Job Profile Job Description

Job Details Job Title: Clinical Research Associate (Maternity Leave Cover) School/Dept/Institute & Centre: Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry. Reports to: Lead CRA/Senior Clinical Trials Coordinator Grade: Professional 3 (£26,270 - £32,405) Full Time (35 hours per week) Appointment period: 12 months Current Location: Charterhouse Square

Job Context The Centre for Cancer Prevention is part of the Wolfson Institute of Preventive Medicine, which has a focus on academic discipline, research, the translation of research into public health strategies and their practical implementation – all dedicated to the reduction of disease and disability.

The Centre for Cancer Prevention is at the forefront of research internationally into the prevention and control of cancer. We have particularly active programmes in research studying breast, cervical, colorectal and prostate cancer prevention, cancer screening and statistical methods for clinical trials and epidemiology.

Our objectives are:  To facilitate development of new cancer screening and prevention approaches and to fully evaluate currently available methods  To apply new discoveries in basic cancer biology to cancer screening and prevention

The Barts CTU sits within the CCP and it has a number of branches, including the Cancer Prevention Trials Unit (CPTU), the Centre of Experimental Medicines (CECM), the Experimental Medicine & Rheumatology Clinical Trials Centre (EMR CTC) and the National Facial Oral and Oculoplastic Research Centre (NFORC). The unit is considering expanding in new disease areas and new collaborations are being considered e.g. with the Cardiovascular CTU at QMUL. The Barts CTU is a UKCRC registered trials unit.

Job Purpose

 To undertake data management and pharmacovigilance duties for a large, multi-centre, international IMP trial (CTIMP).  To act as a core point of contact for participating trial sites (global), assisting in all trials-related matters.

Main Duties & Responsibilities Data Management and Central Monitoring

 Work within the data management team and have responsibility for data-management of a sub-set of participating sites  Assist with data cleaning activities as necessary to ensure that data being received from trial sites are accurate and contain no inconsistencies. Assist in sending data queries to trial sites where necessary and processing responses to any queries sent  Carry out central review of trial data and following up on any actions until resolution  Identify and document protocol deviations  To review and manipulate large data sets in software and database applications  Provide feedback at team meetings on trial site data quality to inform risk-based monitoring strategies

1 Job Profile Job Description

Main Duties & Responsibilities

 Provide data summaries and feedback prior to site monitoring visits on data quality and returns  Liaise and collaborate with database programmer(s) where necessary  Contribute to design and testing of electronic case report forms (eCRFs)  Produce concise data summaries that can be used in reports

Pharmacovigilance activities  Receive, review, document and report Serious Adverse Events (SAEs) according to standard operating procedures and relevant legislation  Liaise with trial sites and applicable drug safety colleagues for pharmacovigilance queries  Maintenance of all applicable databases  Coordinate the distribution of 6-monthly SUSAR reports to participating trial sites

General duties  Ensure that all research is undertaken according to Good Clinical Practice (GCP), Barts CTU, College and Sponsor SOPs  Attend clinical trials training sessions and undertake continuous professional development addressing current issues in clinical research or as deemed required for the role  Assist the data management team and other members of the team with other activities and general administration tasks (including minute taking and TMF maintenance tasks)  Ensure patient confidentiality is maintained at all times and fulfils the requirements of the Data Protection Act  Play an active role within the team and work closely with the Project Manager, Senior Clinical trials Coordinator Data Management team, and other Barts CTU staff as applicable  Attend and contribute to regular trial team meetings

The above list of responsibilities is not exhaustive and the jobholder may be required to undertake other duties commensurate with the level of the role, as reasonably requested by their line manager.

This job description sets out the duties of the post at the time it was drawn up. Such duties may vary from time to time without changing the general character of the duties or level of the responsibility entailed. Such variations are a common occurrence and cannot in themselves justify a reconsideration of the grading of the post.

2 Job Profile Person Specification

This table lists the essential and desirable requirements needed in order to perform the job effectively. Candidates will be shortlisted based on the extent to which they meet these requirements.

Essential / How Requirements Desirable Assessed Qualifications Educated to A-Level (grades A-C) E A/I Undergraduate degree D A Current Good Clinical Practice Qualification D A Knowledge, Experience of working in a clinical research environment (higher E A/I/OM Skills and education, NHS, CRO or commercial). Experience Good understanding of GCP regulations E I/OM Skilled in use of Microsoft Excel for data entry/sorting/processing E A/I/OM Excellent communication skills and ability to communicate with a E A/I/OM wide range of people, including staff in study centres in Europe (verbal, written and presentations) Ability to work independently, without supervision on a day-to-day E A/I/OM basis, as well as part of a team Excellent attention to detail and analytical skills E A/I/OM Experience of working with medical terminology and E A/I/OM medical/technical writing skills Proven time management skills by working to tight deadline E A/I/OM Willing to travel between sites E A Experience of pharmacovigilance activities D A/I/OM Experience of data management and monitoring D A/I/OM

Experience of working with database software (e.g. Access, SQL, D A/I/OM Oracle) Experience of using electronic data capture forms (eCRFS) D A/I Past experience of clinical trials administration including trial master D A/I file maintenance

Essential/Desirable: E = Essential: Requirements without which the job could not be done. D = Desirable: Requirements that would enable the candidate to perform the job well.

How Assessed: A = Application I = Interview OM = Other Means (e.g. presentation, test, etc.)

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