Clinical Trials Clerk

Job summary

An exciting opportunity has arisen for an enthusiastic individual to join the Experimental Cancer Medicine Team at The Christie NHS Foundation Trust. The Clinical Trials Clerk will join an established Trials Administration function and will be involved in various administrative support tasks to provide a high quality clerical and administrative service.

We are looking for a candidate with previous administrative/ clerical experience, good organisation and communication skills; who can work well both in a team and using their own initiative.

The Christie NHS Foundation Trust is one of the largest cancer treatment centres in Europe, and an international leader in cancer research and development. We are one of the leading centres in the UK for clinical trials and radiotherapy research. In 2010, we also opened our new patient treatment centre, the largest clinical trials unit of its kind at present. Through this development, we aspire to put Manchester at the forefront of international research.

Main duties of the job

The post holder will assist with the following clerical and administrative duties:

1. Assist in the filing of clinical trial documentation in investigator site files in accordance with ICH-GCP and Trust SOPs.
2. Assist in completing team reports (i.e. recruitment activity logs, patient visit logs, case report form trackers and electronic proformas).
3. Ensure collection, tracking and general organisation of clinical case notes for all patients, so that these are available as needed for monitoring and audit purposes.
4. General assistance with preparation for monitoring visits and follow up actions under supervision.
5. Photocopying and internal delivery/ transfer of clinical trial/ miscellaneous documentation (i.e. case report forms, contracts, trial set-up documentation, copies of scans).
6. Liaise with internal and external NHS staff regarding case notes, data collection (i.e. discharge summaries), archival tumour block requests (under supervision for retrospective block requests only), mortality data, and other general trial activities, which may be confidential and sensitive in nature.
7. Booking seminar rooms for team, trial related and other miscellaneous meetings, producing minutes in a timely manner if required.
8. Assist with trial document archiving by following the Trust's archiving guidelines under supervision.
9. Ensure that office supplies are adequate and assist with the ordering process.

About us

The Christie is one of Europe's leading cancer centres, treating over 60,000 patients a year. We are based in Manchester and serve a population of 3.2 million across Greater Manchester & Cheshire, but as a national specialist around 15% patients are referred to us from other parts of the country.

We provide radiotherapy through one of the largest radiotherapy departments in the world; chemotherapy on site and through 14 other hospitals; highly specialist surgery for complex and rare cancer; and a wide range of support and diagnostic services. We are also an international leader in research, with world first breakthroughs for over 100 years.

We run one of the largest early clinical trial units in Europe with over 300 trials every year. Cancer research in Manchester, most of which is undertaken on the Christie site, has been officially ranked the best in the UK.

Job description

Job responsibilities

DUTIES AND RESPONSIBILITIES

1. Assist in the filing of clinical trial documentation in investigator site files in accordance with ICH-GCP and Trust SOPs.
2. Assist in completing team reports (i.e. recruitment activity logs, patient visit logs, case report form trackers and electronic proformas).
3. Ensure collection, tracking and general organisation of clinical case notes for all patients, so that these are available as needed for monitoring and audit purposes.
4. General assistance with preparation for monitoring visits and follow up actions under supervision.
5. Photocopying and internal delivery/ transfer of clinical trial/ miscellaneous documentation (i.e. case report forms, contracts, trial set-up documentation, copies of scans).
6. Liaise with internal and external NHS staff regarding case notes, data collection (i.e. discharge summaries), archival tumour block requests (under supervision for retrospective block requests only), mortality data, and other general trial activities, which may be confidential and sensitive in nature.
7. Booking seminar rooms for team, trial related and other miscellaneous meetings, producing minutes in a timely manner if required.
8. Assist with trial document archiving by following the Trust's archiving guidelines under supervision.
9. Ensure that office supplies are adequate and assist with the ordering process.

1. Be pro-active in providing feedback on working practices within the clinical research teams.
2. The post holder is expected to use initiative and be able to work independently but referring to the Senior Clinical Trials Coordinators/ Clinical Research Nurse Team Leaders as necessary.
3. The post holder is guided by relevant Trust and division SOPs. Patient recruitment managerial staff members are available as point of reference for any queries.

1. Participate in Trust and division-wide education programmes and study days as appropriate.

1. Long periods of time spent using keyboard to input information and use of VDU for electronic communication.
2. Prolonged concentration is regularly required (e.g. when checking through trial documentation and entering data into spreadsheets).
3. Occasional exposure to distressed circumstances as trial patients are commonly suffering from terminal illnesses.
4. Undertake general clerical/ housekeeping tasks as delegated by the clinical research teams to contribute to the smooth running of the patient recruitment teams.

Person Specification

Qualifications

Essential

1. Good level of education to GCSE.

Desirable

1. Evidence of further development.
2. ECDL qualification or equivalent.

Experience

Essential

1. Previous administrative/ clerical experience.

Desirable

1. Previous administrative/ clerical experience of working within clinical research.
2. Experience of working within a health care system.

Skills

Essential

1. Good organisational skills.
2. Good interpersonal skills.
3. Good oral and written communication skills.
4. Proficiency in typing and using spreadsheets.
5. Accuracy and attention to detail.

Desirable

1. Proficiency in the use of the Microsoft Office suite.

Knowledge

Essential

1. Familiarity with computerised systems.

Desirable

1. Knowledge of patient information systems.
2. Basic understanding of clinical research.

Other

Essential

1. Tactful and diplomatic.
2. Flexible.
3. Conscientious and hardworking.
4. Ability and willingness to learn.

Desirable

1. Ability to support team in working to unexpected deadlines.

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.

Employer details

Employer name

The Christie NHS FT

Address

Phase 1 - Q01312
Manchester
M20 4BX

Employer's website