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Clinical Research - Gratisol Labs

What is Clinical Research Certification?

Clinical Research Professionals (CRPs) come from many backgrounds, ranging from nursing and pharmacy to business administration/statistics and many more. Clinical Research Professionals work in a wide range of settings as well, including cancer centers, academic and private institutions and various organizations. These varying experiences contribute to CRPs unique knowledge and expertise in the research industry.

These Clinical Research Professionals may become certified in their roles through various examinations provided by organizations such as The Association of Clinical Research Professionals (ACRP) or The Society of Clinical Research Associates (SOCRA). Certification establishes a standard of knowledge, education and experience is recognized by the clinical research community. The standards in place are set to promote recognition and continuing excellence in the ethical conduct of clinical trials.

The principles on which the evaluations are conducted were created in accordance with previously established standards and definitions of Good Clinical Practice (GCP). The Clinical Research Professional certification process reflects a common strong foundation of knowledge and practice in research regulations and GCP.

Clinical research is the fastest growing discipline in the burgeoning medical device and pharmaceutical industries. Keeping pace with the ever-increasing body of knowledge and new regulatory procedures generated by advances in clinical research is critical to career success.

What are the advantages of certification?

Professional Advancement

  • Certified CRPs can take their profession to another level by becoming well-versed in the core body of knowledge defined by the certifying body.
  • Commitment to ongoing professional development and expanding their knowledge and area of expertise.
  • Gaining skills through rigorous certification and assessment necessary to lead in their field.
  • Demonstrating their competence as a qualified, ethical clinical research professional as validated by a third party; also verifying their ability to apply standards to their profession.

Commitment to Quality Standards

  • Commitment to following a code of ethics defined by the certifying body.
  • Commitment to protection of human subjects.
  • Compliance with regulations and quality of the data collected.

Clinical Research Certification sets apart from the Crowd

  • CRPs who gain certification show their commitment to the internationally-recognized standards set themselves apart from those who do not have certification.
  • Individuals who are certified may use certified clinical research professional (CCRP) designation to help facilitate career advancement including greater responsibilities, leadership opportunities and recognition.

How to get Certified

Certifications vary depending on the organization providing the assessment. SOCRA provides one general certification for Clinical Research Professionals: the CCRP program. This certification is offered to all persons working in clinical research regardless of whether they are independent or affiliated with a research institution/CRO/SMO/sponsor or government provided the applicant meets the eligibility requirements.

Certificate programs offer students many benefits. This opportunity typically takes several months to one year of work to complete and combines extensive training with comprehensive subject coverage. Clinical Research Training is normally supported with opportunities to develop and apply the skills in related occupations.

What is a certificate in clinical research? Depending on the focus of the clinical research certificate program you choose, you may take classes in bio-statistics, ethics, clinical research methodology, economics and health policy. Once you have basic clinical research knowledge, you may choose to break out into more specialized areas of focus, such as research studies in bioinformatics or clinical trials in the pharmaceutical industry.

By earning their certificate, students may gain skills that are beneficial in their professional and personal lives. They can learn new proficiency that may lead to more career options and advanced salaries. It is also a way to get started in a discipline without committing to a diploma program.

When you earn a certificate in clinical research, you may find career opportunities in the healthcare field, clinical research organizations and the pharmaceutical industry. You may learn many of the skills essential for conducting clinical research, applying statistical theories and analyzing the data and results that may help propel an exciting career as a clinical trial researcher or member of an institutional review board or independent ethics committee.

Students may take classes on a full- or part-time basis. Interactive online platforms are available in a simple, easy-to-use format that cater to busy professionals at most schools. To find the right school for you, search for your program below and contact directly the admission office of the school of your choice by filling in the lead form.

ACRP, on the other hand, provides specialized certification programs for different clinical research roles that all have different requirements for application. They provide six separate certification programs depending on your role in the clinical research industry, each with separate examinations and designations.

