NIHR Dorset PC CRDC Data Manger

This post is not open to oversee candidates due to salary requirements.

20 Hours per week to be decided with a view to increase over time.

This is an exciting role for a DataManager to be part of a new network of Commercial Research Delivery Centre(CRDC) in Primary Care (PC) to deliver clinical trials across Dorset within theNIHR CRDC Dorset (PC). Our NIHR CRDC Dorset (PC) is a solid collaborationconsisting of 5 practices who have committed to work collaboratively & havedone for the past 2 years delivering commercial clinical trials to participantsacross the patch. The vision of the NIHR CRDC Dorset (PC) is to enablepractices across Dorset, who so wish to be research active, achieve thisthrough the ongoing support of the CRDC Dorset (PC). The Adam Practice hoststhe CRDC Dorset (PC) and will support R&D function including study set up& delivery. All the practices in theCRDC Dorset (PC) are partners and work as spokes delivering clinical trials forpatient benefit.

Main duties of the job

Develop effective working relationships with thesite Principal Investigators, Sponsor team and other study staff to ensure appropriate support is in place to conduct research safely, efficiently andeffectively.

Ensurea consistent approach to local study documentation taking account of regulations and external requirements e.g. Trial Master Files.

Co-ordinate datacollection: ensure timely submission of accrual data; review data forcompleteness and accuracy where appropriate, liaising closely with the studymanagement team.

Monitortrial progress to ensure compliance with and adherence to the project plan andto identify, evaluate and help rectify problems alongside the Project Manager.

Co-ordinate thedesign, printing and distribution of trial documentation, and ensure allpaperwork is of the appropriate standard.

Providea high standard of data entry within databases and study management systems,this includes working within a variety of web-based platforms.

Createand maintain the study Investigator Site files and oversight of site files,ensuring these are kept tidy and current by appropriate filing ofdocumentation.

Support the coordination and preparation of documentation required forregulatory monitoring and auditing.

Maintainawareness of regulatory requirements, i.e. NHS Research Ethics Committee, UKPolicy Framework for Health and Social Care Research (2017), ICH-GCP, GDPR, andadvise others accordingly.

About us

The Adam Practice is a partnership located across 5 surgeries in Poole, Dorset. This is an exciting opportunity to join our growing primary care team in a forward- thinking, innovative, general practice, which has a current CQC rating of Outstanding in Care.

Here are some of our many benefits we offer;

Access to NHS Pension Scheme and NHS discounts, 5 weeks annual leave (inclusive of bank/public holidays that fall in the holiday year). Entitlement is pro-rata for part-time employees.

Auto enrolment in NHS Pension Scheme.

Cycle to work scheme.

Job responsibilities

Takeresponsibility for the necessary study applications as appropriate and assisting, advising participating investigators with local requirements.

Supportfeasibility and risk assessment of assigned studies along with the ClinicalTrials Manager whilst maintaining comprehensive knowledge of resources availableto assist researchers in the development and delivery of high-quality clinicalresearch.

Ensure aconsistent approach to local study documentation taking account of regulationsand external requirements e.g. Investigators Site Files (ISFs)

Promote and advise on the principles of Good Clinical Practice (GCP) and Good Research Practice within The Adam Practice Research team & DPCCRG.

Buildand maintain a productive working relationship with colleagues across theorganisations involved in study delivery and clinical networks

Communicatewith participating sites across the network to ensure current knowledge onstudy recruitment and performance evaluation against targets.

Support researchstudy management and high-quality study delivery.

Person Specification

Experience

• Experience of problem solving & the ability to work autonomously.
• Experience in using IT programmes.
• Experience of working to tight deadlines and managing a range of priorities.
• Experience in SystmOne
• Experience in reviewing paperwork relating to research to extract information required for a specific purpose.

Qualifications

• Educated to degree level in life sciences OR relevant experience
• ICH-GCP R3 training
• A willingness to undergo personal development and training and learn new skills
• Experience in research management

Qualities and Attributes

• Knowledge of research governance and regulations (ICH GCP & EU directives)
• Excellent communication & interpersonal skills.
• Ability to initiate, manage & sustain change.
• Ability to prioritise tasks and manage time effectively, coping with deadlines.
• Able to delegate effectively, understanding the strengths and weaknesses of team members to build effective teamwork.
• Good attendance at work.
• A flexible approach to work.
• Effective time management.
• Ability to work independently & as part of the team.
• Ability to organise, prioritise, co-ordinate own self & work
• Takes accountability for ones actions.Shares information & good practice appropriately.
• Treats others with courtesy & respect at all times.
• Working knowledge of the UK clinical trials regulations, Data Protection Act (1988), Mental Capacity Act, Human Tissue Act, ICH-GCP, Research Governance and ethical Frameworks.
• Knowledge of clinical trials protocols & their application in practice.
• Knowledge of clinical governance.

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.

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