Zhi Zeng Zhi Zeng

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

  1. 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.

  1. 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.

  1. 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

  1. 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.

  1. 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)

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Clinical Research Associate Training UK

Clinical research is a field with a lot of career potential all over the world. Clinical research associates, or CRAs, are one of the most sought-after positions in the field. CRAs monitor labs and research processes. It is a position that offers financial security and many traveling opportunities for work. In this article, we have put together a short work guide on becoming a CRA in the UK. According to SalaryExplorer, the 2020 average salary of a CRA in the UK is 82,700 GBP. Depending on your experience and location, you can expect to earn anything from 38,000 GBP to 131,000 GBP.

United Kingdom Clinical Research Career Guide

Clinical research is a field with a lot of career potential all over the world. Clinical research associates, or CRAs, are one of the most sought-after positions in the field. CRAs monitor labs and research processes. It is a position that offers financial security and many traveling opportunities for work. In this article, we have put together a short work guide on becoming a CRA in the UK. For more detailed training, check out our CRA training program.

Salary:

According to SalaryExplorer, the 2020 average salary of a CRA in the UK is 82,700 GBP. Depending on your experience and location, you can expect to earn anything from 38,000 GBP to 131,000 GBP.

On average, CRAs with less than 2 years of experience earn an average salary of 43,200 GBP. However, a CRA’s salary increase exponentially after 2-5 years of experience, increasing by 34% (57,700 GBP per year). They increase another 48% after obtaining 5-10 years of experience (85,200 GBP per year). 

Requirements to Work:

The minimum education requirement to work as a CRA in the UK is a bachelor’s degree. However, investing in a master’s degree will increase your qualifications and earning power. SalaryExplorer has shown that CRAs with a master’s degree have a 93% higher average salary than CRAs with just a bachelor’s degree. Explore our ICH-GCP course to enhance your qualifications.

Although clinical research is a global field, job requirements and salaries can differ from place to place. After reading this guide, we hope that you have a better understanding of what it is like to work in the UK. If you want to learn more about clinical research and becoming a CRA, please check out our CRA training program and our articles below to learn more about the international job scene.

The aim of this course is to help healthcare professionals and other non-medical/dental healthcare professionals and those that are already working in the clinical research industry who want to develop and acquire skills and knowledge. This course will help you to develop the knowledge of the theoretical aspects of clinical research and the skills that are relevant in research methodology that are applicable to researches in the contemporary clinical practice settings.

The benefits of taking this clinical research online course are:

It helps you to develop an in-depth knowledge and an understanding of the nature, purpose, different methods, and application of research that are relevant to clinical practice as an individual or in an organization.

  • It develops and builds your capacity for research and fosters evidence-based practice. This is done by equipping you with the knowledge and skills that are needed in the critical appraisal, application, designing, and undertaking of high-quality research within different range of clinical settings.

  • It provides you with an excellent research training with outstanding resources and expertise in the field, in a supportive environment that allows you to thrive in your pursuit for clinical research knowledge.

  • It will enhance your opportunity to pursue a career in clinical research and an opportunity to further your clinical research training with advanced knowledge of clinical research and practice. Consider our Advanced Clinical Research Project Manager Certification and Advanced Principal Investigator Physician Certification.

  • It will develop your critical thinking and reflection skills, help you to be more effective in communication, improve your team and multidisciplinary work, your use of health informatics, and help you to be more systematic in decision-making and problem-solving.

  • You will have the opportunity to learn from and interact with renowned professionals from the clinical research field, and other health-related fields, and other industry experts who will serve as lecturers for this course.

  • This mode of this clinical research online program allows you to be more flexible with how you learn. The proprietor ccrps.org makes use of digital technology such as individual and group web based audiovisual tutorials and discussion boards in order to ensure the supervision of their students and constant communication. We are here to ensure that students meet the field standards and that the students are able to learn.

Take courses from CCRPS and learn more on how to become a clinical research professional.

