Job Overview
Hours: 15 Hours with a view to increase
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.
Responsibilities
- 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.
- Work alongside the Project Manager to work from EDC guidelines to ensure proformas are reflective of the data collection needed.
- 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.
- Write policies and procedures relating to data where needed.
- 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.
- Support a culture of innovation, research and development, promoting evidence-based practice.
- Promote sharing of best research practice.
Experience
- 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 (desirable)
- Experience of problem solving & the ability to work autonomously.
- Experience in using various EDC platforms.
- Experience in using IT programmes.
- Experience of working to tight deadlines and managing a range of priorities.
- Experience in Systmone (desirable)
- Experience in reviewing paperwork relating to research to extract information required for specific purpose (desirable)
- Knowledge of research governance and regulations (ICH GCP & EU directives)
- 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. (desirable)
- Knowledge of clinical trials protocols & their application in practice. (desirable)
- Knowledge of clinical governance. (desirable)
Pay: £14.89 per hour
Benefits:
- Company pension
- Cycle to work scheme
- Free parking
- On-site parking
- Sick pay
Work Location: In person