ACRP offers specific examinations and certifications for different research professionals including Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), Certified Principal Investigator (CPI), ACRP Certified Professional (ACRP-CP), ACRP Medical Device Professional Subspecialty (ACRP-MDP), and ACRP Project Manager Subspecialty (ACRP-PM) programs.

Although there are many clinical research certification programs online, always be sure to confirm that the program is reputable and widely accepted within your field before continuing.

Gaining clinical research certification can offer many benefits in the field – rigorous application review and examination demonstrates to potential employers your specific skillset and experience necessary to succeed in a given role.

Clinical research is the fastest growing discipline in the burgeoning medical device and pharmaceutical industries. Keeping pace with the ever-increasing body of knowledge and new regulatory procedures generated by advances in clinical research is critical to career success.

The objective of the program is to provide an in-depth understanding of the scientific fundamentals of human research.

The Curriculum provides an in-depth understanding of key, fundamental elements of clinical research, including:

  • Clinical trial design and conduct
  • Clinical research regulations
  • Good clinical practices of research
  • Critical evaluation of the medical, research literature

Who can benefit from this program?

– Clinical and health professionals of all varieties, including:

  • physicians, dentists
  • research nurses
  • study coordinators,
  • managers in clinical research and site management,
  • professionals in the pharmaceutical, biotechnology, and medical device industries, as well as CRO and SMO organizations

Benefits of this program:

  • Earn a Certification from Industry Leader Gratisol Labs, a leading research institution in Clinical Research Industry
  • Qualify to sit for the Association of Clinical Research Professionals (ACRP) Clinical Research Coordinator exam and waive the two-year work requirement

The certificate program consists of four online courses that explore:

Designing Clinical Research Studies

This course covers important scientific and epidemiologic principles necessary for designing clinical research studies. Topics include bias, confounding, developing the research question, defining an appropriate study population, choosing outcome measures, clinical research ethics, and regulation, and statistical analysis issues.

 Good Clinical Practices

Introduces regulatory responsibilities of sponsors, monitors, and investigators conducting clinical trials. Practical information and exercises are designed on GCP compliance from an industrial perspective. Topics include: selecting qualified investigators; obtaining ethical approval for patients and initiating sites successfully.

Regulatory and Compliance Issues

Explains the regulatory requirements for healthcare products, that is, drugs, biologics, diagnostics, and devices. Intended for those interested in regulatory affairs or in the clinical evaluation, development, manufacture, testing and/or commercialization of these products. Provides an in-depth review of pertinent FDA regulations and guidelines and relationship to scientific and logistical activities involved in taking a product from research to market. Content and preparation of regulatory submissions, including an Investigation New Drug Application (IND), an Investigational Device Exemption (IDE), a New Drug Application (NDA), a Biologic License Application (BLA), a Pre-Market Approval Application (PMA), and a 510K Pre-Market Notification are described. International requirements for healthcare products are also reviewed.

Critical Evaluation of the Medical Literature

Provides students experience in reading and critically evaluating current research published in the medical literature pertinent to the origination, design, implementation, and evaluation of clinical research.

Benefits of learning online

Interactivity

Gratisol Labs Online programs are filled with activities, videos, and simulations to ensure that students get the most out of their experience. Students participate actively in each course through a variety of means, including online discussions, quizzes, and assignments.

Flexibility

Versatility is a key feature of Gratisol Labs Online courses and programs. Online course materials are available twenty-four hours a day, seven days a week, from any location. Which means that students can learn where and when it works best—for them. Each student determines which hours are best for studying, attending lectures, and completing assignments. Though students must complete course requirements within an established time frame, the actual hours spent meeting those requirements are mostly at the convenience of each individual.

