Job Description

• Assist in the filing of clinical trial documentation in investigator site files in accordance with ICH-GCP and Trust SOPs.
• Assist in completing team reports (i.e. recruitment activity logs, patient visit logs, case report form trackers and electronic proformas).
• Ensure collection, tracking and general organization of clinical case notes for all patients, so that these are available as needed for monitoring and audit purposes.
• General assistance with preparation for monitoring visits and follow up actions under supervision.
• Photocopying and internal delivery/ transfer of clinical trial/ miscellaneous documentation (i.e. case report forms, contracts, trial set-up documentation, copies of scans). 
• Liaise with internal and external staff regarding case notes, data collection (i.e. discharge summaries), archival tumor block requests (under supervision for retrospective block requests only), mortality data, and other general trial activities, which may be confidential and sensitive in nature.
• Booking seminar rooms for team, trial related and other miscellaneous meetings, producing minutes in a timely manner if required.
• Assist with trial document archiving by following the Trust’s archiving guidelines under supervision.
• Ensure that office supplies are adequate, and assist with the ordering process.
• Undertake general clerical/ housekeeping tasks as delegated by the clinical research teams to contribute to the smooth running of the patient recruitment teams.
• Be pro-active in providing feedback on working practices within the clinical research teams.
• 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.
• 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.
• Prolonged concentration is regularly required (e.g. when checking through trial documentation and entering data into spreadsheets).
• Occasional exposure to distressed circumstances as trial patients are commonly suffering from terminal illnesses.

Required Knowledge, Skills, and Abilities