Discover more from Clinical Research Training | Certified Clinical Research Professionals Course

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Clinical Research Project Manager

Clinical Research Project Manager - A Full Guide To Becoming a Clinical Trial Project Manager

As of mid-April 2022, top recruitment platform ‘indeed.com’ lists 6,026 openings for Clinical Research Project Managers across the United States[1]. According to ‘payscale.com’, remuneration for this profile ranges from $84,168 for early-career to $120,501 for experienced Clinical Research Project Managers, with a mid-career median of $107,649[2].

A Clinical Research Project Manager (henceforth CRPM) is also known as a Clinical Research Manager or a Clinical Trial Manager. The role of a CRPM is to provide leadership during the clinical trial of new drugs, with the overarching goal of ensuring that the clinical trials process is completed within the stipulated time-frame and allocated budget, while maintaining the highest standards of research quality and scientific integrity.

An overview of the CRPM profile

A Clinical Research Project Manager is the liaison between the study sponsor and the clinical research team. Thus, the CRPM must balance the expectations of the funding organization in a clinical research study (pharmaceutical company, governmental agency, university research division or other entity) with the needs of the team, including Principal Investigators (PIs) and co-PIs, Clinical Research Coordinators (CRCs), Clinical Research Associates (CRAs), and Clinical Trial Assistants (CTAs) and other site staff. 

The CRPM plays a leading role in planning, implementation and ongoing monitoring of live clinical trials. In the process, a CRPM also mentors junior team members, including CRAs and CTAs.

Evidently, a career as a CRPM is rewarding, but also demanding. So, what does it take to qualify and be recruited as a Clinical Research Project Manager?

The road-map to becoming a CRPM

Even if you’re new to the field of clinical research, you’ve probably guessed by now that becoming a Clinical Research Project Manager takes both qualifications and experience. A typical CRPM has a bachelor’s (or master’s) degree in life science, combined with four to five years’ experience in one or more clinical research roles such as CRC, senior CRA or QPPV (Qualified Professional in Pharmacovigilance).

Irrespective of where you are along this path, the remainder of this article charts a clinical research professional’s journey of growth in developing into a competent CRPM. For conceptual convenience, the process is discussed in two parts – Part 1 centers on the research and administrative skills needed for a CRPM, while Part 2 revolves around expertise in project management. The final sections address how the Advanced Clinical Research Project Manager Certification or ACRPMC facilitates the transition to a CRPM role.

The CRPM journey, Part 1: Research and administrative skills

By the time a clinical research professional is eligible to apply for a CRPM position, s/he has typically developed a range of competencies in the day-to-day running of clinical trials. In addition, a professional at this stage has usually acquired a good working knowledge of the planning and oversight required for a clinical research study.

In broad strokes, a CRPM candidate likely already has a knowledge base and skill sets in the following areas:

1. ICH-GCP guidelines, Title 21 of FDA CFR and IRB compliance

One of the first things every clinical research professional learns is the importance of adhering to the principles and policies of good clinical practice, as outlined in the ICH-GCP[3]—these guidelines set the framework for carrying out research in a manner that prioritizes the safety and welfare of human subjects and the quality and integrity of clinical data.

The ICH-GCP principles are mirrored by Title 21 within the US FDA’s Code of Federal Regulations (CFR)[4]. Clinical research across the US must conform to the requirements of Title 21. Part of Title 21 regulatory compliance requires nearly all clinical research studies to first be approved by an Institutional Review Board or IRB (also called an Ethics Committee). As clinical trials progress, any changes to the study trial protocol, consent procedures or data management system must likewise first be reviewed and approved by the IRB.

The CRPM has final responsibility for ensuring that all documentation necessary for clinical research regulatory compliance is maintained and updated as needed.

