Top 10 Study Coordinator Certifications

Certifications are important for a study coordinator because they can help to set them apart from other job candidates. Certifications demonstrate knowledge and expertise in the field, and they provide employers with evidence that a candidate has the necessary skills and qualifications needed to succeed in the role. Additionally, certifications can be used to demonstrate commitment to career development, which is an attractive quality for employers. Finally, certifications may also open up new opportunities for advancement within a company or organization.

The purpose of this article is to review the top certifications for study coordinators and explain how they can help enhance their career prospects.

What are Study Coordinator Certifications?

Study coordinator certification is a type of professional certification that is designed to provide study coordinators with the knowledge and skills needed to support clinical research studies. This type of certification is offered by many organizations, including the Association of Clinical Research Professionals (ACRP) and the Society for Clinical Research Associates (SOCRA).

The primary purpose of study coordinator certification is to ensure that those who work as study coordinators are knowledgeable about the best practices associated with clinical research. This includes topics such as regulatory compliance, protocol design, data management, and ethics. By successfully completing a study coordinator certification program, individuals demonstrate that they have an understanding of how to perform their job duties in accordance with established standards.

Having study coordinator certification can be beneficial for both employers and employees. For employers, it provides assurance that their staff members are qualified to carry out their duties correctly and safely. It also helps employers identify potential candidates who possess the necessary knowledge and skills for the position. For employees, having this type of certification can help them stand out from other applicants when applying for roles in clinical research, as well as give them an advantage when seeking promotions or pay increases. Furthermore, it can also serve as evidence that they have invested in their own professional development.

Pro Tip: When considering study coordinator certification, research the requirements and regulations for becoming certified in your specific area. Make sure that you understand what type of training is needed and how long it will take to become certified. Additionally, consider any additional costs associated with certification and take advantage of any available resources or continuing education opportunities to help you stay up to date on best practices.

Related: What does a Study Coordinator do?

Top 10 Study Coordinator Certifications

Here’s our list of the best certifications available to Study Coordinators today.

1. Certified Clinical Research Coordinator (CCRC)

A Certified Clinical Research Coordinator (CCRC) is a professional who has been trained and certified to coordinate and manage clinical research studies. The CCRC credential is offered by the Association of Clinical Research Professionals (ACRP).

In order to become a CCRC, an individual must have at least two years of full-time clinical research experience in one or more of the following areas: regulatory affairs, data management, study coordination, monitoring, quality assurance/quality control or site management. They must also pass the ACRP Certification Exam.

The ACRP Certification Exam consists of 150 multiple-choice questions that cover topics such as Good Clinical Practice (GCP), ethics and compliance, study design and implementation, data management and reporting. The exam takes approximately three hours to complete and costs $400 for members of ACRP and $500 for non-members.

2. Certified Principal Investigator (CPI)

Certified Principal Investigator (CPI) is a credential that recognizes the expertise and experience of research professionals. It is awarded by the Association of Clinical Research Professionals (ACRP) to individuals who have demonstrated their knowledge and understanding of clinical research principles and practices.

To qualify for the CPI, applicants must meet certain criteria including having at least two years of relevant work experience in clinical research, completing an ACRP-approved training program, passing an examination, and maintaining continuing education requirements. The entire process typically takes between six months to one year from start to finish.

The cost of obtaining the CPI credential varies depending on the type of training program chosen. Most programs range from $2,000 to $4,000. In addition to the cost of the program itself, there are also fees associated with taking the exam and maintaining certification.

Overall, obtaining a CPI credential can be a valuable investment for those looking to advance their careers in clinical research. It demonstrates a commitment to professional development and provides recognition as an experienced and knowledgeable practitioner in this field.

3. Certified Clinical Data Manager (CCDM)

Certified Clinical Data Manager (CCDM) is a professional certification program designed to recognize individuals who demonstrate a high level of knowledge and expertise in the field of clinical data management. The CCDM program is administered by the Society for Clinical Data Management (SCDM).

The CCDM program consists of two parts: an online exam and a hands-on practicum. The online exam covers topics such as data management principles, data collection, coding, database design, data validation, and quality assurance. The practicum requires applicants to complete a series of tasks related to clinical data management in an actual clinical setting.

It typically takes three to six months to complete the CCDM program. Applicants must pass both the online exam and the practicum with a score of 80% or higher in order to be certified.

