Medical Monitoring in Clinical Research - Non Clinical Physician Jobs
What Is medical monitor in Clinical Research?
A Full Overview and Guide to Becoming a Physician Medical Monitor
Considered a “Hidden Gem” for Non Clinical Physician Jobs
Clinical trials are the bedrock of medical progress, meticulously evaluating the efficacy and safety of novel drugs and treatments. Within this vital process, medical monitors (MMs) play an indispensable role. These physician-experts oversee critical aspects of the trial, guaranteeing both patient well-being and the scientific integrity of the research. For those interested in this role, consider our Medical Monitor Certification.
Distinct Expertise: Physician-Level Oversight Makes the Difference
While clinical research associates (CRAs) ensure protocol adherence and accurate adverse event (AE) reporting at trial sites, medical monitors bring a physician's perspective. They leverage their medical knowledge to:
Guide Protocol Development: Medical monitors advise on designing protocols that prioritize patient safety and align with current best practices as outlined by the National Institutes of Health (NIH) in their guidance document, "Clinical Trial Design Considerations for Safety" NIH Guidance. For those looking to further understand protocol development, consider our ICH-GCP course.
Evaluate Safety Concerns: Throughout the trial, they assess and address patient safety issues that may arise, referencing the Food and Drug Administration's (FDA) "Guidance for Investigators for Conduct of Human Clinical Trials" FDA Guidance for best practices.
Make Unblinding Decisions: In rare cases of severe AEs, medical monitors determine if unblinding is necessary for effective intervention, following the European Medicines Agency's (EMA) ICH Guideline E6(R2) on Good Clinical Practice EMA Guidance. Aspiring professionals can deepen their understanding with our Advanced Clinical Research Project Manager Certification.
Beyond Oversight: Fostering Effective Collaboration
Similar to CRAs, medical monitors act as liaisons between sponsors and trial sites. They review and ensure proper coding and reporting of AEs, guaranteeing data accuracy and adherence to regulatory guidelines set forth by organizations like the International Council for Harmonisation of Good Clinical Practice (ICH-GCP). For further training in these responsibilities, explore our Clinical Research Coordinator course and Pharmacovigilance Certification.
The Multifaceted Role of the Medical Monitor
The complexities of clinical research in 2024 demand a multifaceted role for medical monitors. Their responsibilities encompass:
Protocol Review and Design: Scrutinizing protocols to prioritize patient safety and ensure alignment with best practices. Consider our CRA course for detailed insights into this role.
Safety Oversight: Continuously monitoring patient well-being throughout the trial and addressing any safety concerns.
Data Analysis and Interpretation: Collaborating with the research team to analyze and interpret trial data effectively.
Regulatory Compliance: Ensuring the trial adheres to all relevant regulatory requirements.
Communication and Collaboration: Acting as a bridge between sponsors, investigators, and research teams, fostering clear communication and collaboration.
Specialist Services for Streamlined Trials
Contract research organizations (CROs) and sponsors often partner with specialist companies like C3i Solutions and GeorgeClinical to leverage their expertise in providing medical monitor services. For those aspiring to excel in assisting clinical trials, our Clinical Trials Assistant Training offers comprehensive insights.
Additionally, for those interested in reaching the pinnacle of research oversight, consider the Advanced Principal Investigator Physician Certification.
Essential Resources
National Institutes of Health (NIH): Role of Medical Monitors in Safety Oversight https://www.niaid.nih.gov/sites/default/files/medicalmonitor.pdf
Explore Our Clinical Research Training Programs:
Key Distinctions: Medical Monitor vs. Other Clinical Trial Roles
It's crucial to distinguish the medical monitor from other vital clinical trial personnel. Here's a quick breakdown:
Medical Monitor vs. Principal Investigator (PI): PIs lead trials at a specific site, while medical monitors offer broader oversight across multiple trials and sites.
Medical Monitor vs. Clinical Research Associate (CRA): CRAs focus on protocol adherence and data collection at a single site, whereas medical monitors provide physician-level expertise for broader trial aspects.
