Specialized Roles for Clinical Trial Site Design

How to optimize trial site management

By Kelli Henry

As the design and operation of site management organizations evolve, so do the roles and relationships within the site management teams. Understanding the evolutionary process, its challenges and outcomes can give team members, sponsors and partners such as staffing firms valuable insights into the most effective ways to allocate responsibilities — now and in the future.

With this evolution comes new expectations on the part of sponsors for the process to be performed faster, cheaper and more efficiently. In the best of all worlds, this will be accompanied by increased standardization, allowing clinical research personnel and consultants to provide best practices from site to site and sponsor to sponsor. However, this is still a work in progress, and all involved must be able to adapt to differing methods and processes employed by each sponsor.

Elements of Success

A number of factors contribute to the success of a clinical trial, including organization, communication, use of technology and support for patient recruitment. According to a 2005 Thomson Center Watch survey of 612 investigative sites in the U.S., the single most important factor for success was organization and preparation. Well-trained monitors, good protocol design and effective communication were other significant factors. Let’s examine each of these:

Changing Roles in Site Management

Recognizing these success elements, let’s discuss specific outcomes for the organizational structure that can best accomplish them, and then discuss three roles that are well suited to achievement of these outcomes.

Broadly speaking, the most effective organizational structure will be scalable and accountable, providing roles that enhance consistency and quality. More specific outcomes include enhanced investigator loyalty (a key element given the alarming rate — as high as 50% — of investigators who either do not complete their first study or never conduct another trial), improved site productivity and establishment of an environment that ensures patient, site and employee retention.

Roles to be performed within this organization include territory development, full site management, trainers and administration. Sponsor companies and staffing firms, in their evaluation of the process, are now creating more specialized roles to increase efficiency and improve retention. The first of these is the site manager (SM).

The role of the site manager is a logical offshoot of improved technology. By changing from a paper-oriented monitoring force to a technology-enabled one, sponsors free their monitors to cultivate site relationships, discussing issues related to protocol conduct, patient enrollment and study results. By empowering site monitors, sponsors give them greater ownership in the development of the sponsor’s reputation at the site, creating a situation in which investigators enjoy direct and consistent interaction with the sponsor company.

Ideally, investigators will conduct multiple studies within similar indications and therapeutic areas and one SM will be assigned to all studies conducted by a single investigator. Site managers can thus become the primary point of contact for the site, totally aware of site performance levels, patient enrollment and contractual issues and organizational constraints — all of which will yield more timely decision-making abilities and a higher level of customer service.

Additionally, SMs will be responsible for study site start-up, maintenance, collecting and approving the required regulatory documentation, managing the budget and setting the payment schedule with the site. They will also identify the training needs of site personnel, provide guidance and conduct the necessary training post-investigator meeting. And, although current responsibilities will remain, such as provision of monitoring reports and management of all aspects of site performance, this model will allow SMs to use site visits to a greater extent to cultivate and/or enhance relationships with investigators and site staff.

Summarizing the new role of the site manager, we can identify the following key changes:


Success for SMs is based upon the performance of the sites for which they are responsible, measured in terms of continual improvement in the areas of timely enrollment, patient retention, investigator retention and willingness to participate in new studies, identification and utilization of new high-potential sites and overall productivity of assigned sites.

Ultimately, the energy and effort a site devotes to its level of participation in a given study is based on its loyalty and commitment to the sponsor company. By hiring and developing more skilled site managers, sponsors will build positive reputations, stronger relationships and thus more productive sites.

Specialized Role – Territory Development Specialist

Effective site selection is essential to the success of the clinical trial and we believe it requires a dedicated position that can complement the skills and knowledge offered by the site manager.

The territory development specialist (TDS) can focus on driving patient enrollment and enhancing patient retention, identifying and then leveraging best practices across sites. This position, particularly when augmented by the position of compliance & training auditor that we describe below, addresses four issues that have previously impeded the success of site managers:

Specialized Role – Trainer

Another valuable role on the regional monitoring team encompasses essential training components. Trainers support the SM and are responsible for conducting standard operating procedure training and training in areas including therapeutic, process, best practices and technology as well as new hire orientation for newly hired monitors.

Making sure site managers understand regulatory requirements can also fall on the trainer’s shoulders.

They provide answers and support to compliance questions on ICH GCP, SOPs, and regulations and guidelines. Management can also choose to use trainers to support the roll out of certain initiatives and processes.

Ultimately, trainers can act as a safety net for the site manager by ensuring all new and current members of the clinical trial are trained and all aspects of the SM’s role during the trial run smoothly.

Making the Roles Work

Recognizing the strong relationship of patient enrollment and retention to a study’s success, the sites most likely to benefit from the interplay of these three roles will be those that can maximize their potential for patient enrollment and retention.

Thus, SMs, TDSs and trainers will work together to evaluate and qualify prospective sites to target those with the highest potential for patient enrollment, using support software to identify the largest concentration of potential patient groups. By activating sites with a higher prospect pool,
they can decrease the patient enrollment period, saving time and money.

Training should focus on patient recruitment, relationship development skills and customer service strategies — critical skills for developing productive relationships with clinical sites. Creativity in recruitment — based on the site manager’s understanding of the therapeutic area, protocol, current standards of care, competing studies and the pool of prospective patients — will increase the likelihood of success.

The success of clinical trials is ultimately measured by the sponsor in terms of both process — drug development speed and cost advantages — and a successful return on investment after market launch. Both of these are closely linked to involvement of investigator physicians, and this is where the enhanced roles of site manager, territory development specialist and compliance & training auditor can yield positive results.

Although the actual number of physicians who participate as investigators in clinical trials is relatively low — fewer than 5% of all active physicians — they typically write more prescriptions later for the study drug and play an important role in influencing the prescribing behavior of other physicians.

Thus, building a positive and lasting relationship with investigators is paramount to the pharmaceutical company’s success. Focusing on customer service and dedicated resources not only strengthens the relationship between site and sponsor, but is also an investment that can pay off for the pharmaceutical company in the longer term.

Looking forward, the most successful partnerships between sponsors and staffing firms that provide SMs, TDSs and trainers will reflect a keen understanding of these changing roles as well as the development of the necessary recruitment, hiring, training and retention methodologies to make the positions effective. With these practices in place, the staffing partner will be able to recruit and retain the most qualified and experienced candidates who will then enhance clinical trial sites and improve sponsor results.

Kelli Henry is the compliance and training manager for the Roche Kforce Alliance. She is responsible for managing the compliance and training advisors who provide support to the members of the Alliance.  She can be reached at kelli.henry@roche.com.