Clinical Researcher—August 2023 (Volume 37, Issue 4)

SPECIAL FEATURE

Meghan Francis, MPH; Andrew Pucker, OD, MS, PhD

 

 

 

[Editor’s Note: The following presents a fictionalized scenario and details to illustrate career options worth considering in certain clinical research settings.]

Irene works at a large university as a research assistant in a multiple sclerosis laboratory, and she is finishing her Master’s in Public Health (MPH) degree. She has recently started looking for potential jobs as she nears graduation. Taking advantage of the university’s courses with the hope of bridging research and health outcomes, Irene is completing a six-month seminar series aimed at better understanding clinical and translational sciences. In this course, she learns about a position during a presentation on clinical research, called a clinical research coordinator (CRC), which sounds interesting to her because it merges patient interaction with clinical research. This position is also often called a study coordinator.

Irene has been focusing on biomedical research and epidemiology during her MPH coursework, and she is intrigued enough by what she hears during this lecture to reach out to the presenter, Dr. James, who is the Director of Clinical Trials at her university. Dr. James later offered Irene a CRC position in her research clinic. This simple inquiry about clinical research jump-started Irene’s career, and she has not looked back.

Turning Barriers to Bridges in CROs

Irene, like many others, lacked awareness of clinical research as a career opportunity. This specific issue is highlighted in a call to action from the Association of Clinical Research Professionals (ACRP) in its “Barriers to Bridges” white paper.{1} This paper likewise highlights the current battles contract research organizations (CROs) are facing. A CRO is a multi-service company that is contracted by a sponsor (a company managing or financing the clinical trial for drug or device development) to perform services needed for a clinical trial, such as clinical operations, data management, clinical site monitoring, biostatistics, and medical writing, amongst other potential services.

CROs ensure clinical trials are conducted using Good Clinical Practice (GCP), which is an international standard for conducting clinical research with human subjects, and CROs ensure that trials are performed efficiently while protecting patient safety while testing product efficacy. CROs also serve as a liaison between clinical trial sites (e.g., private practices, hospitals, and universities where clinical trials are performed), the sponsor, and trial vendors who supplement the capabilities of the CRO and sponsor (e.g., biological sample testing at laboratories, image analysis at independent reading centers, and pharmacovigilance [safety reporting]).

One of the most difficult hurdles with employee recruitment for CROs and clinical trial sites is that qualified candidates do not realize positions in clinical research are a potential option when searching for careers. More awareness of positions in clinical research to younger candidates interested in science, technology, engineering, and math careers is needed to make it accessible and appealing.{1} Potential candidates may be those who received a degree in health sciences but did or did not choose to go onto graduate school. Successful candidates display meticulous organization, proactivity, and effective communication with others. Persistence is also needed as candidates may need to apply to multiple job openings.

Clinical research is a highly specialized field in which, historically, candidates need at least two years of experience in clinical research before someone is willing to offer them an entry-level position. Thus, even if potential applicants are aware of the field, they may not fully understand how to obtain a position. Some CROs have developed comprehensive training programs to provide candidates with immersive “mock” training experience, such as a clinical research associate (CRA) training program for those who wish to monitor clinical trials as direct employees of sponsors, under contract as independent consultants, or as a CRO employee.

Bilodeau notes how CROs may invest in the training of less experienced staff to become CRAs through extensive workshops, mock simulations with constructive criticism and confidence building, in-field training, mentoring, and modules to develop soft skills, and that this contributes to bridging the gap of the need for experienced CRAs.{2}

Making the Leap

More often than not, the CRA position is not a starting point for a clinical research career, but there are a multitude of backgrounds that can result in a successful career as a CRA. Even as someone with a master’s degree and onsite research experience as a CRC, Irene found it extremely difficult to break into the specialized CRA role, which she learned about while working as a CRC in 2017, due to companies only wanting to hire CRAs with at least two years of experience in that direct role.

