Job Profile (To be attached to the relevant Grade Profile document)

Core job information

Job Title Study Coordinator / Monitor

Dept./School/Inst. William Harvey Research Institute

Section/Centre/Unit

Experimental Medicine & Rheumatology

Career Family Professional Grade 4

Working hours per week

35 hours 1.0 FTE Appointment period

24 months

Reports to (job title) EMR Clinical Trials Centre Manager

Current location Charterhouse Square

Job purpose (Why does the job exist? What is it there to achieve or deliver?)

The purpose of this job is to support a portfolio of clinical trials of investigational medicinal products (CTIMPs) and non-CTIMPs being conducted within the Centre for Experimental Medicine & Rheumatology (EMR) at QMUL & Barts Inflammatory Centre, Mile End Hospital, Barts Health Trust, in two areas:

1) Trial Monitor: to monitor clinical trials of investigational medicinal products (CTIMPs) and non-CTIMPs to overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s). The post-holder will be responsible to accurately document monitoring findings in a monitoring report and work effectively with participating trial sites to follow-up on actions to resolution. Additionally the post-holder will be required to summarise findings effectively to the EMR Trial Managers, EMR Clinical Trials Centre Manager, Chief Investigator and Sponsor.

2) Study Coordinator: to oversee all study coordination activities relating to the set-up of hosted studies at the Barts Inflammatory Centre, Mile End Hospital, Barts Health Trust and where applicable, at participating sites of QMUL sponsored multi-site trials, The post-holder will oversee on-going management of the study in terms of data and specimens collection and communications to ethics committees and/or regulatory bodies as applicable.

In both areas, the post-holder will ensure compliance with ICH-GCP (Good Clinical Practice) and current relevant regulatory legislation Medicines for Human Use (Clinical Trials) Regulations 2004, Data Protection Act 1998, the Human Tissue Act 2004, and sponsor requirements.

Knowledge, Skills & Experience (work experience, qualifications, specialist training, key skills, disposition)

Requirements Essential/Qualifications Undergraduate degree in healthcare, biological science or related

field and/or nursing qualificationEssential

Experience Involvement in health related researchExperience of clinical trials and research approvals processExperience in Rheumatology trialsExperience of working with staff from a range of different professional backgrounds and varying levels of seniorityExperience of on-site trial monitoring, writing up detailed, concise reports for monitoring and/or audit visits for research projectsExperience of clinical trial/health research quality assuranceExperience of data management/data-cleaning processes of clinical trialsExperience in set-up of new clinical trials, preparing risk assessments, monitoring plans

EssentialEssentialDesirableEssential

EssentialEssentialEssentialDesirable

Knowledge, skills & abilities

In-depth understanding of clinical research, clinical governance issues and principles of GCP Monitoring and audit procedures of clinical trialsStructure of health research funding bodies Regulatory framework for data protection including data protection actAble to communicate effectively with a wide range of internal and external staffAbility to identify priorities, initiate action and work independently, take forward multiple tasksComputer literacy, including word processing, spreadsheets, databases and literature searchesExcellent presentational skills

Essential

EssentialDesirableEssentialEssentialEssential

EssentialDesirable

Attitude & disposition Excellent communication, negotiation, presentation and interpersonal skillsHave high standards of accuracy and attention to detailWillingness to learn new skills and work in a changing environmentEnthusiasm for extending own learning and learning of others

EssentialEssentialEssentialEssential

Other circumstances Willingness to work flexiblyWillingness to travel between different trial sites and institutions

EssentialEssential

Main Duties and Responsibilities of the RoleMonitoring/AuditsIn conjunction with the EMR Clinical Trials Centre Manager, the post-holder will also be required to undertake audit and monitoring of participating sites of external partipicating trial sites of EMR clinical trials. Responsibilities will include:

In conjunction with the EMR Clinical Trials Centre Manager, carrying out audit and monitoring of all CTIMPs and non-CTIMPs supported by the Centre for EMR. This will include:

Ensuring that the trial is conducted and documented properly. Acting as the main line of communication between the Head of Centre, EMR Clinical Trials Centre

Manager and EMR Trial Managers and the investigator. Maintain a database of audit and monitoring findings based upon monitoring outcomes. Maintaining absolute confidentiality of all information relating to the sponsor, staff, studies, and study

participants. Verifying that the investigator has adequate qualifications, resources and facilities to conduct the study

safely Ensuring that all findings are reported to Head of Centre, EMR Clinical Trials Centre Manager and EMR Trial Managers for appropriate action.

Ensuring that JRMO Research Governance and GCP managers are provided with all final versions of monitoring and audit reports

General duties Maintaining absolute confidentiality of all information relating to the sponsor, staff, studies, and study

participants. To assist the EMR Clinical Trials staff to carry out risk assessment for all new studies adopted by the

EMR Clinical Trials Centre to determine level of monitoring and audit required in the form of a Monitoring Plan

To have an in depth knowledge of current regulations governing the conduct of clinical trials. To assist with the preparation for inspections /audits by regulatory authorities such as MHRA and HTA in

conjunction with the JRO To ensure they are fully aware of and comply with the College/Trust policies and procedures in relation

to inter alia, confidentiality, health and safety at work, COSHH regulations, infection control, safe handling of drugs and all local safety rules regarding fire, chemical, radioisotope and gene manipulation hazards as applicable.