2. Clinical trial design concepts and parameters

A sound grasp of the clinical trials process is similarly a must for senior professionals in the team. Candidates for CRPM positions are thus expected to have a thorough understanding of key concepts and procedures relating to clinical research, including:

  • Phases 1 to 4 of clinical trials[5] 

  • Investigational products (IPs) including INDs and IDEs

  • Design concepts in clinical trials - control, randomization and blinding

  • Subject screening and selection, retention and study compliance

  • Trial data input, quality assurance, analyses and reporting

  • Adverse Event (AE) documentation and reporting

3. Pre-trial preparation

In some ways, the most crucial phase of a clinical trial is the preliminary or preparatory phase, during which all groundwork must be laid for the smooth and efficient conduct of the actual study. This phase must typically achieve the following objectives:

  1. Complete documentation for initiating clinical trials[6] – An IRB-approved clinical trial must have in place a host of documents covering important aspects of the study, including the investigator brochure (IB), trial master file (TMF), informed consent form, case report form (CRF), subject recruitment notice, laboratory protocol, study financial projections and so on.

  2. Identification and preparation of study site(s) – Most clinical research studies are run across multiple sites, which may be hospitals, clinics or other health-care facilities. Identifying suitable sites, establishing collaborative agreements with site administrators, as well as setting up the required infrastructure to carry out trials at each site is crucial in preparing for a clinical research study.

  3. Pre-trial publicity – The success of clinical trials depends on gathering large amounts of data from human subjects. Therefore, creating public awareness and interest right from the outset is critical to running clinical research studies effectively.

When setting up a study, the CRPM plays a central role in initiating and fulfilling each of the goals outlined above. Under the CRPM’s guidance, clinical research administrative staff including CRCs and CRAs work to put relevant documentation in place, prepare study sites and create public awareness about the study.

4. Active trial administration

The day-to-day running of an active clinical trial involves numerous administrative components, including:

  • hiring and training staff at clinical sites

  • tracking subject recruitment and retention

  • regulatory compliance in trial protocol, subject safety and data quality

  • Adverse Event (AE) documentation and reporting

  • oversight of trial drug storage and use

  • coordination among research teams across sites

  • tracking study finances

  • communication between study sponsors and clinical staff

  • electronic data capture (EDC) and management

  • timely renewal of necessary financial and regulatory approvals

These tasks are distributed among members of the investigative teams (PIs, co-PIs and other medical personnel) as well as administrative teams (CRAs, CRCs, QPPVs and other site staff). However, the CRPM is ultimately responsible for ensuring efficient administration that keeps the clinical trial on track.

5. Study termination procedures

Winding up a clinical trial similarly entails a number of administrative exercises. Here again, the CRPM must oversee execution, guiding team members in completing tasks on schedule and to the required standard:

  • site close-out (relieving staff, subject debriefing, equipment surrender)

  • final data consolidation and scrutiny

  • study completion documents for regulatory compliance

  • compilation of briefs and reports for regulatory authorities, study sponsors

The CRPM journey, Part 2: Expertise in project management[7]

Most aspirants to CRPM positions have usually been engaged in the clinical research process for at least a few years. Many have played administrative roles, working as CRCs, senior CRAs, QPPVs or site managers. In some cases, CRPM aspirants have clinical backgrounds, with expertise in drug research or medical monitoring.

Despite their hands-on experience with the clinical trials process, professionals wishing to transition to CRPM roles usually have limited exposure to the higher-level project management knowhow that is essential for an effective CRPM. This section provides a brief overview of the major project management domains relevant to clinical trial management:

1. Project and operations planning

A clinical trial is a major operation, involving a range of geographical and health-care settings, multi-disciplinary teams, as well as a complex array of regulatory and logistical requirements. Planning the stages, milestones and operations of a clinical trial is integral to assuring its success. Therefore, project and operations planning are the top priorities of a CRPM.

