MRC UNIT THE GAMBIA

JOB DESCRIPTION

1 Job title: CLINICAL TRIAL MONITOR

2 Introduction

The Medical Research Council Unit The Gambia (MRCG) has an international reputation for ground-breaking research into some of the leading causes of morbidity and mortality in the tropics. Achievements include a large trial showing the efficacy of Haemophilus influenzae type B vaccine in The Gambia and the subsequent near elimination of the disease, pioneering work on the impact of insecticide treated bed nets as a preventive measure against malaria leading up to their worldwide use, and studies demonstrating the impact of conjugate pneumococcal vaccines on pneumonia and child mortality.

To reflect changes in national and global health priorities a new research portfolio has been organized under three themes at MRCG: Nutrition, Disease Control & Elimination and Vaccines & Immunity. Research in these themes seeks to target health needs of developing countries, to reinforce sub-regional and international collaborations and to address some of the major current priorities formulated in the WHO Sustainable Development Goals.

Clinical trials conducted within the themes are supported by The Unit’s Clinical Trials Support Office (CTSO). CTSO supports investigator teams to deliver clinical trials in line with ethical and regulatory requirements, and following the principles of internationally recognised quality standards. This involves training research teams and providing advice throughout all stages of early and late phase clinical trials.

CTSO is also responsible for overseeing compliance of clinical trials at the Unit to ensure they are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), the principles of ICH GCP, and applicable regulatory and ethical requirements.

In this context, the role of Clinical Trial Monitor is essential to facilitate and ensure delivery of research of the highest possible standards.

3 Grade: 4, 23 Points.

4 Purpose of Job

The post-holder will work in a team of Clinical Trial Monitors to ensure clinical trials at MRCG are conducted in line with applicable requirements. This involves regular reporting on oversight and support activities to the Clinical Trials Department Coordinator and Research Governance Manager. The post-holder will support investigators and their teams to develop trial-specific procedures and provide input and advice on best practice at all stages of the trial. The post-holder promotes quality and compliance by engaging with research teams in a positive manner through trainings, workshops and ad hoc meetings. The role is an essential link between activities in the field/trial site and the sponsor’s office. Where MRCG acts as clinical trial sponsor, the Clinical Trial Monitor supports delivering appropriate sponsor oversight. Where MRCG is not the sponsor the clinical trial monitor supports the investigator in meeting local regulatory and MRCG requirements.

5 Key Responsibilities:

5.1 Clinical trial monitoring Support development of risk-based monitoring plan. Conduct site initiation visits, interim visits and close-out visits.

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Provide on-site monitoring according to the clinical trial protocol, monitoring plan and MRCG procedures.

Review informed consent process and documentation at trial site. Review source data, SAE and all trial related documentation for accuracy, contemporaneity and

completeness. Positively and effectively communicate and discuss monitoring findings with investigator teams. Facilitate the development and implementation of corrective action plans. Prepare accurate and timely monitoring reports and follow-up letters. Follow-up issues and corrective actions consistently, effectively and timely. Proactively engage research teams to pre-emptively identify and address areas of concern. Deliver a range of remote monitoring activities, including review of trial data. Critically review monitoring reports for trials monitored by external parties. Check trial facilities are adequate, including storage areas (drugs, records), labs, spaces for

treatment and informed consent and other areas. Confirm investigational products are handled, stored and used in line with the protocol and Unit

SOPs. Ensure samples and records are stored appropriately with adequate environment controls.

5.2 Clinical trial support Act as focal point for communication with the trial team for MRCG sponsored trials and contact

site staff regularly. Register clinical trials on public databases and update entries, as required. Record SAE reports and notify regulatory authority and sponsor and ensure events are followed-

up appropriately by the investigator. Review Data Safety Monitoring Board (DSMB) and Trial Steering Committee (TSC) charters for

MRCG-sponsored trials, as applicable. Advise trial teams on latest changes in regulatory environment and international guidelines. Oversee that MRC-sponsored studies are well managed and delivered to expected timelines. Maintain appropriate sponsor records for MRCG-sponsored trials. Ensure trials are conducted in line with the principles of ICH GCP and GCLP, regulatory

requirements and ethical guidelines. Prepare regular trial updates to oversee recruitment rate and compliance. Liaise with national regulatory authority. Support development of Study-Specific Procedures (SSP). Oversee training of investigator teams on the protocol SOP and SSP. Oversee training of investigator teams in consenting procedures. Training of all Unit staff on principles of ICH GCP and ethical requirements. Pro-actively guide and support investigator in completing pre-trial activities required for sponsor

study-start approval. Support development and review of trial-specific risk assessments.

5.3 Other Support review of Unit SOPs. Facilitate regular Clinical Trials Group meetings. Maintain CTSO databases, trackers and resources. Report on CTSO activities on SharePoint and to the Communications department as required. Support CTSO department administration. Drive and advocate good research practice in The Unit.

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The post will require frequent travel, including overnight stays.

Job descriptions cannot be exhaustive and the post-holder may be required to undertake other duties in line with the overall remit and level of the post.

The job-holder is expected to observe MRC’s and MRCG’s policies, SOPs and code of conduct.

6. Relationships:

(i) The post-holder is a full-time member of the MRC staff.

(ii) The post-holder will report to Mrs Vivat Thomas-Njie.

(iii) The Head of Research Governance is Dr Jonas Lexow.

(iv) The Director of Operations is Mr Joan Vives Tomas.

(v) The Unit Director is Prof. Umberto D’Alessandro.

7. Length of appointment:

The appointment is up to 31st March 2021 and is subject to a probationary period of

8. Appraisals:

Appraisals are held at least annually.

9. Any other duties:

Perform any other duties consistent with the remit of the post.

Signed Post-holder:

Date:

Signed Line Manager:

Date:

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PERSON SPECIFICATION

Clinical Trial Monitor

Qualifications: Essential

BSc Nursing, Biomedical Sciences or other relevant area or equivalent experience; or Research Nurse with at least 5 years work experience

Desirable

MSc or other postgraduate training in clinical trials

Knowledge and Experience:Essential

Minimum of 3 years experience working in a clinical research

Previous clinical trial monitoring experience

Excellent knowledge of ICH GCP and relevant ethical standards and regulations

Excellent command of written and spoken English

Desirable

Experience with electronic case report forms

Good understanding of Gambian clinical trials regulation

Skills and Abilities:

Essential Self-motivated, ability to work unsupervised

Excellent verbal and written communication skills with people at all levels Proven organisational and administrative skills Ability to work well in a team

Accuracy and attention to detail

Good working knowledge of Microsoft Office applications Word, Excel and PowerPoint

Desirable

Knowledge of database applications

Other Requirements:

Essential Willingness to travel internationally, including overnight stays Willingness to work flexibly, as required

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