International Certifications:

  • CCRA – Certified Clinical Research Associate (CRA Certificate Course ) 
  • CCRC – Certified Clinical Research Coordinator (CRC Certificate Course) 
  • CCDM – Certified Clinical Data Management  ( CDM Certificate Course) 
  • CCRPV – Certified Clinical Research & Pharmacovigilance Professional   ( PV Certificate Course) 
  • RA – Certified Regulatory Affairs Professional ( CRP Certificate Course) 

Course Level Certifications Diplomas: (For all Regular Courses)

  • PG Diploma (6 Months– Life-Sciences Skill Development Certification Program)
  • Advanced Certifications (3 Months – CR, CDM, RA & PV)
  • Certification Courses (45 days – 60 days –  Skill Enhancement for Industry Professionals & Graduates)

A Clinical Research Associate (CRA) is a professional who monitors clinical trials and research studies. CRAs can be either employed by a Pharmaceutical or Biotech Company, Contract Research Organization (CRO), Independent Consultant or may act as freelancers. CRAs practice FDA-approved methodology, monitor clinical trials and ensure that clinical trials adhere to established guidelines, regulations and Standard Operating Procedures (SOP’s). The CRA is independent of the clinical investigator sites and must not have any conflict of interest that may potentially influence their ability to monitor clinical trials. CRAs play a key role in the development of all drugs and devices that make it to the market.

Benefits of CRA Training & Certification:

Sponsors, CROs and other agencies involved in the conduct of clinical trials and other types of medical research are increasingly looking for certified individuals who have undergone standardized and validated training and certification so that they can be relied upon to manage the tasks given to them. The performance of a CRA is critical to the success of a project. Companies or organizations that are involved in the conduct of clinical trials must follow regulations and guidelines that define the quality of data generated by clinical research sites, the manner in which data is collected and handled, and the protection of research subjects, to name a few. The CRA Training & Certification Program which leads to the award of Gratisol Labs Certified Clinical Research Associate helps new or seasoned CRAs to demonstrate their professional excellence through a validated training & certification process. This goes a long way to be a great value addition to their background, education, work experience and demonstrates adequate training in clinical research. CRA Certification also provides for personal satisfaction and increased recognition by peers, supervisors and the industry at large.

Eligibility:
In order to be eligible for this certification program, applicants have to have a combination of
educational background that they either obtained online or at a college campus and a substantial amount of work experience. If you do not hold a basic science background but have obtained a related qualification such as a Master of Health Care Administration or any other health care related degree and worked in a completely different setting, you are still eligible for this certification program and for employment in future. Usually the applicants must suffice the eligibility requirements as per one of the categories listed in the table below.

CATEGORY EDUCATION WORK EXPERIENCE IN PERFORMING CORE CRA TASKS * (IN HOURS) DOCUMENTS REQUIRED ( ALONG WITH APPLICATION OR WITHIN 7 DAYS OF APPLICATION)
1
Bachelor’s Degree OR
Master’s Degree OR
Registered Nurse (RN)
2800
Detailed CV/Resume AND
Job Description submitted along with online application or within 7 days of application through email.
2
Bachelor’s Degree OR
Master’s Degree OR
Registered Nurse (RN) AND
Completion of an education program of more than 150 hours in clinical research
1400
Detailed CV/Resume AND
Job Description AND
Certificate of completion of clinical research education program submitted along with online application or within 7 days of application through email.
3
Associates Degree
4200
Detailed CV/Resume AND
Job Description submitted along with online application or within 7 days of application through email.
4
Associates Degree AND
Completion of an education program of more than 150 hours in clinical research
2800
Detailed CV/Resume AND
Job Description AND
Certificate of completion of clinical research education program submitted along with online application or within 7 days of application through email.
5
High School Diploma OR
LPN/LVN/Medical Assistant/ Research Assistant
5600
Detailed CV/Resume AND
Job Description submitted along with online application or within 7 days of application through email.
6
High School Diploma OR
LPN/LVN/Medical Assistant/ Research Assistant AND
Completion of an education program of more than 150 hours in clinical research
4200
Detailed CV/Resume AND
Job Description submitted along with online application or within 7 days of application through email.

CRA Training & Certification Program Structure:

After registering for the CRA Training and Certification program, members are provided access to the Gratisol Labs learning and certification portal. The online CRA Training & Certification program is a 40 hour structured program that delivers core trainings in the area of clinical study conduct. Following are some of the important areas in which training is provided after signing up for the certification program.

