Job summary
An exciting opportunity has become available to join The Adam Practice Research Team working within the Dorset Primary Care Clinical Research Group (DPCCRG). The group is formed alongside The Adam Practice & 5 other surgeries within our patch. The aim of the DPCCRG is to offer research to a wider population meaning that more patients can be involved in research for better health outcomes.
This is an exciting role for an experienced Data Manager to join the team. You will be an integral part of the team & must be able to use your knowledge & skills to help produce a high standard.
Main duties of the job
Working closely with the Clinical Trials Manager & the Lead Research Nurse as a
point of contact for commercial and Non-Commercial sponsors. Additionally,
working with other members of The Adam Practice Research team (DPCCRG) to ensure
smooth running of research studies within the practice.
Develop effective working relationships with the
site Principal Investigators, Sponsor team and other study staff to ensure
appropriate support is in place to enter accurate & concise data into the
Electronic Capture Data (EDC) system.
Assist
nurses & sponsors with data entry queries & resolutions.
Work with the Clinical
Trials Manager to conduct protocol-based searches on SystmOne using protocols
provided by the sponsor to identify possible study participants.
Assist
the research team in general admin duties such as making participant folders,
emailing participants, sending post to participants, completing EDGE data &
answering queries, scanning documents, formulating spreadsheet for research
use, archiving study documents.
Explain
and promote assigned studies (including newsletter production, website updates)
to ensure wide participation and good accrual of patients.
Promote
a culture of good customer service.
Ensure clear and effective communication is
maintained with the sponsor and The Adam Practice Research Team.
Have excellent attention to detail &
organisation skills.
Contribute to regular team briefings and
meetings.
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.
Job description
Job responsibilities
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.
Job description
Job responsibilities
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.
Person Specification
Other requirements specific to role
Essential
- Ability to undergo personal development and learn new skills.
- Attention to detail.
- Clear verbal communication.
- Able to work under own initiative and independently outside of the department without direct supervision.
-
- Ability to prioritise tasks and manage time effectively, coping with deadlines.
- Able to proactively work with colleagues in other work areas to achieve outcomes.
- Able to delegate effectively, understanding the strengths and weaknesses of team members to build effective teamwork.
Personal Attributes
Essential
- Professional attitude to work, diplomatic and calm under pressure.
- Compassionate and sensitive to the needs of patients, carers and colleagues.
- Good interpersonal, communication, organisation and time management skills.
- Proactive approach and able to adjust to pressures of the job.
- Ability to demonstrate integrity.
- Team player.
- Patient, dependable and motivating.
- Flexible, reliable and uses initiative.
- Be able to take directions.
Technical Skills Competencies
Essential
- IT literate.
- Knowledge of Microsoft applications for managing information including word & excel.
- High standards of literacy, numeracy and attention to detail.
Desirable
- Project Management skills
- Basic understanding of working with a variety of web-based platforms (e.g. NIHR ODP, Edge, IRAS, Rave)
Experience
Essential
- Previous of working in Primary Care research.
- Experience of using SystmOne (electronic medical record system).
- Significant experience of working to tight deadlines and managing a range of priorities.
- Experience of working to tight deadlines and managing a range of priorities.
Desirable
- Knowledge and experience of clinical research methodology and statutory clinical trial regulations, GCP and research governance requirements.
- Experience in data management
- Experience of successful project management
Knowledge
Essential
- Understanding of medical terminology.
- Excellent written and oral communication skills.
Desirable
- 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.
Qualifications
Essential
- Educated to degree level OR equivalent experience in administration work.
- A willingness to undergo personal development and training and learn new skills.
Desirable
- Able to demonstrate equivalent level of knowledge, skills and understanding in clinical research.
- Current certificate of ICH GCP training.
Person Specification
Other requirements specific to role
Essential
- Ability to undergo personal development and learn new skills.
- Attention to detail.
- Clear verbal communication.
- Able to work under own initiative and independently outside of the department without direct supervision.
-
- Ability to prioritise tasks and manage time effectively, coping with deadlines.
- Able to proactively work with colleagues in other work areas to achieve outcomes.
- Able to delegate effectively, understanding the strengths and weaknesses of team members to build effective teamwork.
Personal Attributes
Essential
- Professional attitude to work, diplomatic and calm under pressure.
- Compassionate and sensitive to the needs of patients, carers and colleagues.
- Good interpersonal, communication, organisation and time management skills.
- Proactive approach and able to adjust to pressures of the job.
- Ability to demonstrate integrity.
- Team player.
- Patient, dependable and motivating.
- Flexible, reliable and uses initiative.
- Be able to take directions.
Technical Skills Competencies
Essential
- IT literate.
- Knowledge of Microsoft applications for managing information including word & excel.
- High standards of literacy, numeracy and attention to detail.
Desirable
- Project Management skills
- Basic understanding of working with a variety of web-based platforms (e.g. NIHR ODP, Edge, IRAS, Rave)
Experience
Essential
- Previous of working in Primary Care research.
- Experience of using SystmOne (electronic medical record system).
- Significant experience of working to tight deadlines and managing a range of priorities.
- Experience of working to tight deadlines and managing a range of priorities.
Desirable
- Knowledge and experience of clinical research methodology and statutory clinical trial regulations, GCP and research governance requirements.
- Experience in data management
- Experience of successful project management
Knowledge
Essential
- Understanding of medical terminology.
- Excellent written and oral communication skills.
Desirable
- 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.
Qualifications
Essential
- Educated to degree level OR equivalent experience in administration work.
- A willingness to undergo personal development and training and learn new skills.
Desirable
- Able to demonstrate equivalent level of knowledge, skills and understanding in clinical research.
- Current certificate of ICH GCP training.
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.