Study Coordination The Study Coordinator will assist with the coordination of studies within the Centre for Experimental

Medicine & Rheumatology (EMR) at QMUL & Barts Inflammatory Centre, Mile End Hospital, Barts Health Trust portfolio of studies. Responsibilities will include:-

Ensuring that EMR studies are conducted and documented properly requiring thorough knowledge of all

study protocols First point of contact for day to day queries raised by participating study centres Lead on all data management activities, working with database programmer on database development,

CRF design, data management plan and data cleaning procedures Sample tracking and management Ethics and Regulatory approval applications as well as subsequent amendment submissions. Submissions to the Coordinated System for NHS permission (CSP). Site initiation / close down visits. Co-ordinating site payment where applicable. Writing Standard Operating Procedures, Guidelines and Work Instructions. Trial websites

Other The post holder must at all times carry out their responsibilities with due regard to the College’s Equal

Opportunities and Health and Safety policies. These duties will be subject to review in line with the changing requirements of the Centre, Institute,

School or College and with the development needs of the post holder as identified through regular review/appraisal processes.

The 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 the level of responsibility entailed. Such variations are a common occurrence and cannot of themselves justify a reconsideration of the grading of the post.

Working Environment (knowledge of special working practices, breadth of management skill required, customer impact, responsibility, efficiency)

To maintain high level of in depth knowledge of regulations governing clinical trialsTo ensure trials supported by the unit are of high quality and comply with regulatory and sponsor requirements by carrying out regular monitoring To identify need for new standard operating procedures (SOPs) relating to research governance and quality assurance systems within the Unit and alert EMR Clinical Trials staff as necessaryAssist the EMR Clinical Trials Centre Manager in the ongoing development of the EMR Clinical Trial Centre’s quality management systemThe post sits within the Centre for Experimental Medicine & Rheumatology (EMR), which is part of the School’s William Harvey Research Institute. The post-holder may work with staff at the Bart’s Clinical Trials Unit (Wolfson Institute) in the running of EMR clinical trial activities.The post-holder will also work closely with the clinical research staff at the Rheumatology Department (Mile End Hospital) to optimally deliver EMR clinical trial activitiesThe post would require regular travel within the UK and Europe to monitor trial sites

Freedom to Act & Decision Making (depth of control, supervision received, use of judgement & initiative, analytical ability)

1. Expected to manage personal workload and be able to prioritise specific tasks2. Expected to use own judgement to identify particular research governance issues in research projects as

they arise3. Expected to draft clear, concise, detailed monitoring reports based on own findings and conclusions

Communication & Networking (liaison with others, type and level of communications)

1. Day to day liaison with Head of Centre, EMR Clinical Trials Centre Manager, EMR Trial Managers , Chief investigator/Principal Investigators, study staff and the Joint Research Office:

- Communicating deviations from the protocol, SOPs, GCP, and the applicable regulatory requirements to the investigator and EMR Clinical Trials Centre Manager, and taking appropriate action designed to prevent recurrence of the detected deviations.

- Communicating potential serious breaches of GCP and the trial protocol to the EMR Clinical Trial Managers, EMR Clinical Trials Centre Manager and sponsor. Ensuring that any reported breaches have been reported within the time-lines specified in the regulations

- Ensuring that the investigators notify the sponsor of early termination and end of trial within the

time-lines specified by the regulations

2. Frequent liaison with site study staff for sites external to BLT/QMUL for EMR Clinical Trials Centre supported studies

3. Frequent liaison with laboratory, pharmacy and other facilities staff involved in support of EMR Clinical Trials Centre studies

Finance/Resource Management (budgeting, forecasting)

No budgetary management

People Management (supervisory responsibility, human relations skills)

No formal line management but the post-holder will be expected to mentor and supervise more junior members of the team, for example, Clinical Trials Associates (CTAs).

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 responsibility entailed. Such variations are a common occurrence and cannot of themselves justify a reconsideration of the grading of the post.

Organisation Chart William Harvey Research Institute

Deputy DirectorsAdrian Clark & Mauro Perretti

Institute DirectorMark Caulfield

Bone & Joint Research

Unit

ChernajovskjyMageedNissim

Kabouridis

Biochemical Pharmacology

FlowerPerretti

GouldingD’Aquisto

Translational Medicine and Therapeutics

ThiemermannSuzukiWarnerCorderYaqoob

Hinds/ PearseChan

Experimental Medicine &

Rheumatology

PitsalisDell’Accio

Warden’s TeamSchool Exec

Endocrinology

ClarkKorbonitsChappleBurrin

GrossmanChew

JenkinsSavege/Storr

ClinicalPharmacology

CaulfieldJohnstonAluhwaliaMunroe

YeLeung

Langford

Cardiovascular Medicine Endocrine ResearchInflammation Science

BLT Rheumatology BLT Cardiac/ Renal & Intensive Care

BLT Cardiology, Gen Med, East London PCTs, Anaesthesia

Clinical Endocrinology & Gen Med

Institute ManagerDenise Elliott

Microcirculation Research

Nourshargh

MicrovascularResearch

Nourshargh