Clinical Researcher—August 2021 (Volume 35, Issue 6)

PEER REVIEWED

Jerry M. Stein, PhD, ACRP-CP, ACRP-MDP, FACRP; Suheila Abdul-Karrim, CCRT, CCRA, ACRP-MDP, FACRP; Ernest Allen

The model has changed. Millions of people have exited full-time positions to work as independent contractors (ICs) in hundreds of industries. Experts say it is better for the economy. Do I care? Or what if I really need to know whether it is best for me, but it’s too soon to know? This article provides guidance on career choices, essential business practices, and tools for ICs involved with clinical research to help you survive while working under this competitive model.

Who Are Independent Contractors?

For the purposes of this article, independent clinical research contractors include any clinical monitor, clinical project manager, statistician, medical monitor, data manager, and medical writer hired for a specific project or time period and not dedicated on a long-term basis to one employer.

If you fit into any of these job titles and if your relationship to your employer matches this situation, congratulations! You have joined a growing segment of freelance professionals. In addition, you are now a small business owner with one employee: you. You are responsible for everything; there are no more support services down the hall or a phone call away. This includes the business development (finding clients), legal (contract negotiations), payroll and benefits (taxes, 401(k)), information technology (equipment, help desk), purchasing (office supplies, toner cartridges), and insurance (liability) departments. It is all you.

While the change from employee to contractor is often an individual decision, there have been significant changes across the entire workforce. A U.S. government study estimated 22% of workers received income as ICs, with the largest growth during the 2001 to 2016 period occurring among individuals identified as primary earners.{1} Thus, this is not just a “side-hustle” phenomenon among secondary earners. The same report found that the largest number of ICs (both men and women) were in the “professional, scientific, technical” sector followed by the “healthcare and social assistance” sector—two categories that likely include clinical monitors, study coordinators, and other clinical researchers. However, specific statistics regarding the number of clinical research ICs could not be found.

Forty years ago, most large sponsors employed everyone necessary to discover, test, manufacture, market, and support new drugs and medical devices. This A-to-Z approach required a long-term commitment to lots of employees and entailed significant financial risk to the companies.

Prominently beginning in the 1990s, the industry experienced downsizing that was triggered by economic downturns, mergers, and new corporate strategies.{2–4} Today, a large portion of research and development risk has been transferred to independent clinical contractors and small companies. In various forms, employees who traditionally worked for sponsors are now either employed by contract research organizations (CROs)—some embedded at large sponsors—or hired as contractors directly from a marketplace filled with ICs.

The required workforce expands and contracts using individuals who serve on-demand in response to additions or losses of contracts, projects, or changes in scope. Many companies only hire contractors when there is a high probability that the company will be paid or will successfully develop a new product.

In some cases, hiring an IC with unique expertise or skills is essential for project success. In other instances, hiring the IC only occurs when internal resources are limited and it would be risky to hire full-time, “permanent” employees. It is not too dissimilar to situations in which sponsors employ investigational study sites on an as-needed basis. However, while income from clinical studies is typically a side business for most sites outside academic medical centers, working for a sponsor is the primary source of income for most ICs.

What Are the Benefits of Being an Independent Contractor?

There are significant financial and non-tangible benefits to being a clinical IC (see Figure 1) and many of these features have been previously reported.{5–7} Foremost is control of your schedule. While contracts and teams can significantly vary, it is often the case that a strict 9-to-5, mandatory schedule is not an expectation of most contract assignments. Although 50- or 60-hour work weeks are not uncommon, these high-pressure periods are often transitory, predictable, and may be voluntary.

Figure 1: Advantages of Being an Independent Contractor

Flexibility
Getting to choose projects
Not getting caught up in company/office “politics”
Working from your own office where YOU control the environment
A wider range of experiences in different phases of clinical trials, with different therapeutic areas and at different companies

The contractor has the benefit of focus, flexibility, and choice. Being a contractor liberates you from many meetings that are not specific to your immediate job responsibilities and allows more time to focus on your assigned project. For parents with young kids, the work-life balance can be much better: drop the kids off at school, work six hours, pick up the kids, attend after-school activities, put the kids to sleep, and work some more when the house is quiet. For those with elderly family members, work can be planned around their treatments and schedules.

