Creating a pool of high-quality CRA talent

Several industry-leading biopharma companies needed the support of Clinical Research Associates (CRAs) as they entered the early development of clinical trials for oncological therapies. Our clients chose to partner with ICON, — the market leader in Functional Service Provision. Our proven ability to prepare clinical trials for success, as well as our extensive experience in constructively managing relationships with clinical sites, and in protocol design and early trial development equipped us for a successful outcome. Our early development CRAs’ reputation for being highly proficient in clinical trial start-up, from preclinical through Phase 1, was a major attraction for them.

The enormous demand for early development CRAs had skyrocketed, rapidly outpacing availability. In addition, since each CRA is typically dedicated to a single client, the number of CRAs free to take on new requests was limited. These challenges, coupled with the misconception that Early Development Oncology (EDO) CRAs required 10 years’ experience, had greatly increased the cost of resources and limited the candidate pool, particularly for rapidly growing programs.

Our goal was to dramatically increase the number of available EDO CRAs in an expedited time-frame while ensuring quality and competency, so that we could keep up with the ever increasing demand for their services. As a result, we needed an approach that enabled more people to become EDO CRAs, while also ensuring that any new EDO CRAs would have the requisite skills to meet our high expectations for the position.

We created an accelerated training program to establish a pathway for individuals with the right competencies, skills and background to become strong EDO CRAs. Trainees were enrolled in a curriculum to expedite their knowledge of the EDO CRA landscape and to prepare them to successfully manage their own clinical sites. The key components of this program were:

1. Real world workshops. Potential EDO CRAs focused on building technical skills in addition to developing and enhancing competencies that are crucial to work in this fast-paced complex environment. They completed specialised training in areas such as Oncology, Haematology, Cell and Gene Therapy Academy through ICON. To ensure that each CRA had a thorough understanding of the core competencies, passing grades were mandatory to proceed.
2. Shadowing EDO CRAs on site. Leveraging the proficiency of our experienced clinical support staff, trainees shadowed EDO line managers and CRAs to gain practical experience on site. Working in small groups, trainee EDO CRAs developed first-hand knowledge of clinical site operations, with an emphasis on cultivating strong site relationships through understanding the site’s challenges and perspectives working in the EDO trial environment. This experience provided them with the ability to, in time, manage their own clinical trial sites and establish the site relationships needed for a productive study.
3. Ongoing on-the-job training. Even after assuming independent clinical site management, CRAs were given continued training as well as enhanced oversight via EDO line manager (LM) with a lower ratio of CRAs to LM. We encouraged ongoing collegial support, mentoring, process improvement through shared and independent learning to continue honing their skills. Additionally, we provided opportunities, such as regular quality assurance meetings, to support continuous learning and development.
4. Team Empowerment. EDO CRAs were empowered to lead discussions and identify risks and Plans of Action (POAs). SSU CRAs were successfully implemented in EDO to help increase on site focus and delivery despite the challenging COVID-19 environment (decreasing SDV backlogs and staying ahead).
5. Hiring Ahead. Less experienced CRAs with good site management skills were appointed to backfill for high performing CRA II or Sr. CRA in Late Phase with the aim of building a sustainable EDO staffing pipeline. Increased LM infrastructure dedicated to support Early Development oversight

By establishing a comprehensive training program that allows CRAs to develop into EDO CRAs in a few months, we built a significantly larger cohort of high-quality talent who were not only passionate about the science, early development and protocol design, but also gained the necessary experience to effectively manage relationships with clinical sites on these complex trials. This also allowed a balance of experience in the EDO team and eliminated the perceived notion that EDO CRAs need to have over a decade of experience.

Through consistent career support, we ensured improved retention of CRAs. Our clients also directly benefited from this increased availability of early development CRAs. The resulting enhanced site relationships consistently drove improved site performance, enrolling more patients in studies and, in some cases, reducing the number of required clinical trial sites.