The cost for the CCDM program varies depending on where you take it. Generally speaking, it costs around $2,000-$3,000 USD for both parts of the program. This includes all materials needed for study and preparation as well as registration fees for the exam and practicum.

In addition to passing both parts of the CCDM program, applicants must also have at least two years of experience in clinical data management before they can apply for certification.

4. Certified Regulatory Affairs Professional (CRAP)

Certified Regulatory Affairs Professional (CRAP) is a professional certification program designed to recognize individuals who have demonstrated a high level of knowledge and experience in the field of regulatory affairs. The CRAP certification is awarded by the Regulatory Affairs Professionals Society (RAPS).

The CRAP certification requires applicants to have at least five years of regulatory affairs experience, including two years of direct involvement in regulatory submissions or activities. Applicants must also pass an exam administered by RAPS that covers topics such as global regulatory requirements, product development, quality systems, and compliance.

The CRAP certification process typically takes six to nine months from start to finish. During this time, applicants must complete an application form, submit their resume and supporting documents, take the exam, and receive their results.

The cost for the CRAP certification program varies depending on the applicant's country of residence. In the United States, it costs $1,500 for members and $2,000 for non-members. In Canada, it costs $1,800 for members and $2,400 for non-members. The fee includes access to study materials and practice exams as well as the exam itself.

5. Certified Quality Assurance Professional (CQAP)

A Certified Quality Assurance Professional (CQAP) is a professional designation awarded by the American Society for Quality (ASQ). The CQAP credential demonstrates that an individual has attained a high level of knowledge and experience in quality assurance practices.

The CQAP certification process consists of two parts: an online application and an examination. The online application requires applicants to provide information about their education, work experience, and other qualifications related to quality assurance. Once the application is approved, applicants can register for the exam.

The CQAP exam consists of 150 multiple-choice questions covering topics such as quality management systems, process improvement, statistical analysis, problem solving, and customer satisfaction. Applicants must answer at least 70% of the questions correctly in order to pass the exam and become certified.

It typically takes between 6-9 months to complete all requirements for the CQAP certification. However, this timeline may vary depending on how quickly applicants are able to complete their application and prepare for the exam.

The cost of obtaining the CQAP certification varies depending on whether or not you are an ASQ member. For non-members, it costs $399 USD to take the exam; for members, it costs $299 USD.

6. Certified Clinical Research Associate (CCRA)

A Certified Clinical Research Associate (CCRA) is a professional certification that demonstrates expertise in the field of clinical research. The CCRA certification is offered by the Association of Clinical Research Professionals (ACRP), an international membership organization for clinical research professionals.

The CCRA certification requires a minimum of two years of full-time experience in the field, and successful completion of an ACRP-administered exam. The exam covers topics such as Good Clinical Practices, ethical considerations, regulatory requirements, and data management.

To obtain the CCRA certification, applicants must first become an ACRP member and then register for the exam. The cost to become an ACRP member is $50 USD per year, and the cost to take the exam is $450 USD. Once registered for the exam, applicants have up to one year to complete it.

Successful completion of the CCRA certification requires passing scores on both a multiple-choice test and a written case study analysis. Upon successful completion of the exam, applicants will receive their CCRA certificate from ACRP.

7. Certified Clinical Trials Auditor (CCTA)

A Certified Clinical Trials Auditor (CCTA) is a professional credential that provides recognition of an individual’s expertise in auditing clinical trials. The CCTA certification is offered by the Association for Clinical Research Professionals (ACRP).

It typically takes about 6 months to complete the requirements for the CCTA certification, which includes completing an online application and passing a written examination. The cost of the CCTA certification is $1,295 and includes the exam fee, study materials, and access to ACRP resources.

To be eligible for the CCTA certification, applicants must have at least 5 years of experience in clinical research or related fields such as quality assurance, regulatory affairs, or data management. Applicants must also have a minimum of 2 years of experience in auditing clinical trials or related activities such as monitoring or site visits. In addition to these requirements, applicants must also have 40 hours of continuing education credits in clinical research-related topics within the past 3 years.

8. Certified Drug Safety Specialist (CDSS)

Certified Drug Safety Specialist (CDSS) is a professional certification for individuals who have the knowledge and skills to ensure the safe use of drugs. It is offered by the National Institute for Drug Abuse (NIDA).

To get certified, applicants must meet certain criteria, including having at least two years of experience in drug safety or related fields. They must also pass an exam that covers topics such as pharmacology, clinical trials, adverse event reporting, and risk management. The exam consists of multiple-choice questions and takes about two hours to complete.