Contractors working across time zones can plan personal chores around team meeting schedules. Planning a two-week, international vacation? While there are no paid vacations, you can adapt by working longer hours in advance, delegating key responsibilities to other team members while you are unavailable, and/or refusing to take on an assignment that creates a conflict. The key to success is maintaining good communication with the company that hired you and the entire team. Almost every obstacle has a work-around.

There are also significant emotional benefits when you are not dependent on one supervisor or employer. You may realize a significant increase in self-esteem. You will likely develop significant pride in being a self-sufficient, independent business owner. Finally, you get to say “no, thank you” much more often. Perhaps anticipated, project-related air travel is too extensive. Perhaps you expect database lock pressures will be too much, the protocol too boring, or the therapeutic area beyond your comfort zone. Perhaps a better opportunity is on the horizon. Saying “yes” or “no” is your choice.

Finally, the existence of a significant number of clinical ICs has a particular benefit in the age of COVID-19 and in anticipation of future epidemics. While many employers faced challenges moving their employees from central offices to home settings, the ICs were already working from home offices and were ready to go,{8} which was a win-win for both contractors and sponsors.

Money Matters: Income

Improved compensation has been cited as one of the reasons individuals aspire to change from traditional employment to contracting.{6} The authors of the current article caution that this is not a guarantee—especially for newcomers.

The first step is a smart negotiation strategy, including knowing your marketplace value. How much are companies currently paying someone with your set of skills and experience? Can you justify a higher rate of pay by promising better responsiveness, efficiency, or skills?

When negotiating your compensation terms, remember that the company does not have to provide benefits frequently paid to so-called permanent employees (e.g., health insurance, disability, paid time off, and retirement). Traditional, full-time employee salaries are often 60% to 80% of total compensation budgets. Thus, a contractor’s higher hourly rate of pay is somewhat misleading.

Of course, in a competitive marketplace, you may decide to sell your services for significantly less than your peers in order to more easily land a contract. However, you may regret the decision with every hour you add to your timesheet, and your perceived value to this employer will be forever diminished.

Developing a network of peers has an impact on your compensation and job satisfaction. Networking—in person or electronically—is not simply a social function. Information about customary compensation, as well as common job expectations, is often only available through word-of-mouth sources. This will require an investment of your time. Professional meetings and other educational opportunities are also excellent forums for learning your value.

What About Taxes and Insurance?

Although a contractor’s income is generally higher compared to that of a full-time employee, you must be prepared to pay expenses and for financial surprises to pop up. The category of anticipated expenses includes insurance (general liability), income taxes (U.S.), value-added taxes (in some international markets), office supplies, travel considerations, professional dues, and training events.

Taxes vary from country-to-country and state-to-state. We will concentrate on the U.S. tax situation for simplicity, recognizing that the vast majority of our readers reside in the U.S. If you are paid as an IC, the company that hired you will typically not withhold federal, state, or local taxes. These tax payments are your responsibility, and some must be paid quarterly to avoid penalties. This requires planning and discipline.

Contractors must also pay for their own medical insurance and consider their options for paying for dental and vision care services. Planning for a comfortable retirement requires lots of time and, often, some short-term sacrifices. Finally, not all companies pay promptly; receiving a check 30 or 60 days after submission of an invoice is not unusual.

Most major companies require clinical ICs to have professional liability insurance, and some require workman’s compensation insurance. Premiums will vary with your role and responsibilities. For example, medical writers frequently document actions that have occurred already and are outside their control. Therefore, liability insurance (e.g., errors and omission insurance) for medical writers should be relatively inexpensive.

In contrast, if you are making decisions that directly impact the health of patient volunteers, higher premiums may be required. Although the chances of being sued are very small, securing these type of insurance policies is a common requirement based on our experience. Companies often require a minimum dollar level of insurance, and you must decide on your tolerance for risk. If you are successful and, hopefully, your net worth has increased, your risk tolerance may change. You may have more to lose if sued and might be considered a larger target for a lawsuit.

Individuals with higher net worth should consider umbrella liability insurance to economically protect their assets. The highest risk to your income stream might be your health. Health insurance might pay your medical bills, but will not feed your checkbook. A disability insurance policy will provide a portion of your lost income when you are unable to work under certain conditions.

