products Regulatory Agency (MHRA) and the Joint Research & Enterprise Serivce (JRES) for new research proposals .
- Ensuring that trials do not commence until all regulatory, sponsor and local JRES/R&D requirements are satisfied.
- Ensure trial specific responsibilities delegated by the Sponsor to the PI are carried out in accordance with the specific contract. Ensure that this correlates to the information recorded on the delegation log and is accordance with protocol guidance.
- Responsible for correct version control of all documentation. Prepare and submit amendments, as required and update trial documentation as necessary e.g. protocols, investigator brochures, case report forms. Ensure all allocated Site Files are ready to be reviewed by study teams and regulatory bodies. Ensure that electronic and paper documents are stored appropriately and are easily accessible by the team.
- Work closely with clinical teams to aid liaisons between research and clinical teams for effective communications.
- Responsible for ensuring CRFs (Case Report Forms) both paper and electronic, are accurately completed in a timely manner. Ensure that confidentiality is maintained and adhere to the Data Protection Act. Within the allocated portfolio the post holder will work independently on several studies.
- Ensure that high quality is maintained, by demonstrating minimum data query requests. Take action to complete missing data as required and ensure efficient procedures are in place to improve data capture. Able to discuss concerns with the Senior Research Nurse/Practitioner, Programme Manager and implement changes to improve quality.
- Be the main point of contact with JRES (sponsor), ensure that communication is cascaded to the team and the Principal Investigator, and facilitate any actions required. Including updating the MDT on trial activity to ensure that invoices are raised and relevant departments are cross charged. Draft progress reports to REC, R&D, funders, sponsors and regulatory bodies as appropriate.
Research practice:
- To deal sensitively and in a professional manner with patients in person and on the telephone when dealing with queries and booking appointments.
- To perform observations e.g. temperature, pulse, blood pressure, respiration, urine testing, height & weight and to record these correctly in the patients records, reporting any abnormality or change in these to the research Nurse.
- Once fully trained and competent to take consent, perform venepuncture and process (centrifuging and sending to internal and external labs) clinical specimens, including blood and urine as per protocol requirements.
- Ensure the collection, processing, storage and use of human tissue is carried out according to protocol requirements and in accordance with local SOPs and the Human Tissue Act
- To adhere to the recommendations for the Control of Substances Hazardous to Health (COSHH) and risk assessments appropriate to the clinical area.
- To have responsibility for the Health, Safety and Welfare of self and others and to comply at all times with the requirement of the Health and Safety Regulations.
General:
- To have responsibility for the Health, Safety and Welfare of self and others and to comply at all times with the requirement of the Health and Safety Regulations.
Job description
Job responsibilities
Administration:
- Initiate and manage the day to day running of allocated trials in accordance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs)
- To Assist in the completion of applications to the Health Research Authority (HRA) , Research Ethics Committees (REC), Medicines and Healthcare products Regulatory Agency (MHRA) and the Joint Research & Enterprise Serivce (JRES) for new research proposals .
- Ensuring that trials do not commence until all regulatory, sponsor and local JRES/R&D requirements are satisfied.
- Ensure trial specific responsibilities delegated by the Sponsor to the PI are carried out in accordance with the specific contract. Ensure that this correlates to the information recorded on the delegation log and is accordance with protocol guidance.
- Responsible for correct version control of all documentation. Prepare and submit amendments, as required and update trial documentation as necessary e.g. protocols, investigator brochures, case report forms. Ensure all allocated Site Files are ready to be reviewed by study teams and regulatory bodies. Ensure that electronic and paper documents are stored appropriately and are easily accessible by the team.
- Work closely with clinical teams to aid liaisons between research and clinical teams for effective communications.
- Responsible for ensuring CRFs (Case Report Forms) both paper and electronic, are accurately completed in a timely manner. Ensure that confidentiality is maintained and adhere to the Data Protection Act. Within the allocated portfolio the post holder will work independently on several studies.
- Ensure that high quality is maintained, by demonstrating minimum data query requests. Take action to complete missing data as required and ensure efficient procedures are in place to improve data capture. Able to discuss concerns with the Senior Research Nurse/Practitioner, Programme Manager and implement changes to improve quality.
- Be the main point of contact with JRES (sponsor), ensure that communication is cascaded to the team and the Principal Investigator, and facilitate any actions required. Including updating the MDT on trial activity to ensure that invoices are raised and relevant departments are cross charged. Draft progress reports to REC, R&D, funders, sponsors and regulatory bodies as appropriate.
Research practice:
- To deal sensitively and in a professional manner with patients in person and on the telephone when dealing with queries and booking appointments.
- To perform observations e.g. temperature, pulse, blood pressure, respiration, urine testing, height & weight and to record these correctly in the patients records, reporting any abnormality or change in these to the research Nurse.
- Once fully trained and competent to take consent, perform venepuncture and process (centrifuging and sending to internal and external labs) clinical specimens, including blood and urine as per protocol requirements.
- Ensure the collection, processing, storage and use of human tissue is carried out according to protocol requirements and in accordance with local SOPs and the Human Tissue Act
- To adhere to the recommendations for the Control of Substances Hazardous to Health (COSHH) and risk assessments appropriate to the clinical area.
- To have responsibility for the Health, Safety and Welfare of self and others and to comply at all times with the requirement of the Health and Safety Regulations.
General:
- To have responsibility for the Health, Safety and Welfare of self and others and to comply at all times with the requirement of the Health and Safety Regulations.
Person Specification
Knowledge
Essential
- Understanding of clinical trials and regulation governing clinical research.
- Medical terminology
- Flexible and Dynamic
Skills and Abilities
Essential
- Excellent organisation skills.
- Excellent oral and written communication skills.
- Excellent attention to detail.
- Excellent IT skills including access excel and power point.
- Ability to communicate with patients in a sympathetic and efficient manner.
- Good time management.
- Able to work under pressure.
Desirable
- Phlebotomy
- Experiences in project management
- Experience of Clinical Laboratory work (i.e. Spinning and aliquoting blood samples)
- Experience of working with Research Governance policies and issues
- Experience in undertaking medical /Clinical Research
Experience
Essential
- Experience working in a clinical Trial setting or equivalent experience
- Experience of data entry and data management in clinical trials or equivalent experience
- Experience dealing with the general public
- Experience working in a team on joint projects.
Desirable
- Experience within the NHS
- Teaching or training experience
Qualification
Essential
- Life sciences degree, or equivalent experience
Desirable
- Recent GCP training or qualification in research/clinical trials
Person Specification
Knowledge
Essential
- Understanding of clinical trials and regulation governing clinical research.
- Medical terminology
- Flexible and Dynamic
Skills and Abilities
Essential
- Excellent organisation skills.
- Excellent oral and written communication skills.
- Excellent attention to detail.
- Excellent IT skills including access excel and power point.
- Ability to communicate with patients in a sympathetic and efficient manner.
- Good time management.
- Able to work under pressure.
Desirable
- Phlebotomy
- Experiences in project management
- Experience of Clinical Laboratory work (i.e. Spinning and aliquoting blood samples)
- Experience of working with Research Governance policies and issues
- Experience in undertaking medical /Clinical Research
Experience
Essential
- Experience working in a clinical Trial setting or equivalent experience
- Experience of data entry and data management in clinical trials or equivalent experience
- Experience dealing with the general public
- Experience working in a team on joint projects.
Desirable
- Experience within the NHS
- Teaching or training experience
Qualification
Essential
- Life sciences degree, or equivalent experience
Desirable
- Recent GCP training or qualification in research/clinical trials
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