Some of the key elements involved in planning a clinical trial include:

  • Compiling a comprehensive study protocol describing the rationale, aims, design and methodology, data analysis plans, and trial procedure (/protocol)

  • Setting project goals, deliverables and milestones

  • Outlining a project personnel schematic that delineates team and sub-team structure and defines individual team member roles

  • Generating a responsibility blueprint with a clear break-up of tasks, targets and time-lines for each project goal and each team member

  •  Creating a communication plan that outlines the method and schedule for relaying information, updates and requests between and within teams

2. Financial forecasting and tracking

One of the biggest challenges confronting a CRPM is keeping the trial within budget, while making sure that resources are optimally allocated to cover all necessary project-related expenses. Clinical trials often suffer from scope creep, that is, the inclusion of additional goals and deliverables to those originally outlined, resulting in the project overshooting budget and time-line.

It is therefore recommended practice for a CRPM to work with study sponsors and senior team members in compiling a budget management plan at the very outset of the project. Such a plan not only specifies financial outlay for each of the goals and deliverables of the clinical trial, it also provides for periodic budget revisions to account for factors such as expanded project scope, rising costs and supply-chain changes.

3. Human resource allocation and oversight

The section on project and operations planning highlighted the importance of creating a personnel schematic as well as a responsibility blueprint at the start of a clinical trial. Through this process, a CRPM is able to clearly define roles for various team members in meeting project goals and milestones, and their contributions to each project deliverable.

However, in order to ensure collaborative effort and a cordial work environment, it is essential for a CRPM to also formulate a transparent hiring policy as well as disciplinary policy. These may be specific to the clinical trial or apply broadly across the CRO, or Clinical (/Contract) Research Organization. Well-documented policies facilitate the CRPM’s role in sourcing and motivating the best-fitted staff to play different roles in the clinical team.

4. Clinical data management and quality control

The data from a clinical trial are often its most valuable project outcome. As such, effectively managing the input, storage, analysis and quality control of study data is one of the foremost responsibilities of a CRPM.

Before beginning the active phase of the clinical trial, a CRPM coordinates with team members to put in place the following aspects of data management:

  • physical data storage system (files, binders, shelves, cabinets, etc.)

  • electronic data capture (EDC) and management system

  • physical and electronic data security systems

  • data input procedure

  • data cleaning and quality monitoring procedure

  • data sharing (import, export, access across clinical sites and teams)

  • data analysis and visualization procedure

  • periodic data review and reporting procedure

5. Risk management and mitigation

Owing to the high stakes nature of clinical research, running a clinical research study carries numerous risks. One of the major responsibilities of a CRPM is to develop a risk management plan to identify and circumvent potentially risky situations, and to mitigate consequences to the project in cases where an unforeseen risk impacts the trials process.

Some sources of risk in the management of a clinical trial include:

  • failure to obtain or document subject informed consent

  • errors in following trial protocol (timing, dosage, subject screening, etc.)

  • data security breach leading to compromised subject confidentiality

  • inadequate insurance coverage for potential adverse events of study

  • financial constraints arising from changes in study funding

  • limitations on study scope due to revisions in regulatory policy

Bridging the gap: Using ACRPMC to transition from clinical research professional to project manager

The foregoing section outlined how, despite their strong base in clinical research, CRPM aspirants generally lack the advanced knowhow and managerial skills required for leading a clinical research project. CCRPS’ Advanced Clinical Research Project Management Certification (ACRPMC) provides an excellent tool for bridging this gap and bringing candidates up to speed in all domains of clinical research management.

The table below offers a summary of the focus areas of the ACRPMC, detailing how each contributes to enhancing a candidate’s expertise and eligibility for the role of a Clinical Research Project Manager.