Understanding Medical Monitoring According to E6-GCP
The E6 Good Clinical Practice (GCP) guidelines define a medical monitor as a person responsible for supervising the clinical trial process. They ensure that protocols, standard operating procedures (SOPs), Good Manufacturing Practices (GMP), and regulatory requirements are all followed according to established standards as outlined in the European Medicines Agency's (EMA) ICH Guideline E6(R2) on Good Clinical Practice https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-clinical-practice
Alternative Terminologies for Medical Monitor
It's important to note that medical monitor is not the only term used for this role. Here are some alternatives:
Clinical research associate (CRA)
Site manager
Senior CRA
Clinical trial assistant (CTA)
However, clinical research associate (CRA) is the most frequently used alternative. Be aware that while there may be some overlap in responsibilities, CRAs
Difference between a Medical Monitor and Principal Investigator
What is a medical monitor in clinical research
Salary of a medical monitor
Salary of medical monitor varies due to different factors including education, certifications, additional skills, number of experience years in profession.
The average salary of a medical monitor is 155,000$ and salary usually ranges from 87,000$- 398,000 (Ziprecruiter).
The national average for CRA is $65-119k which is different than medical monitors working in the pharmaceutical companies.
There are so many opportunities in the clinical research industry. At the site level, some are study coordinator, principal investigator, sub investigator, research assistant. At the CRO level there are CRA's, CTA's, CMA's, medical monitors, project managers. At a Sponsor level there are dozens more. What is good about many of these, is one's ability to "level up" over time into more desirable and higher paying positions.
Skills and qualifications required to be a medical monitor:
Medical degree with strong leadership skills
Direct experience in the pharmaceutical industry (i.e. Clinical Research Associate; preferred; although with CCRPS Medical Monitor Certification you are qualified to work as both a CRA and MM)
The preferred countries for the experience are US and EU
Knowledge of both local and Global regulatory requirements as well as the
knowledge of local and Global GCP
Skillful in converting input into regulatory documentation.
Strong communication skills to deal with stakeholders either internal or external.
Strong writing and presentation skills.
Skillful to deal with audience especially medical and scientific community.
Relevant work experience in medical monitoring and/or pharmacovigilance
and/or drug safety experience in a CRO, pharmaceutical, or clinical trial environment required.
Must have appropriate understanding about the International conference on Harmonization (ICH), GCP guidelines.
Must have appropriate knowledge of research, clinical trials and clinical terminologies.
Having strong decision-making power to deal with the trials.
Proficiency in English (written and verbal) required.
Capable of building and maintaining the trust of clients.
You can showcase and gain the knowledge you need to work as a MM with CCRPS’s Medical Monitor certification which trains you to a Senior Monitor’s level of knowledge to allow for easy promotion in the field. You do need experience before getting promoted so we suggest getting an internship while studying for the course prior to applying for Medical Monitor or CRA jobs!
Individuals who should try to be a medical monitor include:
Typically this is a fully qualified physician (MD, MBBS, IMG, FMG)
Sometimes residency in the work-specific department or in internal medicine is helpful (whether international or US-completed)
In the US it is also permitted to also use a PharmD (pharmacist) as a medical monitor
Role and responsibilities of a Medical monitor:
At the clinical trials site, role of the monitor depends upon the experience of the monitor as well as the phase of the ongoing trial. A monitor is a competent person performing differant responsibilities and activities at different sites in accordance with the phases of trials. Some of these responsibilities are:
While discussing and presenting the facts and initiating a trial with investigator a monitor must become a mentor and counsellor.
Responsible for developing devices and conducting research on drugs in improving the quality of life of patients.
Providing monitoring reports, the guidance about further actions, lacking in the study, elaborating findings to improve compliance.
Dealing with the recruitment of the research patients and their retention or exclusion for obtaining quality findings.
Situation handling is the main responsibility of the monitor to safely resolve the issue by troubleshooting the problem.
Planning of travelling costs and schedules are also maintained by the monitor.
A monitor works as a detector when it comes to decide a site for trial and visiting the
sites.
Effective communication and convincing ability while dealing with different levels of
the people is the major skill and responsibility of the medical monitor.
Developing regulatory and study related documents including, study design, writing the abstract of the protocol, concluding the protocols, approval of the study template of informed consent and preparation of the documents.
Conducting a successful study includes, attending the meetings and answering the questions of the management teams, data monitoring committee and other teams.
Data reviewing responsibilities includes, reviewing the patient data along with vital
signs and abnormalities, approving patient narratives and GCP guidelines.
Making the study team capable of resolving the issues, deciding inclusion and
exclusion criteria, studying closeout and inspection readiness.
How to become a certified medical monitor:
MD, MBBS, FMG, IMG are eligible to apply for the certification and for these non clinical physician jobs (learn more at nonclinicaldoctors.com). These health care professionals will be able to get adequate knowledge and experience to deal with the clinical trials. These professionals would have the ability to deal with the adverse events occurring during the trials. After medical monitor training and certifications; chances of their hiring by CRO’s (contract research organization) would increase. Unmatched MDs can pursue this as a phenomenal career path (see unmatchedMD.com).
