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 core Research and Development 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 and ensure version control is maintained.

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.

Cross check, confirm data and complete query resolution with sponsors and third parties in a timely manner.

Completion of clinical trial specific databases with data from various sources such as questionnaires, hospital records and other electronic and paper sources.

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.

Arrange shipping and delivery of relevant trial data and documents including import/export of tumour blocks, ECGs and copy scans.

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.

If required 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 Research Division to contribute to the smooth running of the patient recruitment Teams.

Demonstrates the agreed set of values and accountable for own attitude and behaviour.

Person Specification

Qualifications

Essential

• Diploma or administration experience.

Desirable

• Degree in a science or health related discipline.
• Relevant training courses in clinical research.
• Qualification in computing or information technology /Relevant IT experience

Experience

Essential

• Experience in administration including data management.

Desirable

• Experience of working within a clinical trials environment.
• Relevant experience within a Good Clinical Practice and research environment.

Skills

Essential

• Good written communication skills.
• Good understanding and demonstrated use of Microsoft Word and Excel.
• Accuracy and attention to detail
• Good organisational skills.
• Good interpersonal skills.
• Good oral communication skills

Desirable

• Good understanding and demonstrated use of the full Microsoft Office suite.

Knowledge

Essential

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

Desirable

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

Values

Essential

• Ability to demonstrate the organisational values and behaviours

Other

Essential

• Ability to work to tight and/or unexpected deadlines.
• Flexible with ability to adapt to service requirements.
• Hardworking; ability to manage a busy workload.
• Ability to work unsupervised or as part of a team.
• Tactful and diplomatic.

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

Clinical Trials Department - Q02054

Manchester

M20 4BX

Employer's website

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