How to become a clinical research Professional Step By Step

How to become a clinical research Professional Step By Step

Contents

Professional in Clinical Research Defined

A clinical research professional’s (CRP) practice is guided by one or more principles of Good Clinical Practice (GCP).

CRPs may have training in nursing, pharmacy, medical technology, business administration, health record management, statistics, science, education, or other disciplines.

CRPs are employed in a variety of settings, including private practice, cooperative research groups, public and private academic institutions, pharmaceutical, device, and biotechnology companies, Clinical Research Organizations (CROs), Site Management Organizations (SMOs), independent research and development organizations, and other organizations involved in the management of clinical trials.

This definition EXCLUDES experts working under Good Laboratory Practice (GLP) and/or Good Manufacturing Practice (GMP) norms.

A CRP may serve as a:

• clinical investigator

• sub-investigator

• clinical researcher

• research nurse

• pharmacist

• data collection

• analysis or monitoring

• case management of protocol participants

• recruitment and enrollment of human subjects

• protection of subjects and subjects’ rights

• development of informed consent documents

• preparation of adverse event experience reports

• construction or monitoring of case report forms

• maintenance of drug accountability records

• development of grants and budgets

• preparation of reports

• educating the public

How can We become a Certified professional in Clinical Research?

Investigate the requirements for becoming a credentialed clinical research professional. Determine if this is the best career based on job responsibilities, education, certification, and compensation.

What Is a Certified Professional in Clinical Research?

There are various types of professions in clinical research. As a clinical laboratory technologist, you would collect samples and conduct tests on patient samples that medical researchers may utilize to gain a better understanding of the causes and progression of the disease. Certification is only mandatory in a few areas, but even in states that are optional, it can increase work prospects.

The position of clinical research coordinator is an alternative option. These individuals, who are often trained medical scientists, organize, coordinate, and oversee clinical trials and other translational research projects. They ensure that all research employees adhere to trial protocols and safety measures. They may also document the progress of the research and assist with data analysis as it is gathered.

The following chart provides an overview of the entry requirements for the various levels of this profession.

Where Could I Find Employment for Clinical Research Professional?

According to the U.S. Bureau of Labor Statistics (BLS), most research professionals divide their time between offices and laboratories. Employers in the public and commercial sectors include universities, federal agencies, research and development divisions of technology corporations, and pharmaceutical manufacturers. Your position may require long hours to fulfill deadlines and may necessitate working with potentially dangerous research materials.

What Training and Education Do I Need to Become a Clinical Research Professional?

You have several undergraduate and graduate study choices if you’re interested in working as a clinical research coordinator, often known as a medical scientist. Certificate programs in clinical research are often geared toward those with a bachelor’s degree in a scientific subject (or an equivalent employment background) who seek to expand their knowledge of research techniques. Typically, these programs take approximately one year to complete.

Undergraduate degree programs (both associate’s and bachelor’s degrees) in clinical research are also available and are aimed at individuals who aspire to work in labs and research-based medical and scientific environments. Biology, mathematics, statistics, data administration, and diagnostics are typically covered in certificate and degree programs that may qualify you to become a laboratory research associate or project manager. Alternately, a bachelor’s degree in mathematics or physical science may provide you with the necessary skills and expertise to become a clinical research specialist combined with relevant work experience.

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How do I obtain certification to become Clinical Research Professional ?

The Society of Research Associates offers the certification of Certified Clinical Research Professional (CCRP) (SOCRA). To obtain this certification, you must meet particular school and work requirements, pass a test, and be a member of the organization.

Additionally, the Association of Clinical Research Professionals (ACRP) offers certification exams for credentials including Clinical Research Associate, Clinical Research Coordinator, and Physician Investigator. These tests are administered twice a year, in March and September, and evaluate your knowledge and problem-solving skills. According to the ACRP, you must meet both academic and professional experience requirements to qualify for certification.

What are some comparable alternative occupations for Clinical Researcher?

If you are seeking research-related employment outside the medical field, you should consider becoming a forensic science technician. Unlike clinical laboratory technicians, who test on research subject samples, these specialists conduct experiments on chemical and biological material from crime scenes to aid in criminal investigations. Typically, a bachelor’s degree is necessary for this position. You could also elect to become a health services manager if you’re interested in a different type of management role within the medical industry. Health services managers organize the operations of medical institutions and hospital units as opposed to directing research projects. You would need a bachelor’s degree or above to qualify for this position.

How To Acquire Experience as a Clinical Research Associate (CRA)

Do you wish to enter the field of clinical research? Want a Clinical Research Associate (CRA) position in ANY organization?