Finally, setting up a limited liability company (LLC) or the equivalent will help separate your personal finances from your business activities. The Internal Revenue Service and your accountant will thank you.

What is Considered a Business Expense?

Deducting legitimate business expenses from your gross business income is allowed and is essential for your business to survive. The list of business expenses is extensive and includes, but is not limited to travel (air, automobile mileage, lodging, out-of-town meals), home office (toner, paper, office supplies, telephone, internet), professional dues, payments to sub-contractors, insurance, and continuing education. Maintaining certification through ACRP or other professional organizations is also an expense. Deduct it!

Itemizing business expenses also requires tools and discipline. Keep a log (hard or electronic copy) on everything you spend related to the business. Be sure to document a date and business reason for all expenditures. You should open a business checking account and obtain a credit card to use exclusively for business expenses.

While you might want to hire a bookkeeper and/or an accountant, Quickbooks and TurboTax are simpler to use when compared to reading standard operating procedures or regulatory documents. Of course, the authors of this article are not accountants or tax experts. Please consult with your Certified Public Accountant or the government tax office concerning all tax issues.

What Are Helpful Business Development Strategies?

If you are new to clinical research, your chances of finding a well-paying contract situation will be limited. Competition abounds and sponsors are looking for maturity, education, and experience in hopes of minimizing risk to their projects. While there are no firm, industry-wide education or experience requirements, professional certification expectations, or government-mandated qualifications, most sponsors are looking for individuals with three to five years of experience working for established companies.

Certifications (e.g., the ACRP-Certified Professional [ACRP-CP]) and academic/clinical training achievements (e.g., earning an RN, PA, MD, or PhD) offer advantages but are not guarantees of being taken seriously as an IC. Exceptions might include unique educational backgrounds, experiences, and therapeutic area expertise.

Someday, when you have a proven track record, clients will reach out to you spontaneously through word-of-mouth and there will be lots of repeat business Someday, you will be able to say “no” when approached to accept a job with a rate of pay lower than you expected or a project with unrealistic timelines. You might be able to pick your next employer/client from among several who are hoping to work with you at the same time (see Figures 2 and 3). However today, especially if you are just starting out, it is more likely that you will say “yes” to some unfavorable job offers. Building your experience and reputation is your short-term goal. Be careful not to over-commit, and only take on what you know you can manage and deliver on-time in a quality manner.

Figure 2: Picking Your Employer/Client

Big clients will probably:

Know what they want, and your voice may not be heard
Be less flexible on all matters (contracts, processes, time)
Have a larger team
Have established standard operating procedures and processes in place
Have more stringent continuing education requirements
Pay more slowly

Small clients will probably:

Let you influence their decisions to a greater extent
Have more flexibility on all matters
Have a smaller team
Have no or fewer standard operating procedures or processes
Have fewer continuing education requirements
Pay more quickly

Figure 3: Key Questions to Ask About a Proposed Clinical Project

Where is the client located? Does the client speak your language?
- This may impact communication and travel expectations.
Who will be your contact point with the client?
- A team? An individual?
When are periodic meetings and written reports required?
- Good communication and knowing expectations are essential.
How soon after an invoice is received is payment processed?
What is the turnaround time for reimbursement of expenses?

Where Do You Look for Jobs?

Our experience indicates that submitting your resume to most large staffing services will not lead to a job. It will be tempting to respond to every advertisement for a monitor, study coordinator, or other position. Unfortunately, each recruiter receives hundreds of resumes or CVs, and the odds are against you.

It is highly likely that your responses to too many job postings will simply consume your time, elevate your hopes, and lead to frustration. Occasionally, you will get a positive response—a phone call from the agency, human resources department, or hiring manager—but not very often. This is a classical intermittent, positive-reinforcement regimen that is strongly addictive, similar to putting coins in slot machines. Do not do it!

There are superior strategies for finding jobs that are much more productive and less frustrating (see Figure 4). By far, the best path to employment involves your network: business colleagues, ex-supervisors, principal investigators, site personnel, friends, and family. Personal referrals significantly influence the decisions of hiring managers and cultivating them is a highly recommended practice. Attend meetings, contact individuals employed in positions similar to what you are seeking, and get out there to “press the flesh” in person or virtually.

