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About the Role

This part-time role, two days per week, involves supporting the research team in identifying and developing a portfolio of research projects. Key responsibilities include conducting feasibility assessments, ensuring protocol compliance, obtaining informed consent, monitoring participant safety, and maintaining data integrity. The role also requires effective communication, documentation, and providing medical leadership in study execution.

Responsibilities

• Identify potential studies that align with the site's capabilities and patient population.
• Develop and maintain a diverse portfolio of research projects.
• Conduct detailed feasibility assessments, considering patient population, resources, recruitment strategies, and competing studies.
• Keep the research team and stakeholders informed about study progress, changes, and important updates.
• Engage the research team and stakeholders in decision-making processes.
• Facilitate effective communication between the research team, sponsors, and other stakeholders.
• Maintain comprehensive documentation of oversight activities, decisions, and communications.
• Present findings from research studies to research team, stakeholders, and wider audiences.
• Ensure the study is conducted in accordance with the approved protocol and regulatory requirements.
• Appropriately delegate study-related tasks to qualified team members and maintain a delegation log.
• Obtain valid informed consent from study participants.
• Monitor participant safety and report adverse events.
• Assess causality and expectedness of adverse events.
• Maintain high standards of data integrity and quality assurance.
• Implement quality control measures and ensure accurate and complete data collection.
• Undertake Principal Investigator or Sub Principal Investigator role in studies as required.
• Perform medical involvement in protocol execution, including eligibility screening, history taking, examination, investigations, procedures, and prescribing.
• Provide medical leadership during studies and interpret test results.
• Communicate medical aspects of trials to patients.
• Set and achieve recruitment targets, ensuring efficient study timelines.
• Implement strategies to maximize recruitment and minimize drop-outs.
• Implement systematic changes to study processes and maintain version control for study documents.
• Clinically manage clinical research caseload according to study protocols.
• Provide supervision and support to the research team.
• Promote teamwork and effective collaboration among the research team and stakeholders.
• Lead by example and ensure adherence to best practices and ethical standards in research.
• Participate in and attend regular research team meetings.
• Ensure confidentiality is maintained at all times.
• Be professionally accountable for actions and advice.
• Participate in the training and competency assessment of medical students, foundation and GP specialist trainees.
• Participate in the training and competency assessment of other health care and non-health care professionals.
• Participate in Continuous Professional Development.
• Conduct Clinical Trial eligibility screening.
• Attend Clinical Trial specific training courses.
• Undertake any other reasonable duties as requested by the GP Research Lead and/or Director of Research.
• Support the establishment of additional clinical services.
• Ensure active engagement with GP Research Lead and Director of Research.
• Support the CLH with delivery of clinical tasks as relevant to training, experience and competence.
• Signpost any queries to the appropriate teams to support patient care.
• Support site preparedness for CQC inspections and attend inspections.
• Recognise personal limitations and refer to more appropriate colleagues where necessary.
• Work collaboratively with multi-disciplinary team on site, CLH colleagues, and other health and social care professionals.

Requirements

• 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 (e.g. GCP)
• Good IT Skills including competent use of Microsoft Tools
• Experience in clinical research and familiarity with regulatory requirements (Desirable)
• Clinical Trial delivery in primary care (Desirable)
• Competent with SystmOne (Desirable)

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

Location

• Hybrid working

Work Type

• Part time
• Hybrid working

Benefits

• NHS Pension
• Modern office
• Free tea/coffee etc.
• Cycle to work scheme
• Life Assurance scheme
• EAP