Clinical Data Manager

Job description

Job responsibilities

CLINICAL SKILLS- desirable but not essential

• To be able to venesect patients if required in the clinical setting.

• To carry out ECG's under Registered Nurse/ Practitioner supervision when trained and assessed as competent to do so

• Undertake, record and escalate all clinical observations.

• Co-ordinate the processing and shipping of all trial biological samples.

• To coordinate and manage the logistics of a busy clinic

• Screening of clinic lists for eligible patients- running searches through practice system where available.

RESEARCH DATA ENTRY and ADMINISTRATION

• Competent in the use of IT, including excel and web-based databases.

• Responsible for the collection, co-ordination and computerisation of data generated from the clinical trials. (data collection, data entry and safe data storage).

• To take responsibility for liaising with Clinical Trials Units regarding data queries and for checking and resolving data queries

• To assist with the recording and reporting where appropriate of adverse events that occur whilst the patient is in the clinical trial to the relevant personnel and act as required.

• Assist the clinical research team in the day to day management of data for a portfolio of studies.

• Retrospective collection of patient data from medical notes and completion of case record forms (CRFs).

• To access up to date information on patients and their treatments e.g. accessing radiology and pathology systems

• Assist with ensuring study supplies are sustained as per laboratory manual by highlighting stock requirements and ordering with suppliers.

• Update internal systems to record study information and enrolled patients’ details.

• Assist the administrative team with regular site file maintenance to ensure study essential documents are version controlled and are maintained according to regulatory requirements.

OTHER RESPONSIBILITIES:

• Taking phone calls.

• Email and fax correspondence.

• Participate in Good Clinical Practice (GCP) training and ensures compliance.

• Support the implementation of new quality systems and processes across the department.

• Contribute to service development by actively participating in team meetings.

• Recognise the importance of key performance indicators and support the clinical research team to achieve them.

• Recognise the importance of and adhere to Standard Operational Procedures and policies without supervision.

• Prioritise a busy workload and manage multiple tasks when frequently interrupted.

• Provide cover during periods of absence for trial administrators.

• Undertake all mandatory training, take part in regular performance appraisal/development review

• Recognise the importance of and contribute to maintaining the health, safety and security of the clinical research team.

Person Specification

Experience

Essential

• Experience of working within a Healthcare setting

Desirable

• Experience in clinical trial/research data management
• Experience of working within a Clinical Trial setting

Knowledge and Skills

Essential

• Excellent communication and interpersonal skills Both written and verbal
• Evidence of accuracy to detail in data collection
• Car driver requirement to travel across sites possibly at short notice.
• Knowledge of medical terminology.
• Knowledge of trust policy regarding Data Protection - Caldicott Guidelines, Data Protection Act
• Good time management and a flexible willing attitude to work
• Ability to interact with staff at all levels, adapting approach and style as appropriate
• Ability to manage long periods of concentration and pressured work

Qualifications

Essential

• Demonstratable high level Numeracy & Literacy Skills
• Advanced computer literacy with Microsoft Office software (including word, excel, access and power point

Desirable

• Attended ICH GCP Training
• Appropriate healthcare qualification NVQ/Diploma

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

Praze Surgery

Address

School Road

Praze-an-Beeble

Camborne

Cornwall

TR14 0LB

Employer's website

https://www.prazesurgery.co.uk/ (Opens in a new tab)