As clinical trials increasingly shift into community-based settings, general practices are becoming key players in research delivery. But executing trials efficiently requires more than good intentions—it demands the right team, in the right roles, with the right staff model, especially for GP practices transitioning into clinical investigational sites. For busy practices juggling patient care and research, close attention should also be paid to a well-designed staffing model to achieve success.
Why Staffing Matters
The success of a clinical investigational is dependent on the capability of its staff. Even with access to willing patients and simple study protocols, a poorly staffed site will struggle with recruitment, adherence to protocol, data quality, and regulatory documentation etc. On the flip side, a well-staffed site will run like a well-oiled machine—efficient, compliant, and highly attractive to sponsors.
The Challenge for GP Practices
GP practices entering clinical research face unique hurdles:
- Limited prior trial experience among practice staff.
- Workflow disruptions (Clinical Practice Vs. Research) if roles are poorly defined.
- Regulatory complexity (e.g., GDPR, GCP, NHS ethics).
- Resource constraints, including time and personnel.
Without a tailored staffing strategy, practices risk burnout, compliance gaps, and delayed trials.
Key Components of an Optimal Staffing Model
1. Define Core Roles
It is imperative to adapt traditional clinical trial roles to fit GP practice dynamics. Clinical trial roles can further be group into essential and supporting roles. When building an effective your clinical research team within a general practice, it is important to place prioritise these essential roles.
Essential role
- Principal Investigator (PI): Often a GP partner or senior clinician with trial oversight responsibilities. They will also be the primary point of contact for sponsors and regulators.
- Pro tip: GPs make excellent PIs due to their clinical acumen and community trust, but they must be fully supported administratively. PI must share administrative duties among partners to avoid overburdening one individual.
- Clinical Research Coordinator (CRC) or Research Site Manager: Depending on the complexity and number of trials, a dedicated coordinator can bridge the clinical and administrative arms of the trial, managing logistics and monitoring timelines.
- Pro Tip: CRCs or Research Site Manager often serve as the backbone of a successful trial. Ensure the role is held by appropriately qualified practice staff.
- Clinical Research Nurse (CRN) or Practice Nurse with Research Training: Responsible for patient recruitment, facilitating informed consent, study procedures, and sample collection.
- Pro tip: Flexible models may combine CRN duties with regular nursing hours to manage workload efficiently.
Support role
- Sub-Investigator: Support the PI in various tasks including patient recruitment, obtaining informed consent, performing study procedures etc.
- Data Manager: Leverage part-time staff or outsource to ensure accurate, timely data entry and monitoring
- Clinical Trials Administrator (CTA): Handles documentation, scheduling, filing of regulatory documents, and communication with sponsors. This role ensures the trial doesn’t grind to a halt due to paperwork delays.
- Regulatory Compliance Officer: The practice manager or a designated GP handling ethics submissions, approvals, and audits.
- Phlebotomist or HCA (if not covered by nursing staff): For blood draws, sample processing, and basic patient procedures.
Pro tip: The above role could also be managed by a Clinical Research Coordinator for newly set up research site.
2. Identify Staffing Models that best fit your General Practice.
Depending on the size of the research site (i.e., number of studies, operational set-up etc.), One of the models recommend below can be implemented
Model A: The “Embedded Team” Approach
- Key Feature: Dedicated staff roles for research only (e.g., full-time CRN, CTA)
- Best for: Practices running multiple trials or larger Phase II/III studies
- Benefit: High quality, faster recruitment, better sponsor relationships
Model B: The “Integrated Practice” Model
- Key Feature: Shared duties between existing practice staff and research responsibilities
- Best for: Smaller practices or first-time research sites
- Benefit: Cost-effective, smooth integration into daily practice operations
Model C: The “Hybrid Expansion” Model – Biopharmaal Consulting recommendation
- Key Feature: Begin with integrated roles, expand to dedicated hires as trial volume increases
- Best for: Growing sites scaling up their research portfolio
- Benefit: Risk-managed growth, tailored to funding and workload
Pro tip:
- Startup: Temporarily increase admin support for contracts and regulatory submissions.
- Recruitment: Assign part-time staff to screen patient databases and schedule visits.
- Active Phase: Rotate CRC duties among team members to maintain workflow balance.
3. Cross-Train Existing Staff
- Upskill GPs, nurses, and admin staff through GCP training, NIHR and industry (commercial sponsor) – specific workshops.
- Create hybrid roles (e.g., a nurse handling both patient care and trial assessments).
4. Leverage Technology
- Use NHS-linked EHR systems to identify eligible patients efficiently.
- Adopt eConsent tools and Electronic Data Capture (EDC) to reduce paperwork.
- Implement trial management software for real-time progress tracking.
5. Prioritise Compliance & Quality
- Conduct internal audits and mock inspections.
- Develop SOPs for common tasks (e.g., adverse event reporting).
6. Track Performance Metrics
- Monitor KPIs like patient recruitment rates, protocol deviations, and data query resolution times.
- Adjust staffing based on needs and bottlenecks (e.g., hiring a temporary CRC if recruitment lags).
Efficient clinical trial execution hinges on strategic staffing—not just hiring more people, but optimizing roles, training, and technology. For GP practices, this model unlocks new revenue streams, enhances patient care options, and contributes to groundbreaking research.
How Biopharmaal Consulting Can Help
At Biopharmaal Consulting, we specialise in helping GP practices establish themselves as clinical investigational sites. A core part of this transformation is building an optimal staffing model that balances regulatory compliance, cost-effectiveness, and smooth trial operations. Transitioning to a clinical trial site doesn’t require overhauling your practice. Our team supports UK GPs by:
- Designing bespoke staffing plans aligned with trial scope and practice size. we take pride in crafting staffing models that are scalable, cost-conscious, and tailored to the unique dynamics of each practice.
- Providing GCP training and ongoing regulatory support.
- Connecting practices with flexible talent networks (e.g., freelance CRCs).
Ready to transform your practice? Contact Biopharmaal Consulting to build a staffing model that works.