The cost of the CDSS certification varies depending on the provider. Generally, it costs between $200 and $400 USD to take the exam and receive the certification.

Once certified, individuals must renew their certification every three years in order to maintain it. This involves completing continuing education courses related to drug safety and passing a recertification exam.

9. Certified Medical Monitor (CMM)

A Certified Medical Monitor (CMM) is an individual who has been certified by a recognized accreditation body to oversee and manage clinical trial activities. The CMM is responsible for ensuring that the clinical trial is conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, and the protocol. The CMM also monitors patient safety, data quality, and integrity of the study results.

The process of becoming a CMM typically takes several months and involves completing an accredited education program, passing an exam administered by the accrediting body, and gaining experience in clinical research. Depending on the accrediting body, additional requirements may be necessary.

In order to become a CMM, individuals must first complete an accredited education program such as those offered by organizations like the Association of Clinical Research Professionals (ACRP). After completing the program and passing the exam administered by ACRP or another accrediting body, individuals must then gain experience in clinical research through internships or other programs.

The cost of becoming a CMM varies depending on the accrediting body but typically ranges from $500 - $2,000 USD for all associated costs including tuition fees for educational programs and exam fees.

10. Certified Good Clinical Practice Professional (CGCPP)

Certified Good Clinical Practice Professional (CGCPP) is a certification program that provides professionals in the clinical research industry with the knowledge and skills necessary to ensure compliance with Good Clinical Practice (GCP) guidelines. GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.

The CGCPP certification program consists of a series of online courses and assessments designed to provide professionals with the knowledge needed to understand and apply GCP principles in their daily activities. The program also includes an exam that must be passed in order to earn the CGCPP credential. The exam covers topics such as regulatory requirements, ethics, data management, monitoring, auditing, and reporting.

The CGCPP certification program typically takes approximately four months to complete. It begins with an online orientation course followed by six core courses covering topics such as GCP principles, risk-based monitoring, auditing techniques, and data management. After completing all seven courses, students are required to pass an online assessment before taking the final exam.

The cost of the CGCPP certification program varies depending on the provider but typically ranges from $500-$1000 USD.

Do You Really Need a Study Coordinator Certificate?

The short answer is no, you do not need a Study Coordinator Certificate to become a study coordinator. However, if you are looking to increase your chances of landing the job and standing out among other applicants, then having one may be beneficial.

A Study Coordinator Certificate shows employers that you have the necessary skills and knowledge to effectively coordinate studies. It can demonstrate that you understand the complexities of clinical research and are capable of managing multiple tasks with accuracy and efficiency. Employers may also be impressed by the fact that you have taken initiative to gain specialized knowledge in this field.

Having a certificate can help you stand out from other applicants who may not have any formal training or education related to study coordination. This can give you an edge in the job market and make it easier for employers to recognize your qualifications for the position. Additionally, having a certificate could open up opportunities for advancement and higher pay rates down the line as well.

Overall, obtaining a Study Coordinator Certificate is not essential but can give you an advantage when applying for jobs in this field. It is important to consider what kind of experience and qualifications are required by potential employers when deciding whether or not getting certified is worth it for your career goals.

Related: Study Coordinator Resume Examples

FAQs About Study Coordinator Certifications

Q1: What is a Study Coordinator Certification?

A1: A Study Coordinator Certification is an accreditation that demonstrates a professional's knowledge and experience in managing clinical research studies. It provides employers with assurance that the individual has the skills necessary to coordinate and manage clinical trials safely and efficiently.

Q2: How do I become certified as a Study Coordinator?

A2: To become certified as a Study Coordinator, you must complete an approved study coordinator training program, pass a written exam, and meet any additional requirements set by your employer or certification body.

Q3: What are the benefits of becoming a certified Study Coordinator?

A3: Becoming a certified Study Coordinator can open up career opportunities, demonstrate your expertise to potential employers, and provide you with professional recognition for your skills. Additionally, it can help you stay current on best practices in the field of clinical research.

Q4: How long does it take to become certified as a Study Coordinator?

A4: It typically takes 8-10 weeks to complete an approved study coordinator training program and prepare for the written exam required for certification. The length of time can vary depending on the program you choose.

Q5: Are there continuing education requirements for maintaining my certification?

A5: Yes, most certification bodies require that you complete continuing education credits each year in order to maintain your certification.