Detailed Job Description and Main Responsibilities
DUTIES AND RESPONSIBILITIES
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.
WORKING PRACTICE
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.
PERSONAL AND PEOPLE DEVELOPMENT
1. Participate in Trust and division-wide education programmes and study days as appropriate.
PHYSICAL, MENTAL AND EMOTIONAL EFFORT
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 Criteria
1. Good level of education to GCSE.
Desirable Criteria
1. Evidence of further development.
2. ECDL qualification or equivalent.
Experience
Essential Criteria
1. Previous administrative/ clerical experience.
Desirable Criteria
1. Previous administrative/ clerical experience of working within clinical research.
2. Experience of working within a health care system.
Skills
Essential Criteria
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 Criteria
1. Proficiency in the use of the Microsoft Office suite.
Knowledge
Essential Criteria
1. Familiarity with computerised systems.
Desirable Criteria
1. Knowledge of patient information systems.
2. Basic understanding of clinical research.
Other
Essential Criteria
1. Tactful and diplomatic.
2. Flexible.
3. Conscientious and hardworking.
4. Ability and willingness to learn.
Desirable Criteria
1. Ability to support team in working to unexpected deadlines.
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