You’ve arrived at the correct location.

There are numerous CRA positions available. However, most businesses have one big issue with entry-level candidates. Employers want candidates with relevant CRA experience. Because you lack two years of CRA experience, your résumé never reaches the recruiting manager’s desk.

How can you obtain CRA experience if you are not taught how to become a CRA in college?

• You have completed four years of college and hold a degree in engineering, science, or management.

• You’ve worked for years as a foreign doctor or perhaps had your private practice as a physician

• You’ve earned a certification in clinical trial management

You undoubtedly possess the necessary qualifications for a position with the IRS. However, you are finding it nearly impossible to gain entry.

And let’s be honest. The majority of individuals in clinical research learn how to be CRAs on the job. They are hired and trained in a mysterious manner to become CRA.

In this article, I will provide everything I know that will assist you in creating a resume for clinical research.

My ultimate objective is for you to obtain a paid CRA position in any organization of your choosing.

So let’s get started

Hospital or Clinic Volunteer

This is my preferred method for gaining CRA experience. In addition, this method is precisely how I received my first break in the industry.

The majority of large hospitals and clinics have formal volunteer programs. The volunteer program is primarily designed for retirees who wish to give back to the community. But that does not preclude qualification.

You can volunteer at a local hospital or clinic in one of two ways. I will discuss each one in detail.

Traditional Volunteer

This form of a volunteer position involves washing hospital beds and replacing the bedding once a patient has left.

Alternatively, you may be entrusted with transporting patients from the emergency room to the radiology department for a CT scan or X-Ray.

Or you may be packing envelopes with notes addressed to hospital donors.

There is no required research. However, these internships are also open to individuals with little to no experience in the medical sector.

These volunteer positions are highly accessible. To indicate your interest and availability to serve as a volunteer, you just need complete the volunteer application form. Make sure to accurately fill out the forms.

You’ll need to devote at least four to six hours per week and be willing to help the community and patients. It has nothing to do with you or your desire to gain CRA experience. The focus is on the patients.

Your application for volunteer work will be accepted within a few days. You will then be required to undergo simple medical examinations to establish that you are a healthy human being who poses no harm to the patients.

Once your test results are received, and you pass, you will receive a volunteer badge and officially become a volunteer.

It is that easy.

You may now wonder, “How would volunteering at a hospital help me become a CRA?”

My brief answer: Patients are the foundation of any clinical research position.

Working closely with patients, physicians, and nurses allows you to absorb clinical knowledge that you would not otherwise be able to.

You are also developing the important ability to collaborate with physicians and nurses. The same persons function as site investigators and research coordinators for clinical trials.

After three to four months as a typical volunteer, you will have valuable clinical experience that you can include in your résumé.

You want the recruiter and hiring managers to understand how your volunteer activity affected clinical practice, what you witnessed or learned, and your impact on patients’ lives.

Clinical Research Participant

I think this is a unique and uncommon volunteer opportunity.

Numerous practicing physicians have a strong interest in conducting research. However, they do not publish research papers or give presentations at conferences.

Why Become a Clinical Research Participant?

Because patient care is a full-time occupation, in the United States, a family practice physician must see at least 18 to 22 patients per 8-hour shift. It implies that the job will leave minimal to no time for research.

The clinicians do not have sufficient time to create a protocol, submit an IRB application, review medical records or charts, or analyze clinical data.

Here, though, you come to the rescue. Follow these five basic steps to gain expertise in clinical research.

Determine which treatment areas are of interest in

Step 1: If you are uncertain, I suggest cardiology, cancer, or diabetes.

Step 2: Identify physicians who practice in those disciplines. You can locate these physicians by visiting the website of the local hospital.

Step 3: After finding possible doctors with whom you like to collaborate, write each of them a tailored email stating your desire to participate in research as a volunteer.

Step 4: After a few email exchanges and likely an in-person interview with the doctor, you will land your ideal volunteer position in clinical research.

I obtained one article and one presentation on newborn care by following this procedure.

After completing your research paper or presentation, you may add it to your CV and brag about it to recruiters and hiring managers.

Intern for a Fortune 500 firm

The majority of us recognize the significance of an internship. It is a terrific method to gain valuable clinical experience while maybe earning extra money.

A healthcare internship with a Fortune 500 company such as Pfizer, Abbott, Merck, Apple, or even Google (yes, Apple and Google have healthcare goods) can be enriching.

These are also the most desirable internships. However, that does not imply you cannot enter.

