KEY TASKS AND RESPONSIBILITIES
Part time role - 2 days per week.
Research
- Engagement:
- Identifying Studies: The research GP will work with the research team to help identify potential studies that align with the site's capabilities and patient population. This involves understanding the research landscape and staying updated with new opportunities.
- Building a Portfolio: The research GP will work with the research team to help develop and maintain a diverse portfolio of research projects, ensuring a balance between different types of studies and sponsors.
· Feasibility Assessments: The research GP will work with the research team to donduct detailed feasibility assessments, considering factors such as patient population, resources, recruitment strategies, and competing studies.
- Communication:
- Inform: Keep the research team and stakeholders informed about study progress, changes, and important updates.
- Involve: Engage the research team and stakeholders in decision-making processes and ensure their involvement in study activities.
- Connect: Facilitate effective communication between the research team, sponsors, and other stakeholders.
- Document: Maintain comprehensive documentation of oversight activities, decisions, and communications to provide evidence of PI/sub-PI (where relevant) involvement and ensure transparency.
- Presentation: Presentation of findings from research studies to research team, stakeholders and wider audiences where required.
- Oversight:
- Protocol Compliance: Ensure that the study is conducted in accordance with the approved protocol and regulatory requirements. Implement necessary amendments and ensure that all changes are systematically documented and approved.
- Delegation: Appropriately delegate study-related tasks to qualified team members and maintain a delegation log (if PI/sub-PI). Ensure that all team members are competent and adequately supervised.
- Valid Informed Consent: Obtain valid informed consent from study participants, ensuring that they fully understand the study and its implications.
- Safety: Monitor participant safety and report adverse events (AE/SE) as required. Assess causality and expectedness of adverse events.
- Data Integrity and Quality: Maintain high standards of data integrity and quality assurance. Implement quality control measures and ensure accurate and complete data collection.
- Study Conduct:
· Undertaking Principal Investigator or Sub Principal Investigator role in studies as required: including taking part in the training and mentoring support needed for this.
· Medical Involvement in Protocol Execution: eg eligibility screening, history taking, examination, investigations, procedures and prescribing (including IMPs) in line with study protocols. Providing medical leadership during studies. Interpretation of test results. Communicating medical aspects of the trials to patients.
- Feasibility Assessments: Conduct detailed feasibility assessments, considering factors such as patient population, resources, recruitment strategies, and competing studies.
- Recruitment Targets: Set and achieve recruitment targets, ensuring efficient study timelines. Implement strategies to maximize recruitment and minimize drop-outs.
- Systematic Changes: Implement systematic changes to study processes and maintain version control for study documents. Ensure that all amendments are approved and communicated to the research team.
- Caseload: Clinically manage clinical research caseload according to study protocols, maintaining patient safety, and consulting with study participants during study visits where required.
- Teamwork:
- Supervision and Support: Provide supervision and support to the research team, fostering a collaborative and positive research environment.
- Teamwork: Promote teamwork and effective collaboration among the research team and stakeholders.
- Best Practices: Lead by example and ensure adherence to best practices and ethical standards in research.
- Participation in and Attendance at Regular Research Team Meetings.
Professional Role
1. To ensure confidentiality is maintained at all times.
2. To be professionally accountable for actions and advice.
3. To be aware of training and competency assessment of medical students, foundation and GP specialist trainees and to participate in their training and competency assessment as required.
4. To participate in the training and competency assessment of other health care and non-health care professionals as required.
5. Participate in Continuous Professional Development.
6. Conduct Clinical Trial eligibility screening.
7. To attend Clinical Trial specific training course(s) to maintain and update knowledge including web based learning.
8. Any other reasonable duties as requested by the GP Research Lead and/or Director of Research.
Other Services
1. Support the establishment of additional clinical services that may need to be mobilised e.g. Travel clinics.
2. Ensure active engagement with GP Research Lead and Director of Research to ensure joined up working across the services.
3. From time to time, it may be necessary to support the CLH with delivery of clinical tasks as relevant to training, experience and competence.
4. Signpost any queries to the appropriate teams to support patient care.
5. Support the site preparedness for CQC inspections – and attend inspections to provide clinical assurance to the inspecting team.
6. Recognise personal limitations and refer to more appropriate colleagues where necessary.
7. Work collaboratively with multi-disciplinary team on site, CLH colleagues as well as other health and social care professionals across the system.
PERSON SPECIFICATION
Qualifications, Knowledge and Experience
Essential
MRCGP
Registered and licensed as a GP on the GMC register
On a primary care Performer’s List
Training in Good Clinical Practice certification (kept up to date) and other relevant certifications
Sound understanding of Research Governance (eg GCP)
Good IT Skills including competent use of Microsoft Tools
Desirable
Experience in clinical research and familiarity with regulatory requirements
Clinical Trial delivery in primary care
Competent with SystmOne
Skills
- Strong leadership and decision-making abilities
- Excellent communication and interpersonal skills
- Attention to detail and commitment to data integrity
- Ability to manage multiple tasks and prioritize effectively
- Proficiency in using research-related software and tools
The above list of job duties is not exclusive or exhaustive and the post holder will be required to undertake such tasks as may reasonably be expected within the scope of the post.
Requirements
Research GP
Benefits
NHS Pension
Modern office
Hybrid working
Free tea/coffee etc.
Cycle to work scheme
Life Assurance scheme
EAP
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