The pandemic has since forced many companies to reassess the way they are hiring CRAs and has spurred the above-mentioned training programs, yet the need for new CRAs has dramatically increased, possibly because employees are less interested in traveling in the most recent climate.{3} This is a particular issue with the CRA position, because many CRAs travel more than 50% of the time. Furthermore, sites are also facing staffing and retention challenges. This issue is highlighted in an Open Letter from the Society of Clinical Research Sites, which states clinical sites are facing 35% to 61% turnover rates for patient-facing staff. Further, sites report that it costs approximately six months of pay to train new clinical staff, who are often less-experienced than their predecessors, so it takes longer before they can independently function in their new role.{4}

As a new CRC working in ophthalmology with Dr. James, who is providing hands-on mentorship in the therapeutic area, Irene gains valuable experience learning how to properly perform informed consent, process lab samples, submit ethics documents to the institutional review board, follow protocol procedures, administer questionnaires, collect and file regulatory documents, resolve monitoring visit findings, report adverse events and protocol deviations, and enter data in source (typically the original paper recording form) and the electronic data capture system. Irene enjoys her work because she has patient interaction and is involved downstream in bringing cutting-edge ophthalmology technology safely to the market.

After two years, Irene has worked on a multitude of studies in different phases and therapeutic indications and is interested in expanding her career; one of the CRAs assigned to her site encourages her to apply for a CRA position at an ophthalmology CRO with a CRA training program. Intrigued by the idea of traveling the country and enhancing site relationships, Irene interviews and accepts a CRA position, and enters the CRA training program. By the time she has completed the program, she has learned how to perform different types of trial visits (e.g., pre-study, site initiation, interim monitoring, and closeout), review data via source data verification with medical records and source, issue and resolve queries, perform investigational product accountability, and complete simulated monitoring visits and associated reports to document significant findings as well as action items.

Upon completion of the training program, Irene is assigned to monitoring duties on two sponsored studies—one related to dry eye and the other to contact lenses—and communication with site staff, the clinical study managers, and project directors is an integral part of her new job. The CRA also ensures site staff have proper training and credentials as well as ensuring up-to-date equipment and lab certifications.

Since ophthalmology is a niche therapeutic area, Irene’s previous experience as a CRC helps acclimate her to the position, as she is familiar with looking at medical records and source for unique ophthalmology assessments. The dry eye trial uses a Central Reading Center to certify photographers and assess image quality, and Irene’s background in ophthalmology allows her to successfully train sites on the specific processes for the imaging protocol and its image certification requirements. Irene excels as a CRA because she is empathetic, self-motivated, accountable, and punctual with meeting deadlines.

Career Growth at a CRO Post-Pandemic

A few years (any many hotel stays and flights) later, Irene seeks a position with less travel and the ability to work fully remote from home, reflecting a trend which can benefit both employees and employers. The Council for Disability Awareness reports that careers without remote work options experienced a 50% increase in the usage of sick time during the pandemic, but remote work options “experienced lower than average increases,” which may help companies decrease costs related to employee absence.{5} Imani Dunbar from LinkedIn reported that before the pandemic, 2% of jobs listings on LinkedIn were remote, but it is currently at 15%, and the flexibility is intriguing to candidates.{6} Rumanance reports that remote work allows for more flexibility from CROs when hiring talent because geography is no longer a limiting factor.{7}

Looking for a permanently remote and work-from-home position, Irene successfully transitions to a clinical study manager role (sometimes called a clinical trial manager) at an ophthalmology CRO. Study managers largely focus on customer service deliverability to the sponsor, and ensure that trials run smoothly by identifying, resolving, or escalating issues involving trial timelines and deliverables. Study managers display critical thinking and creativity while following the protocol and GCP. In trial start-up, they are responsible for overseeing feasibility, site selection, and site start-up, including managing contracts, budgets, and developing trial documents (plans, logs, manuals, etc.). Study managers can often leverage their site relationships to try to identify the potential first-subject-in (first subject enrolled), and the strong relationship may assist with boosting subject enrollment at a site.