Figure 4: Business Tools, Tips, and Strategies

Don’t put all your eggs in one basket. Have two or more clients (just in case!)
Be flexible—clients like someone who is willing to adapt or accommodate.
Be disciplined—especially when working from a home office.
Identify services you will need, including to:
- Develop a webpage
- Develop one or more CVs
- Plan your office supply needs
- Build a network, both in person and through social media (LinkedIn, Facebook, Twitter)
Always look ahead to the next job
- Friends, friends, friends (essential)
- Professional recruiters and job post sites (worthless?)
- References

What Are the Disadvantages of Being an Independent Contractor?

Being a clinical IC has several disadvantages (see Figure 5). First, to be fair, there are many excellent employers who treat their dedicated employees very well: providing long-term employment, excellent benefits, flexible workhours, team spirit, training, and career growth. If you are working in this type of situation, do not leave the nest without lots of planning and good reasons—the grass is not always greener in the next situation.

Figure 5: Disadvantages of Being an Independent Contractor

You are not a “company man or woman”—you may not participate in company successes. You are the outsider.
No bonuses, annual compensation increases, health benefits, profit sharing, etc.
Once a contract ends, there is no guarantee of continued employment—you will have to find a new contract.
If working for start-up company, there are risks of company funding issues, bankruptcy, lack of payment.
Late or delayed payment is common.

Some individuals thrive in the IC marketplace while others fail financially or emotionally. You might not want to be a small business owner with record-keeping responsibilities or the occasional 50- or 60-hour week, mentioned earlier, that comes without overtime or a thank you. A contractor may experience significant gaps in employment and periods when income is insufficient. A contractor is likely to find both good companies and bad ones.

Finally, even if you are working as a clinical IC for a company with a great reputation, it is likely that you will still be considered an outsider and not part of the core clinical research team. You will likely be excluded from training opportunities outside the immediate scope of work related to your assigned project. You might never know the results of a study that consumed your time for months or the outcome of a registration submission. The emotional aspects of employment are often very important.

Conclusions

There are significant advantages and disadvantages to being a clinical IC. Individuals are encouraged to consider each of the factors presented in this article, speak to experienced contractors about their careers, and plan carefully. Improved long-term compensation, flexible schedules, and strengthened self-esteem are among the many benefits that might make this a good career choice for you.

References

Lim K, Miller A, Risch M, Wiking E. 2019. Independent contractors in the U.S.: new trends from 15 years of administrative tax data. U.S. Department of the Treasury. https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwjer_6h_d3yAhXxKVkFHQhgBlsQFnoECAMQAQ&url=https%3A%2F%2Fwww.irs.gov%2Fpub%2Firs-soi%2F19rpindcontractorinus.pdf&usg=AOvVaw3JVi-jVzRUg5X_GXo1nkQT
Katz LF, Krueger AB. The rise and nature of alternate work arrangements in the United States, 1995–2015. https://scholar.harvard.edu/lkatz/publications/rise-and-nature-alternative-work-arrangements-united-states-1995-2015
Shultz AE. 2002. The IRS vs. Independent Contractors. https://www.pharmavoice.com/article/2002-09-the-irs-vs-independent-contractors
Gautam A, Pan X. 2016. The changing model of big pharma: impact of key trends. Drug Discovery Today 21(3):379–84.
Tesar N. 2017. The clinical research BOSS: built on self success. Clinical Researcher. https://acrpnet.org/2017/12/12/clinical-research-boss-built-self-success/
Roberts A. 2013. The pros and cons of being an independent consultant. CRA Sources. https://clinical-cra.com/pros-cons-independent-consultant
Noguchi Y. 2018. Freelanced: the rise of the contract workforce. National Public Radio. https://www.npr.org/2018/01/22/578825135/rise-of-the-contract-workers-work-is-different-now
Methia J. 2020. COVID-19 creates urgent need for remote monitoring in clinical trials. Clinical Researcher 34(5). https://acrpnet.org/2020/05/12/covid-19-creates-urgent-need-for-remote-monitoring-in-clinical-trials/

Jerry M. Stein, PhD, ACRP-CP, ACRP-MDP, FACRP, is President and Owner of Summer Creek Consulting, LLC in Fort Worth, Texas, an ACRP Fellow, and a member of the ACRP Content Advisory Committee.