Advantages and disadvantages of internships with Fortune 500 firms

• Outstanding clinical training opportunities You will study and implement standard operating procedures, applying Good Clinical Practice to real-world studies, cross-functional teamwork, and more.

• It is likely that you will be paid for your time as an intern.

• A organized application procedure demands planning. Generally, you must submit your application 9-12 months prior to the desired internship start date.

• The majority of participants in the internship program are full-time or part-time students.

• Extremely competitive (but hey, competition can make things better)

Employed by a Healthcare Startup

This technique is a continuation of obtaining internship positions at Fortune 500 healthcare businesses.

When most people consider employment opportunities or internships, international corporations immediately spring to mind. However, only the leading corporations are included on the Fortune 500 list.

Dozens of more healthcare-related businesses do not reach the Fortune 500 list.

According to a fast search on Angel, there are at least 18,956 healthcare businesses. Co. This list does not even include established corporations that did not make the Fortune 500.

A position at a healthcare startup that provides medical products or services is a beautiful opportunity to expand one’s knowledge of the healthcare industry and make a more significant social impact.

Here are the reasons I believe a healthcare startup will adore you:

• The majority of startups are resource-constrained. Resources may include money, time, or individuals. Therefore, if a startup can obtain an exceptional talent like you, they can conserve one or more of these resources.

• The majority of startups aim to expand and convey their message. If you can contribute to the firm’s goals and assist them in moving one step closer to the finish line, they will have no choice but to fall in love with your enthusiasm and dedication to their company.

Working for a healthcare startup: pros and drawbacks

Pros:

• In a healthcare startup, you can wear a variety of hats. You will alternate between working on a new clinical experiment and packaging boxes to convey medical supplies to a clinical trial site. This experience is precious to businesses hiring for CRA roles.

• You will have the opportunity to work on significant problems. If you can seize these possibilities and demonstrate execution and outcomes, you can advance your clinical research career.

• In contrast to Fortune 500 healthcare firms, startups are less well-known among job searchers. This makes obtaining an internship, full-time, or part-time work extremely simple.

• Your job goals may not be as regimented as those of a Fortune 500 corporation. You will likely be on your own and need to sort things out by asking people questions or searching government websites such as FDA.gov for clinical information.

• There will be no defined application procedure for internships. To get your foot in the door, you will need to contact and call the CEO, or head of clinical or R&D. Your position may not be confined to clinical research. • You may or may not be compensated for doing non-clinical duties or achieving non-clinical objectives. Depending on the terms, you can negotiate

Resources: Employed by Healthcare Startups

biospace.com is my favorite website for researching healthcare companies. The list is exhaustive of biotechnology, pharmaceutical, and medical device firms. Similarly, healthcare companies can be researched on angel. co.

Simply begin perusing the firm websites one by one, identify the CEO or vice president of clinical, and initiate contact with them to inquire about possible internship opportunities.

I am aware that it is a tiresome process.

In addition, there is a fear component associated with sending unsolicited emails to strangers. This is precisely why so few people engage in this activity.

But if you want to become an IRS agent, this is your greatest opportunity.

Employed by a clinical research site or network

Similar to volunteering at a hospital or clinic, you can apply to work at a clinical research site or network of clinical research sites.

Let’s begin by establishing some definitions.

A clinical trial is done at a clinical research site.

It is typically where the site investigator and research coordinators meet with potential and present clinical trial patients, hold regulatory binders, manage patient medical information, and conduct other monitoring operations.

A research facility may be a single office or a component of a more extensive hospital system.

Many modern clinical research professionals, including clinical research associates (CRAs), began their careers as clinical research coordinators (CRCs) at trial sites.

Hospitals and clinics seek CRCs to enroll patients in clinical trials, analyze medical records, and perform data input for clinical databases. In many ways, this event is the foundation of many CRAs in the industry.

Notably, although many CRCs are Registered Nurses (RN), RN certification is not required to become a CRC.

In contrast, a clinical research site network is a network of locations, as its name implies.

To decrease fixed costs like marketing and business development, provide a consistent experience to trial sponsors and CROs, and/or fulfill the highest clinical research requirements, sites will build or join sponsored networks.

Advantages and disadvantages of working at clinical research sites or site networks

• One of the most effective techniques to comprehend the inner workings of a clinical research site

• Possibility of collaborating with numerous sponsors, CROs, and patients. Not only will you get significant experience, but you’ll also expand your network, which can ultimately help you land a full-time CRA position. • Highly desirable experience for firms seeking CRA or CRA assistant candidates.

