By: ABRS- Academic Team
Introduction
The clinical research industry is facing one of its most pressing challenges: building and sustaining a skilled workforce. As clinical trials expand globally and grow in complexity, the demand for experienced professionals such as Clinical Research Associates (CRAs), project managers, and study coordinators continues to rise. However, high turnover rates and limited professional development opportunities are making it increasingly difficult to maintain the stability that trials require.
At ABRS (Advanced BioResearch Solutions, Inc.), we recognize that talent is the cornerstone of every successful clinical trial. The purpose of this article is to explore how the Functional Service Provider (FSP) model goes beyond filling staffing gaps. It provides a strategic framework to support recruitment, strengthen competencies, and ensure long-term retention. By focusing on people, ABRS aims to demonstrate how sustainable talent management can drive quality, compliance, and innovation in clinical research worldwide.
The Talent Shortage: Scope and Consequences
The shortage of qualified professionals in clinical research has been building for over a decade, but the COVID-19 pandemic and its aftermath accelerated the crisis. Many experienced CRAs, coordinators, and project managers left the industry due to burnout or sought more flexible career paths, creating a widening gap between the growing demand for trials and the availability of skilled staff.
Recent reports show the magnitude of the challenge:
High turnover and vacancy rates: According to Clinical Leader (2023), more than 70% of clinical trial sites report that staff turnover has directly delayed study timelines.
Workload pressures: Applied Clinical Trials (2022) highlights that CRAs often manage an average of 10–12 sites simultaneously, leading to reduced monitoring frequency and higher stress.
Global competition for talent: Biopharma, biotech startups, and digital health companies are recruiting from the same limited talent pool, intensifying competition and increasing salary inflation.
Skills mismatch: Traditional academic training often does not align with the evolving requirements of decentralized trials, digital platforms, or advanced data analytics. This creates additional training needs for new hires.
The consequences go beyond staffing metrics. Staff shortages directly impact the quality and safety of clinical trials:
Delays in trial initiation and slower patient recruitment result in longer time to market for new therapies.
Reduced oversight increases the risk of protocol deviations, non-compliance, and data integrity issues, which can compromise trial validity.
Overburdened staff are more prone to errors, which can jeopardize both patient safety and regulatory acceptance.
As noted by Clinical Trials Arena (2023), the staffing crisis has become a strategic risk for sponsors and CROs alike. It threatens not only operational efficiency but also patient trust and the credibility of clinical research as a whole. This is where innovative workforce solutions, such as the FSP model, gain importance—not only as a resourcing strategy but as a pathway to long-term sustainability in clinical operations.
How FSP Models Support Talent Development
Functional Service Provider (FSP) models are increasingly recognized as more than just a staffing solution. By integrating professional development strategies into their operations, FSPs play a central role in building sustainable talent pipelines for clinical research. Unlike traditional outsourcing, where staff may feel disconnected from long-term growth opportunities, the FSP approach emphasizes continuity, training, and role specialization.
Structured Recruitment and Onboarding
One of the key advantages of the FSP model is its ability to implement structured recruitment pipelines. Instead of relying solely on ad hoc hiring, FSPs can establish standardized processes that align with both sponsor needs and professional competency frameworks. According to Clinical Trials Arena (2023), FSPs are better positioned to screen candidates not only for technical skills but also for regulatory knowledge and adaptability to complex global trials. This results in higher quality placements and reduced turnover.
Continuous Training and Upskilling
Professional development does not end at onboarding. FSPs often offer ongoing training programs, mentorship initiatives, and competency-based assessments. For example, a 2023 study in BMC Medical Education highlights how “train-the-trainer” models are effective in sustaining long-term workforce competence in clinical roles (BMC Med Educ, 2023). Many FSPs embed these models, ensuring CRAs and project managers stay up to date on evolving regulatory standards, digital trial technologies, and patient engagement strategies.
Role Flexibility and Career Growth
Flexibility is another core strength. FSP models allow staff to transition between roles or functions—moving from monitoring to project management, or integrating exposure to pharmacovigilance and data management. This role diversification offers professionals opportunities to expand their skill sets and reduce the monotony that often leads to burnout. PPD (2023) emphasizes that such career pathways not only improve retention but also enhance the collective expertise delivered to sponsors.
Organizational Belonging and Engagement
Finally, FSPs foster a sense of belonging by embedding professionals into sponsor teams while providing the stability of being part of a larger service organization. This dual identity—part of a sponsor project and part of the FSP workforce—helps employees feel supported, valued, and recognized, increasing overall job satisfaction.
Retention Strategies under FSP: What Works
One of the greatest challenges in clinical research today is not only finding qualified professionals but ensuring they remain engaged and committed in the long term. High turnover has become a recurring issue, particularly among Clinical Research Associates (CRAs) and project managers, where workload, stress, and limited career visibility often push talent to seek opportunities elsewhere. The Functional Service Provider (FSP) model offers a structured framework that can significantly improve retention by fostering professional growth, stability, and recognition.
A central strategy lies in creating clear career pathways. When employees understand how their role can evolve over time—whether through senior CRA positions, team leadership, or cross-functional opportunities—they are more likely to remain invested in their organization. According to PPD (2023), transparent promotion structures and competency-based evaluations are among the most effective mechanisms for motivating clinical professionals to stay. Employees who can visualize their future are less prone to burnout or disengagement.
Another critical factor is the cultivation of a supportive work environment. Clinical research is a demanding field where deadlines are tight and regulatory oversight is rigorous. FSP models help mitigate this by embedding staff within sponsor teams while ensuring continuous organizational support. Professionals report higher satisfaction when they feel both integrated into sponsor operations and supported by a parent organization that invests in their well-being. Recent findings published in Frontiers in Medicine (2024) emphasize that supportive team dynamics, workload balance, and flexible working arrangements (such as hybrid or remote monitoring) are decisive in reducing attrition rates.
Recognition and professional validation also play a pivotal role. Simple initiatives such as certification programs, regular feedback sessions, and acknowledgment of contributions can boost morale and reduce the risk of turnover. FSPs, by design, are able to implement recognition programs across projects, ensuring professionals feel valued not only by the sponsor but also within the broader service organization.
Lastly, alignment with professional standards reinforces retention. By embedding frameworks like the Joint Task Force for Clinical Trial Competency, FSPs ensure staff development is recognized globally and aligned with industry benchmarks. This not only strengthens professional identity but also provides reassurance to employees that their skills are transferable, relevant, and future-proof.
In short, effective retention strategies within FSP models are built around three interconnected pillars: career growth, workplace support, and professional recognition. When implemented together, these strategies transform the employee experience, reduce costly turnover, and ultimately safeguard the quality and continuity of clinical trials.
Conclusion:
In an era where talent has become one of the most critical assets in clinical research, the ability to attract, develop, and retain professionals is a defining factor for success. The FSP model provides a framework that addresses these challenges directly, offering both sponsors and professionals a pathway to sustainable growth.
At ABRS (Advanced BioResearch Solutions, Inc.), we believe that investing in people is at the heart of delivering high-quality, compliant, and efficient clinical trials. Our FSP model is designed not only to provide operational flexibility and expertise but also to create environments where clinical research professionals can thrive. By aligning strategic oversight with continuous professional development, ABRS ensures that every trial benefits from a dedicated, skilled, and engaged workforce—because when talent is supported, science moves forward.