Study managers must be strong communicators because they are interfacing with the sponsor, trial team members, site leaders, and vendors. The background requirements for the role include at least five years of clinical research experience and a bachelor’s degree in a health-related field, besides which, CRA experience is preferred along with a strong foundation for GCP, regulatory, and clinical operations procedures.

Study managers also work directly with project directors who provide high-level oversight of the trial, including scope of work, deliverables, and related activities. Project directors often collaborate with other departments to improve inter-departmental functions, oversee trial budgets, review project health, and strive for customer satisfaction while also being the point of escalation for clients. They have typically at least seven years of clinical research experience and a bachelor’s degree in a related field. Irene hopes to one day become a successful project director, and strives to continue to hone her project management skills.

Conclusion

While this article mainly focuses on career progression in clinical operations at a CRO, there are many other entry-level positions to be considered in clinical research, such as in the areas of patient recruitment or navigation, medical writing, data management, biostatistics, reading centers, clinical photography, and regulatory compliance. We should also note that although bachleor’s and master’s degree programs in clinical research can be found at many institutions, there is no single, clear-cut path or set of skills required to begin a career in this growing field. Companies are furthermore beginning to train more employees from scratch to allow for lateral moves from other professional fields. Thus, it may be easier than ever to begin a career in clinical research at a CRO, and if CROs are investing in their employees, then it could be a welcoming and rewarding career path for new prospects to the field.

References

1. Association of Clinical Research Professionals. 2022. Barriers to Bridges: Addressing the Urgent Need for a Diverse, Research-Ready Workforce Within the Clinical Research Profession. https://acrpnet.org/barriers-to-bridges-addressing-the-urgent-need-for-a-diverse-research-ready-workforce-within-the-clinical-research-profession/
2. Bilodeau K. 2022. As Clinical Trials Face a Hiring Crunch, Here’s How Research Organizations Can Pivot. https://www.pharmavoice.com/news/clinical-trial-staffing-hiring-shortages/643562/
3. Society of Clinical Research Sites. Tackling the Great Resignation and Burnout in Clinical Research. https://myscrs.org/resources/tackling-the-great-resignation-and-burnout-in-clinical-research/
4. Society of Clinical Research Sites. An Open Letter to Sponsor and CRO Colleagues Regarding Workforce Retention and Inflationary Pressures Affecting Clinical Trial Sites. https://myscrs.org/workforce-challenges-letter/
5. Council for Disability Awareness. 2021. What’s Happening: New Research Reveals Remote Workers Report Lower Employee Sick-Time Rates. https://www.globenewswire.com/en/news-release/2021/10/27/2322135/0/en/New-Research-Reveals-Remote-Workers-Report-Lower-Employee-Sick-Time-Rates.html
6. Dunbar I. 2022. With Uncertainty on the Horizon, Remote Roles Have an Additional Value: Workforce Diversity. https://www.linkedin.com/business/talent/blog/talent-acquisition/with-uncertainty-on-the-horizon-remote-roles-have-an-additional-value-workforce-diversity#:~:text=Prior%20to%20the%20pandemic%2C%20just,the%20interest%20of%20the%20workforce
7. Remunance. 2023. Clinical Research Organization (CROs): It’s Effective Switch to Remote Working. https://remunance.com/blog/clinical-research-organizations-effective-switch-to-remote-working/

Meghan Francis, MPH, (Meghan.Francis@lexitas.com) is a Clinical Study Manager at Lexitas Pharma Services and has held several positions both at CROs and clinical research sites, such as Associate Study Manager, CRA, and CRC roles. Prior to the clinical research industry, she worked as a laboratory benchwork scientist at the University of Iowa and University of Alabama at Birmingham. She works remotely in the Greater Boston Area.

Andrew D. Pucker, OD, MS, PhD, (Andrew.Pucker@lexitas.com) is the Senior Director of Clinical and Medical Sciences at Lexitas Pharma Services and a former faculty member at the University of Alabama at Birmingham. He has received research or consulting support from Alcon Research, LLC, Art Optical, Euclid Systems, HanAll Biopharma, and Haymarket Media, Inc. in the past year.