• Due to the academic and research-driven focus, internship stipends or salaries may be lower than industry jobs (sponsor/CRO)

• If you are an intern, you may not be permitted to work directly with patients due to privacy concerns or site policy. Instead, you will be assigned menial tasks such as completing regulatory documents or filling out subject case report forms, which you should execute with pride.

Resources: How do you locate a place for clinical research?

Finding locations for clinical research might be challenging.

A Google search or word of mouth will be required for independent clinical research sites.

“clinical research site + [your city/state/country]” search results. If the site has a web presence, it is possible that you can locate it.

Large hospitals, especially medical schools, conduct clinical trials and maintain a clinical research division.

You essentially contact the director of their clinical research or human resources (HR) department and inquire about job openings in their department.

Resources: How do you locate a network of clinical research sites?

There are several site networks. However, the sites that engage in these networks are not always accessible to the public.

Why?

Because some site networks charge sites an annual flat price to be a part of their site research network or because the site network costs sponsor to gain access to their sites. Someone must pay for this information, either the websites themselves or their sponsors.

Clinical Research Network provides a public directory of network sites. You can contact any or all of these sites and inquire about potential research career opportunities.

Additionally, Center Watch provides a list of locations organized by geographic location.

Research Match is an NIH-funded project that brings patients and researchers together. There are some notable institutions present. You can contact any of these sites to determine if they are hiring or seeking volunteer assistance.

Platinum Research is an additional website that provides a directory of site research networks. Click on “business websites” for information about local research facilities.

Employed by a Site Management Company (SMO)

Working for an SMO is a wonderful opportunity to gain CRA experience, similar to other employment opportunities we’ve explored.

An SMO supervises trial management activities on a research site daily. Simply said, the SMO’s responsibility is to fill in the holes at a site.

A facility may, for instance, lack a dedicated research coordinator. At this point, the SMO comes into play. Other locations may have an SMO designated by the clinical trial sponsor or clinical research organization (CRO).

Working at an SMO is comparable to working at the site in several ways. In general, 12 to 24 months of SMO experience will suffice to meet the “two-year” CRA experience requirement of most sponsors or CROs.

Pros and drawbacks of working for an NGO

• Opportunities are less well-known. Thus your chances of being hired are fairly strong.

• Possibility to comprehend the difficulties encountered by clinical research locations. This experience is valuable for anyone considering a career as a CRA.

• SMOs are more prevalent in Asian nations such as China, Japan, India, and Taiwan. This may be one of the most effective strategies for obtaining foreign clinical research experience.

Cons:

• SMOs based in the United States are not as expected, and it can be challenging to find one closer to where you live;

• Many SMOs are regional because they service sites in their region;

Employment with a Clinical Research Organization (CRO)

A CRO provides sponsors with clinical research services. Additionally referred to as Contract Research Organizations

CROs are currently more popular than ever. Many Sponsor companies, whether large or small, lack the clinical knowledge required to conduct a study. This is when the CRO comes into play.

A CRO offers the Sponsor the clinical resources required to execute a clinical strategy, namely the necessary personnel. If the Sponsor abandons a medical product or discontinues a clinical trial, engaging a CRO prevents them from being trapped with permanent staff.

The size and specialty of CROs might vary. For example, specialty CROs only serve specific therapies, areas, or types of medical items, such as a medical device research CRO.

Positives and negatives of working for a CRO

Possibilities to work on numerous therapeutic areas, medicinal goods, and Sponsor firms. Possibility to engage persons with little or no clinical research experience.

• Many CROs provide on-the-job training programs to aid in your professional growth.

• The service-oriented ethos of CROs might result in a stressful work atmosphere when dealing with demanding Sponsors

• Sponsors generally examine and approve CRO employee assignments.

• Pay for entry-level occupations is likely to be modest. However, if you care about gaining CRA experience, pay should not be a concern initially. Build CRA-relevant experience and then pursue another job within or outside the CRO

• Job descriptions may state a two-year minimum experience requirement, but I advise you to apply to these junior-level positions such as CRA assistant or clinical site coordinator/associate

• First Clinical Supplier Directory, which covers various organizations that provide contract clinical research services, is an additional resource for locating CROs.

Government (Regulatory) Agency Internship

The government plays a vital role in clinical research. They evaluate and certify medicinal products. Their top priority is patient safety.

Such institutions include the U.S. Food and Drug Administration, European Union competent agencies such as Germany’s BfArM, and the Chinese FDA.

Government laws and regulations are the foundation for any corporation seeking commercial certification for a medical product. The laws and regulations also apply to service-based businesses like CROs and SMOs, as well as clinical trial sites performing research.