CCRPS is here to provide one of the most-advanced courses related to medical monitor: https://app.ccrps.org/courses/medial-monitor-certification
7 Reasons Why You Should Start a Career in Clinical Research
begin a Career in Clinical Research
How you ever thought that there’s a perfect job out there for you, but you just haven’t found it yet? If you are motivated, informed, and interested in a science and medical career, you might have just found your answer. Many clinical research professionals say this is the golden ticket to a great career in the science field.
Why Clinical Research as a Career
The clinical research industry is a highly lucrative and expanding field. The global clinical trials market has been estimated at $46.8 billion in 2019.
As the push for new vaccines and therapeutics continues to get stronger, the field is expected to grow even more in value. Experts predict that the global market will hit $69.9 billion by 2027. The future in clinical research is bright, and it is one that you will want to be a part of.
Contrary to popular belief, working in clinical research doesn’t have to mean you have to stay in a lab. There are demands and opportunities for every skill set, if you know how to find them. Below, I have put together an in-depth guide on why you should get into clinical research.
Working in Clinical Research
You like a job that’s flexible
Don’t like working in a cubical? How about heading to the airport every morning instead? If you like a job that keeps you moving, then becoming a Clinical Research Associate (CRA) and working in clinical trials might be the right move for you. Learn more about becoming a CRA with this CRA Certification Course.
CRAs, contrary to what most people believe, don’t collect data or interact with patients. A CRA’s day-to-day job is to travel between different research sites and verify data transcription (i.e., data management). CRAs can also become part of the project management as a clinical trial manager of an entire trial.
They are also called “monitors” and a part of "regulatory affairs", because it is also their job and clinical experience to ensure that every site is following proper compliance and protocols.
There are two types of CRAs: home base or in-house. Home base CRAs work remotely. That means they work and travel from home. Most CRAs work for contract research organizations who are hired by sponsors to conduct their multi-site trials.
If you get tired of working home base, you can become an in-house CRA. In-house CRAs stay in one site and work together with a home base CRA to keep each other updated with what is happening at their site.
You like working with people
Have you ever been told that you are a people person with great communication skills? If talking to someone about how you can change their health for the better sounds like something you’d enjoy, you should definitely look into becoming a Clinical Research Coordinator (CRC). Explore our Clinical Research Coordinator Course to get started.
CRCs are the backbones to every project. They conduct patient visits, input source documents into the electronic data capture (EDC), and ensure that every trial is following compliance. They are also responsible for handling regulatory documents and updating the Principal Investigator (PI) with trial results.
CRCs conduct a variety of tasks, all of which impact the progress and development of the trial. Every successful clinical trials team needs is a good CRC. So, if you have strong interpersonal skills and know how to stay organized, you will be an indispensable part of the team.
You are detail-oriented and tech-savvy
Are you a self-proclaimed techie? Perhaps you’ve dabbled in coding, pick up computer programs easily, and maybe even have a background in IT. Technology is the future. If you think you have a knack for organizing data, you should look into becoming a Clinical Trial Assistant (CTA). Check out our Clinical Trials Assistant Training to learn more.
CTAs, also known as Clinical Research Assistants, manage the Trial Master File (TMF). They file, archive, and maintain trial documents and study files. They are also responsible for closing inquiries from the CRA, as well as providing administrative support to the research team. Every important step in clinical research, pre-clinical research, study startup, site management, needs a dependable CTA.
While most jobs in clinical research require some understanding of technology, it is especially important for the CTA to know what they are doing when it comes to managing trial documents and study files. In addition, it is equally important that the CTA is organized and knows how to pay attention to detail.
Working in Clinical Trials
Means you like a good salary...with room for promotion
Though there are many career paths within clinical research, most people begin their career as CTAs or CRCs in entry-level positions. Depending on your skill set and what kind of experiences you can bring to the table, either position will help you get your feet through the door.
According to salary.com, a CTA’s average salary in 2020 is $63,000. They generally earn between a range of $54,300 and $73,000, and are provided with benefits such as healthcare and social security.
If being more hands-on in the research process appeals to you, you might be a good fit for a CRC. Similarly, CRCs are making an average of $63,117 in 2020. Most make between a range of $54,210 and $72,902, plus employee benefits.
