Clinical Trials Coordinator

Job description

Job responsibilities

DUTIES AND RESPONSIBILITIES

The specific responsibilities will depend on the requirements of each team, but may include:

• Act as a point of contact for the R&D core team, study sponsors, clinical research organisations and specific research teams, communicating directly with them regarding data queries, monitoring visits and other enquiries relevant to trial set up and general trial conduct.
• Set up and initiation of allocated trials within an assigned team, under the guidance of the Senior Clinical Trials Coordinators.
• Track all payments throughout each clinical trial including completion of activity logs and requesting invoices to be raised.
• Maintain investigator site files and essential documentation in accordance with ICH-GCP and Trust SOPs to ensure they are kept inspection ready at all times..
• Process trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines.
• Provide administrative support to the Clinical Research Nurses and Principal Investigators for safety reporting in accordance with protocol requirements.
• Complete team reporting mechanisms (i.e. recruitment activity logs, patient visit logs, costing spreadsheets, case report form trackers and electronic proformas).
• Produce trial workbooks for review by the lead Clinical Research Nurse and Principal Investigator for assigned studies.
• Ensure collection of clinical case notes for all patients, so that these are available as needed, for monitoring and audit purposes.
• Complete case report forms as per sponsor requirements, and liaise with clinical trial monitors to ensure the data sent is valid and their requirements are met at site monitoring visits.
• Liaise with internal and external NHS staff regarding case notes, data collection, archival tumour blocks, mortality data, and other general trial activities, which may be confidential and sensitive in nature.
• Ensure that scans are reproduced in a timely manner for the purposes of the clinical trial and that they are dispatched according to study protocol.
• Arrange the shipment of tumour samples for central laboratory analysis according to protocol requirements.
• Arrange team and trial related meetings as required, producing minutes in a timely manner.
• Ensure that data is available and up to date for any meetings related to a clinical trial.
• Attend project related meetings, investigator meetings (abroad or teleconferences, as necessary) to convey the relevant information to the study team.
• Assist with preparation for audit and inspections within assigned teams.
• Assist with trial document archiving by following the Trusts archiving guidelines.
• Ensure that office/ trial related supplies are adequate and assist with the ordering process.
• Undertake general administrative tasks as delegated by managerial representatives from the R&D division to contribute to the smooth running of the patient recruitment teams.

WORKING PRACTICE

• Work closely with the R&D management team to ensure adherence to new SOPs and working procedures rolled out divisionally.
• Be pro-active in providing feedback on working practices within the research team and suggest new ways of working.
• The post holder is expected to use initiative and be able to work independently without close supervision. They are also expected to plan and organise their own time and workload activity with prioritisation, referring to the Senior Clinical Trials Coordinators as necessary.
• The post holder is guided by relevant protocols and SOPs, and expected to exercise judgement outside these areas. However, the R&D managerial team members are available as point of reference for any queries and will meet regularly with staff.

PERSONAL AND PEOPLE DEVELOPMENT

• Maintain professional development whilst evaluating own specialist knowledge with assistance from the assigned line manager, to satisfy the NHS Knowledge and Skills Framework.
• Participate in Trust-wide education programmes and study days, regional and national meetings and research seminars as appropriate.
• Assist with induction training, support and mentoring for new post holders under the direction of the R&D management team

PHYSICAL, MENTAL AND EMOTIONAL EFFORT

• Long periods of time spent using keyboard to input information and use of VDU for electronic communication.
• 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

Person Specification

Qualifications

Essential

• Diploma or administration experience.
• Relevant research experience

Desirable

• Degree in a science or health related discipline.
• Relevant training courses in clinical research.

Experience

Essential

• oExperience in clinical trial administration including data management.

Desirable

• oExperience of working within a health care system

Skills

Essential

• oGood organisational skills.
• oGood interpersonal skills
• oGood oral and written communication skills.
• oIT literate
• oAttention to detail.

Desirable

• Good understanding and demonstrated use of the full Microsoft Office suite.
• oUnderstanding of case report forms

Knowledge

Essential

• Knowledge of the clinical trials process.
• Familiar with GCP guidelines/EU directives

Desirable

• Understanding of medical terminology and cancer.
• Knowledge of clinical Governance.
• Knowledge of patient information systems.

Other

Essential

• Ability to work to tight and/or unexpected deadlines.
• Tactful and diplomatic.
• Flexible
• Conscientious and hardworking
• Ability to work unsupervised or as part of a team

Desirable

• Ability to troubleshoot effectively

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

Wilmslow Road

Manchester

M20 4BX

Employer's website

https://www.christie.nhs.uk/ (Opens in a new tab)