Every clinical organization is required to comply with the law. This is what makes working for the government interesting. When it comes to clinical research, you can acquire knowledge that genuinely matters. You can then utilize these insights as you progress in clinical research.

Pros and drawbacks of a government (regulatory) agency internship

Pros:

• You will learn a great deal about health care rules, patient safety, and government agencies decisions. This is a tremendously valuable experience to have early in your career. • CRA hiring managers and recruiters highly value this experience.

• Numerous possibilities will be unpaid or may offer a little honorarium. Volunteering with a government organization is a fantastic method to boost your CV if your primary purpose is to acquire important research experience.

• Some organizations may require you to be a citizen of the nation where you wish to work.

Resources: Governmental (Regulatory) Organizations

Check the website of your country, state, county, or municipality to see which government department or division is responsible for overseeing healthcare programs such as clinical trials.

The Food and Drug Administration provides a program for unpaid student volunteers. This program is open to non-US nationals, including permanent residents and visa holders, to my joyful surprise.

You may also volunteer at FDA field offices, eliminating the requirement to move to Maryland. But if you can work at the FDA’s headquarters, you will have access to more personnel and resources.

Other significant governments or government-funded institutions include:

• The National Institutes of Health (NIH) offers a program for college students and recent grads.

• The Centers for Disease Control and Prevention provides a fantastic program for college students and recent grads.

• The U.S. National Library of Medicine offers job options.

• The World Health Organization (WHO), a United Nations body, also offers an internship program.

Employed by an organization that focuses on healthcare initiatives. Nonprofit organizations exist to fill voids that the corporate and public sectors are unable or unwilling to fill. Nonprofit organizations are mission-driven.

There are dozens of nonprofit organizations devoted to healthcare programs and medical research in the United States. Association of Clinical Research Professionals and the American Heart Association are examples of such nonprofit organizations.

Many individuals seeking CRA experience are primarily interested in CROs and Sponsor firms. However, numerous lesser-known NGOs seek individuals like you to work in the healthcare industry.

Your initial work with these nonprofits will likely not be with the CRA, but you will receive a valuable experience that will enable you to transfer to a career with the CRA in the future.

Positives and negatives of working for a nonprofit

•Nonprofitt organizations typically seek out motivated individuals to support their purpose.

• In the majority of firms, clinical research experience is not required. • Outstanding opportunity to engage in meaningful work not centered on the financial bottom line. Money motivates for-profit enterprises, and the labor may not be as satisfying.

• Anonprofitt organization might not be able to afford exorbitant compensation. You may receive a stipend or sufficient funds to existing.

Resources: How do locate Nonprofitt Organizations with Healthcare Initiatives?

• First Clinical provides one of the most complete clinical research association listings directories. Most of these industrial associations are likely nonprofit organizations. Simply contact the Executive Directors of these groups and organizations to enquire about volunteer, full-time, and part-time possibilities.

• Guidestar is the most comprehensive directory of nonprofit organizations in the world. You can search for charitable organizations in the “Medical Research” or “Health” category and sort by “Gross Receipts.” If you approach groups with financing first, they will be more likely to offer you a paid position.

• Similar to Guidestar, Charity Navigator allows you to run an Advanced Search for NGOs in the Health Medical Research category. • The Department of Health and Human Services Health Finder provides a directory of charity organizations in the healthcare field.

Invest In Your Education

One of the most effective ways to get CRA experience is to engage in your education. You can enroll in a certification program through organizations like ACRP and SOCRA.

ACRP also offers paid and free online training and free GCP certification through NDAT CTN Training and clinical research courses through Coursera.

However, certificates and training are insufficient to qualify for a CRA position. You must “learn” through hands-on practice.

Consider volunteering or attending clinical research conferences offered by organizations such as ExL events, CBI events, ACRP, or SOCRA. These conferences allow you to network with people with similar interests, providing chances for you and everyone else in attendance.

Last but not least, I would be doing a disservice to this essay if I did not discuss the crucial soft skills you must learn to become a CRA. Soft skills include negotiation, active listening, not complaining, empathy, and self-awareness.

Conclusion

We have discussed nine alternative strategies to earn CRA experience. Choose 1-2 possibilities from this list, then pursue them with all your concentration and vigor.

1. Hospital or Clinic Volunteer

2. Intern with a Fortune 500 organization

3. Working for a healthcare startup

4. Employment at a clinical research site or network

5. Employed for a Site Management Company (SMO)

6. Employed by a Clinical Research Organization (CRO)

7. Intern at a Regulatory Agency

Work for an organization that focuses on healthcare initiatives.

Invest In Your Education

About Kalina Erdania

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