NIHR Dorset PC CRDC Data MangerNHS

Job summary

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 Data Manager to be part of a new network of Commercial Research Delivery Centre (CRDC) in Primary Care (PC) to deliver clinical trials across Dorset within the NIHR CRDC Dorset (PC). Our NIHR CRDC Dorset (PC) is a solid collaboration consisting of 5 practices who have committed to work collaboratively & have done for the past 2 years delivering commercial clinical trials to participants across the patch. The vision of the NIHR CRDC Dorset (PC) is to enable practices across Dorset, who so wish to be research active, achieve this through the ongoing support of the CRDC Dorset (PC). The Adam Practice hosts the CRDC Dorset (PC) and will support R&D function including study set up & delivery. All the practices in the CRDC Dorset (PC) are partners and work as spokes delivering clinical trials for patient benefit.

Main duties of the job

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

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

Co-ordinate data collection: ensure timely submission of accrual data; review data for completeness and accuracy where appropriate, liaising closely with the study management team.

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

Co-ordinate the design, printing and distribution of trial documentation, and ensure all paperwork is of the appropriate standard.

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

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

Support the coordination and preparation of documentation required for regulatory monitoring and auditing.

Maintain awareness of regulatory requirements, i.e. NHS Research Ethics Committee, UK Policy Framework for Health and Social Care Research (2017), ICH-GCP, GDPR, and advise others accordingly.

Job description

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

Support feasibility and risk assessment of assigned studies along with the Clinical Trials Manager whilst maintaining comprehensive knowledge of resources available to assist researchers in the development and delivery of high-quality clinical research.

Ensure a consistent approach to local study documentation taking account of regulations and 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.

Build and maintain a productive working relationship with colleagues across the organisations involved in study delivery and clinical networks

Communicate with participating sites across the network to ensure current knowledge on study recruitment and performance evaluation against targets.

Support research study management and high-quality study delivery.

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 ofOutstanding 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.