JOB SUMMARY

The research team at the Fetal Medicine Research Institute at Kings College Hospital has an extensive portfolio covering a range of studies from observational cohort studies to interventional trials for the prediction and prevention of pregnancy complications; and has developed a reputation for excellence in research delivery. An opportunity has arisen for a band 4 research assistant to join the team, initially for 12 months, subject to review.
The post holder will be part of the team of research fellows and co-ordinators working to deliver the research studies within the portfolio, in accordance with the principles of Good Clinical Practice (GCP). This will include important trials with an international profile that are both challenging and interesting. The post holder will manage the research database for patients entering the cf-DNA and STATIN studies but also databases for other research studies in the future. The post holder will ensure clinic appointments/tests required for patients involved in trials are carried out according to the schedule in the protocol – this will include communicating with research participants via telephone.
The successful applicant will have excellent communication skills and a willingness to learn new skills. There is significant patient interaction and a soothing, approachable manner is desirable. For this post you must demonstrate the ability to manage your own work load with supervision from clinical staff; understand clinical trial activity and GCP and be able to complete trial documentation accurately and in a timely manner after.

GENERIC STATEMENTS FOR INCLUSION IN ALL JOB DESCRIPTIONS:

1. The post holder has a general duty of care for their own health, safety and well being and that of work colleagues, visitors and patients within the hospital, in addition to any specific risk management or clinical governance accountabilities associated with this post.

2. To observe the rules, policies, procedures and standards of King’s College Hospital NHS Trust together with all relevant statutory and professional obligations.

• To observe and maintain strict confidentiality of personal information relating to patients and staff.

1. To be responsible, with management support, for their own personal development and to actively contribute to the development of colleagues.

• The post holder has an important responsibility for and contribution to infection control and must be familiar with the infection control and hygiene requirements of this role.
• These requirements are set out in the National Code of Practice on Infection Control and in local policies and procedures which will be made clear during your induction and subsequent refresher training. These standards must be strictly complied with at all times.

1. This job description is intended as a guide to the general scope of duties and is not intended to be definitive or restrictive. It is expected that some of the duties will change over time and this description will be subject to review in consultation with the post holder.
   This job description covers the core responsibilities of the job role. It may be necessary in order to meet the needs of the service, for management to assign other reasonable duties. Any significant changes will be discussed with the post holder in accordance with the Trust’s HR policy.

QUALIFICATIONS & EDUCATION

Essential
1. ‘A’ Level or equivalent Supplemented by either a diploma, formal training or equivalent experience
2. Evidence of continuing professional development.
1. Degree/ Higher education or equivalent
2. Experience of clinical research.
3. IT related qualifications 4. ICH GCP Trained
Further knowledge, experience and skills
1. Good organisational skills
2. Able to prioritise, problem solve and meet deadlines
3. Able to organize own workload
4. Good IT skills, competent in Excel
5. Excellent communication skills
6. Good attention to detail
7. Administrative experience
8. Experience of dealing directly with patients
9. Experience of data management
10. Advanced keyboard skills.
1. Evidence of an interest and understanding of a research assistant’s role.
2. Clinical research experience
3. Previous NHS or other healthcare environment experience
4. ICH GCP training
5. Awareness of current legislation regarding research governance issues
6. Phlebotomy experience
Aptitude
1. Enthusiastic and able to motivate self and others
2. Ability to work using own initiative, in a flexible atmosphere without close supervision
3. Ability to prioritise work within fast changing environment and meet deadlines
4. Ability to work without supervision and use own initiative
5. Attention to detail
6. Good organisational skills
7. Ability to work as part of a team
8. Clear verbal communication
9. Ability to communicate with wide range of people and demonstrate customer care skills
1. Ability to work effectively in a multi-disciplinary setting.
Job Type: Full-time
Pay: From £25,000.00 per year

Schedule:

• 8 hour shift

Work Location: In person
Reference ID: FMF31032

ROLE SUMMARY:

• To work closely with the Study project teams in all phases of the studies.
• To keep the study co-ordinators and principal investigators updated, and to report and record any deviations from the study protocol.
• To complete relevant paper and electronic trial documentation as required.
• Maintaining all studies documentation in good order and in accordance with the requirements of research governance.
• To work within GCP guidelines.
• To take blood samples for relevant studies

MAIN TASKS: CLINICAL PRACTICE & RESEARCH

• Assist and support research midwives and fellows with accurate completion of trial paperwork. Including; transcribing/exporting data from medical records/GP Surgery/ IT systems to Case Report Forms (CRFs) (paper or electronic) as required by clinical trial protocols, checking eligibility of patients for entry into trials and randomising/registering patients into trials according to protocol requirements.
• Ensure clinic appointments/tests required for patients involved in trials are carried out according to the schedule in the protocol.
• Assist with clinical observations as required by study protocol under the supervision (or direction) of qualified staff and participate in the care of adults requiring a range of clinical interventions, which may include venesection, obtaining blood pressure (electronic), and measuring height and weight (anthropometric measurements). Training will be provided where necessary.
• Responsible for organising a large amount of consent forms arising from the studies, ensuring accurate documentation
• Responsible for ordering consumables needed for the research studies
• Provide general administrative support including filing, fielding telephone calls, ordering patient notes, retrieving patient test results via hospital IT systems and arrange meeting dates, times and venues as directed by management.
• Update the trials databases including EDGE with details of patients screened and recruited to trials/research. Training will be provided where necessary.
• Support the team in preparing documentation for monitoring visits including electronic ordering of medical records, arranging suitable meeting rooms and act as a liaison when monitors are on-site.

PROFESSIONAL RESPONSIBILITIES:

• To observe general rules, policies, procedures and standards of King’s College Hospital NHS Trust together with all relevant statutory and professional obligations
• To work in accordance with the research governance and English Law regulations relating to research activity.
• To communicate effectively with the research team and the wider multi-professional health care team.
• To ensure that patient and staff confidentiality is maintained and guaranteed at all times within the terms of the data protection act.
• To report any significant problems encountered with the research to the relevant midwife/ fellow.
• Be aware of, and comply with, all Trust infection prevention and control policies, to include hand hygiene, personal hygiene, environmental and food hygiene. To undertake annual training/updates in infection prevention and control
• The post holder has a general duty of care for their own health, safety and well being and that of work colleagues, visitors and patients within the hospital, in addition to any specific risk management or clinical governance accountabilities associated with this post.
• To observe the rules, policies, procedures and standards of King’s College Hospital NHS Foundation Trust together with all relevant statutory and professional obligations.
• To be responsible, with management support, for their own personal development and to actively contribute to the development of colleagues.
• To liaise with outside research agencies such as CRN, funders.

RESEARCH RESPONSIBILITIES:

1. To maintain comprehensive and accurate and records in accordance with departmental policy and to ensure the safekeeping and confidentiality of these records.

2. Ensure all data required by other relevant and associated bodies is collected as required.

• To be an active team member of the research team by supporting other members, offering assistance and being flexible and approachable.
• To assist with general promotion and improvement of research activity within the Fetal Medicine department.

At all times, to protect the rights and the safety of patients, and to report any issues to the line manager.

EDUCATION RESPONSIBILITIES:

1. Undertake in-house training, updates, training days or courses relevant to the role, e.g. GCP.
2. Undertake appropriate trust mandatory update training e.g. moving and handling, basic life support (if needed), fire safety and awareness, and Health and Safety.