ACRPMC Focus Area

Contribution to CRPM Candidate Eligibility

ADVANCED REVIEW - I:

Regulatory compliance in clinical research

i.Fundamentals of subject (/patient) safety, ICH-GCP E6, Sections 2 - 4

ii.Regulatory compliance – FDA-CFR Title 21, Forms FDA 1571, 1572, 3454, 3455

iii.Investigational New Drug (IND) & New Drug Application (NDA), Investigational Device Exemption (IDE)

iv.IRB, Data Safety Monitoring Board (DSMB)[8]






ADVANCED REVIEW - II:

Clinical trial concepts

i.Process & phases of clinical testing (pre-clinical and phases 1 to 4)

ii.Importance of ‘control’ in testing[9], outcome validity, control methods (randomization, blinding)

iii.Subject (/patient) selection[10]: screening & exemption criteria, selection & retention, study compliance

iv.Clinical trial data management[11]: EDC, Clinical Trial Management Systems (CTMS), Interactive Response Technology (IRT), Randomization & Trial Supply Management (RTSM)

v.Subject safety[12]: Risk assessment & Individual Case Safety Reports (ICSRs), Adverse Events (AEs), Adverse Drug Reactions (ADRs), Important Medical Events (IMEs)

ADVANCED REVIEW - III:

Pre-trial preparation

i.Documentation[13]: Regulatory binder, Investigator Brochure (IB), Trial Master File (TMF), Case Report Form (CRF), Delegation of Authority Log (DOAL), etc.

ii.Site preparation[14]: Site Selection Visits (SSVs), Site Qualification Visits (SQVs), site management agreements, investigator selection

iii.Pre-trial publicity: Advertisement for subject recruitment & retention






ADVANCED REVIEW - IV:

Active trial management & trial termination

i.Clinical trial protocol compliance, deviations & violations

i.Clinical site monitoring: subject safety, drug storage & safety, regulatory compliance

ii.Data monitoring: data security & access, Quality Management System (QMS), Quality Control (QC), Key Quality Indicators (KQI)

iii.Team monitoring: communication & collaboration, adherence to trial & safety protocols, research integrity & fraud

iv.Reviews & audits[15]: document & site audits, data audits, financial audits

v.Study termination: site close-out visits, data consolidation, subject debriefing

EXPERTISE BUILDING - I:

Clinical project management fundamentals

i.Project management basics[16]: key concepts, Project Management Body of Knowledge (PMBOK)

ii.Skills of a project manager: technical, administrative, human resources, public relations

iii.Clinical project stakeholders: sponsors, IRB, investigative & administrative staff, site administrators

EXPERTISE BUILDING - II:

Advanced clinical project management

i.Project planning & tracking, progress evaluation metrics

ii.Financial management[17]: project budgeting, site budgeting, advertising budget, payment tracking and management

iii.Risk management & problem solving[18]: problem solving managerial skills, identifying risks, avoiding failures, resolution of project problems (protocol deviations, compliance failures, project delays)

Fast-track to CRPM with the ACRPMC advantage

From the above summary table, it can be seen that the ACRPMC[19] program of CCRPS covers the entire spectrum of competencies required for managerial clinical research professionals. In addition to providing in-depth training in clinical project management concepts, tools and techniques, the program includes a review of foundational as well as advanced knowledge of the clinical trials process.

Aside from its comprehensive curriculum, certification through ACRPMC offers major benefits over conventional clinical research management courses, both online programs as well as those offered by colleges and universities. Some of the outstanding advantages of ACRPMC are:

1. Foundational review plus advanced training

The ACRPMC program stands apart from other online programs in its unique ability to launch as well as advance careers in clinical research. The program is equally effective at helping an aspiring graduate (BA in science or BS degree) to gain a competitive advantage in the clinical research job market, as it is at catapulting a senior clinical researcher into a managerial position. 

For CRPM aspirants in particular, the ACRPMC provides an unrivaled opportunity to brush up on the basics, in addition to acquiring valuable knowhow in clinical research project management, before embarking on the applications and interview process. 

2. Over 100 training modules (250 hours of coursework)

The course comprises over 100 modules. The advanced review focus areas address all aspects of the clinical research process, including important investigative concepts (trial design, randomization, subject screening, data analysis, etc.) as well as administrative processes (maintenance and updating of regulatory documents, case reports, trial logs, etc.). Additionally, the expertise building focus areas of the ACRPMC cover basic and advanced project management concepts and skills that equip candidates to tackle the challenges of leading a clinical research study.