While numbers tend to fluctuate between cities and states, there’s no denying that these are great salaries for an entry position. Since according to one of the largest global job recruitment sites, Glassdoor, the average base salary in America is $40,000. Starting with an annual salary of $60,000 is considered uncommon and on the high end of the spectrum.
After one to two years of experience on the job, most companies provide CTAs and CRCs opportunities for professional development and promotion. Many become Clinical Research Associates, or CRAs. Indeed reports that the average salary of a CRA with one to two years of experience is $72,358. After building at least 6 years experience, a seasoned CRA should expect to earn $110,102 a year. If you would like to make more money, you can consider becoming an individual contractor CRAs. They can earn up to $300,000 in a year.
You are a science professional wanting to change careers and don’t want to go back to school
In clinical research, experience is often valued over degrees. Rather than what you didn’t study in college, hiring managers are more interested in what you have done in the past and how they can integrate you into their company.
This includes getting certified through clinical research courses, but more so what you learn from the courses you take. CCRPS offers the most in-depth CRA and CRC training so that there's tons to talk about during the interview and a working bank of knowledge during the first few months of the job. Explore more specialized certifications like ICH-GCP, Advanced Clinical Research Project Manager Certification, and Advanced Principal Investigator Physician Certification to further enhance your qualifications.
While graduate programs can help point you in the right direction, you don’t need a master’s degree to succeed in clinical research. In fact, certain positions don’t even require a bachelor’s or associate’s degree; they have certification in clinical research.
Applying to CRC and CTA positions are one of the most common segways into higher positions in clinical research. CRCs don’t need a bachelor’s or associate’s degree to get their foot in the door. While both CTA and CRA positions require a bachelor’s degree, they don’t have to be in the life sciences.
One of the best ways to gain experience and stand out from the crowd is to have on-site experience. If you need advice on how, Dan Sfera, the CEO of DSCS CRO Clinical Research Services, recommends getting started by interning or volunteering at clinics and research sites to build connections and experience.
Sometimes, the easiest way to get involved is to offer services like patient recruitment and social media management in exchange for opportunities to build your CV. By appealing to a site’s needs, this will help you get your foot in the door and build the connections and resume you need.
Another great way of adding experience to your resume is by training throughcertification courses. When employers see that you have taken the time and effort to understand how to be the best in their field, they are more far likely to hire you. At CCRPS.org, we offer seven courses and certification trainings to give you an advantage. Most of our students are hired within the first month of taking the course. We are accredited by the Accreditation Council For Clinical Research Education (ACCRE) and Joint Commission by the AMA, ANCC, and various other organizations to provide 17.5 CME credits through our CRA Certification and CRC Certification.
6. You are switching careers
Switching career fields can be nerve wracking. However, it is also an opportunity for you to be a unique candidate. Whether you come from a closely-related background, like medicine or nursing, or something completely different, there are ways you can advocate for yourself in front of employers.
If you already have a background in medicine (nonclinical doctor, unmatched MD), your knowledge of healthcare and your passion for patient health will make for a smooth translation into clinical research. In addition, your RN or MD degrees will help you gain a competitive edge and allow you to climb higher positions, such as the PI, who is the primary researcher of an operation.
On the other hand, if you come from a less relevant field but feel passionate, you can still leverage yourself to be exactly what the clinical research field needs. For example, if you are a teacher, your communication and interpersonal skills will be your keys to success. If you are a lawyer, your ability to draft and read papers will far surpass the average candidate.
If you studied mathematics, you are a skilled problem solver. If you are a translator, your language skills are valuable and will help you get into roles that require it. In short, whatever skills helped you succeed in your previous positions, you can bring it with you to clinical research.
7. You want to make a difference in disease outcomes and patient care
There are two types of people in the world: ones who accept the world as it is, and ones who strive to change it. In the last 50 years, science and medicine have gone through a series of drastic changes. However, anyone who works behind the scenes will tell you that medical breakthroughs are not miracles. Clinical research is the culmination of human effort and intelligence.
The fruits and labor of the ever-expanding industry are proof that if enough people care about the world, then they can change it. While there are many good reasons to work in clinical research, if you want the privilege to enrich the lives of others, there is a place for you in this field.
If you want to take a sneak peak at employers and opportunities near you, jobs sites like Indeed are a great resource.
Here are links for aspiring CRAs, for CRCs, and for CTAs. (Note: CTAs are often referred to Clinical Research Assistants, not to be confused for Clinical Research Associates)