3. ICH-GCP E6R2 compliant 

Designed by experienced Clinical Research Project Managers, the ACRPMC curriculum is fully compliant with the regulatory requirements of the ICH-GCP E6R2. The course coordinators additionally ensure that the content is regularly updated to reflect revisions to policy and new requirements.

4. Immediate enrollment and fast-tracked certification

Unlike college and university courses, trainees can enroll in the ACRPMC with just a few clicks. In addition, the self-paced course design allows students to skim through familiar topics, while giving more time and attention to new material. This is especially advantageous for working professionals and senior clinical research professionals wishing to refresh their knowledge. Trainees able to dedicate several hours per day to the program can complete the ACRPMC in as little as two weeks.

5. Multiple accreditations and industry-wide recognition

For ACRPMC-certified trainees, the solid credentials of the program confer a huge benefit when applying and interviewing for clinical research positions. Like other CCRPS courses, the ACRPMC is also accredited to ACCRE (Accreditation Council For Clinical Research and Education), ACCME (Accreditation Council for Continuing Medical Education) as well as ACPE (Accreditation Council for Pharmacy Education).

6. Clinical research résumé building and interview preparation 

The final modules of the ACRPMC help trainees in building their ability and confidence to face interviews for clinical research positions. Trainees completing the  comprehensive final examination not only have immediate access to a digital certificate, but are eligible to receive a letter of recommendation (LoR) that can strengthen their clinical research job application.

As the clinical research industry continues to grow at an unprecedented pace, there is rising demand for Clinical Research Project Managers who can blend their skill and  experience in clinical research with savvy, expert project management abilities. As a professional clinical researcher, the ACRPMC program offers you an unmatched opportunity to refresh existing knowhow and acquire new competencies, thereby leveraging your rise to the top echelons of management.

If you are a fresh graduate, the ACRPMC represents an unequaled, early-career edge in the clinical research arena. By equipping you with foundational as well as advanced knowledge and skills, ACRPMC certification does not merely improve your chances of securing an attractive clinical research position, it assures the rapid upward growth of your career graph.

Advanced Clinical Research Project Manager Certification (ACRPMC) program advantages.

References

  1. https://www.indeed.com/jobs?q=Clinical%20Trial%20Manager&l&vjk=311beece3c2d98b6

  2. https://www.payscale.com/research/US/Job=Clinical_Trial_Manager/Salary

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  6. https://ichgcp.net/8-essential-documents-for-the-conduct-of-a-clinical-trial

  7. Cullen H. 2016. Effective project management for clinical trials: A business approach. Ebook: https://www.imperialcrs.com/files/Project_Management_Ebook_Final.pdf

  8. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishment-and-operation-clinical-trial-data-monitoring-committees

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  11. von Itzstein MS, Hullings M, Mayo H, Beg MS, Williams EL, Gerber DE. 2021. Application of Information Technology to Clinical Trial Evaluation and Enrollment: A Review. JAMA Oncol. 7(10):1559–1566. DOI:10.1001/jamaoncol.2021.1165

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  13. https://files.nccih.nih.gov/s3fs-public/CR-Toolbox/Regulatory_Binder_Checklist_ver3_07-17-2015.docx

  14. https://www.appliedclinicaltrialsonline.com/view/selecting-study-appropriate-clinical-sites-3-steps

  15. https://www.clinicaltrialsarena.com/news/how-to-prepare-for-an-fda-site-inspection-5739632-2/

  16. PMBOK® Guide (7th ed.). 2022. Project Management Institute.

  17. Appleson M. 2015. The importance of budgeting in clinical trials and how a budget can prevent billing errors. Clin Invest. 5(5): 437-439. DOI: 0.4155/CLI.15.11

  18. Robinson M. 2005. Clinical trials risk management (1st ed.). CRC Press. DOI: 10.1201/9781420037654

  19. https://app.ccrps.org/courses/Advanced-Clinical-Research-Project-Manager-Certification

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