Introduction:

This study module that comprises of multiple lectures and presentations introduces the individual to the pharmaceutical and clinical research industry.
It also provides for a comprehensive assessment of the clinical research industry and the history and milestones that have led to the present clinical research landscape. The introductory module also educates the individual on the stakeholders in clinical research and the Principles of Good Clinical Practice (GCP). Technologies in clinical trial management are discussed in detail, and the individual also is provided comprehensive knowledge on the major clinical research regulatory bodies that exist globally.

Drug Development:

This module comprises of multiple lectures and provides training on Pre-clinical development of drugs and biologics, various phases of clinical drug development, clinical trial designs and endpoints in clinical trials. Various clinical trial registries in use today will also be reviewed in detail in this module.

Ethics in Drug Development:

This module that comprises of multiple lectures explains the concept of ethics in clinical research, Informed Consent Process, Documentation and HIPAA and also provides training in International Conference on Harmonization (ICH).

Regulations in Clinical Research:

This module provides training in FDA regulations such as 21 CFR Parts 11, 50, 54, 56, 312,812, and 814.

Roles & Responsibilities:

It is critical that responsibilities be defined for all stakeholders in the management of clinical trials, so that expectations that are reasonable can be defined. This module provides comprehensive understanding of the responsibilities of the clinical investigator, sponsors, vendors and Institutional Review Boards (IRB).

Essential Documents:

Essential Documents are documents, which individually and collectively permit evaluation of the conduct of a trial and the quality of the data generated. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.
One of the most critical and common inspection finding during investigator site inspections is the inadequacy of reliable and accurate source documentation. This also happens to be the most common pitfall identified during sponsor audits. The importance of good documentation practice needs to be stressed to investigator sites to ensure that the study results are built on the foundation of credible and valid data. This module focuses on the key principles of good documentation practice, provides intensive training on important areas such as source documentation, essential documents, IND & NDA Applications, and the clinical study report (CSR).

Study Start-Up:

This module provides an overview of clinical operations in the study start-up phase of a clinical trial. From final protocol to first patient visit, a Study Start-Up Team must be formed, vendors and sites selected and activated, processes established for data collection and reporting, and regulatory approvals obtained. This module provides focused training on areas such as feasibility assessment, site selection, pre-study visit, site initiation, subject recruitment and retention, trial master file (TMF) and clinical trials budgeting.

Study Monitoring & Close Out:

The monitor’s responsibility is to “monitor the conduct of a research trial”.
Study monitors must have a thorough understanding of the Code of Federal Regulations, local laws, guidelines and their assigned study protocols. A major part of the monitor’s responsibilities is to advise and assist sites in adhering to FDA and other local and international regulations and/or guidelines while also helping them meet the requirements of particular research studies. Monitors serve both as communication conduits between sites and sponsors, and as managers for individual research projects. This module provides comprehensive training in areas such as routine site monitoring, CRF review and source data verification, drug accountability and compliance, site close out, writing effective monitoring reports and follow-up visit letters, and document archival and maintenance.

Safety Reporting:

One of the most important responsibilities of the CRA is to ensure that clinical investigators are fully aware of, and are in compliance with their responsibilities for adverse event reporting. To achieve this, the CRA must often teach the adverse event reporting requirements to investigators. As a result, the CRA must be knowledgeable about both the regulatory and sponsor-specific requirements for reporting serious and non- serious adverse events in clinical trials. This includes the correct use and completion of the adverse event forms, and definitions and terms of reporting adverse events that may extend beyond the regulatory requirements. This module provides training on documenting and reporting adverse and serious adverse events in clinical trials.

Role of Quality Assurance & Data Management:

This module provides relevant training in Quality Assurance (QA) Audits and Inspections, Electronic Records and Signatures, Data Management and Biostatistics.

Certification Examination:

Gratisol Labs has partnered with S2J Independent Ethics committee  to offer exams for all Certification Programs. To ensure integrity, security & consistency of the examination process, real people oversee proctored exams. Proctored exams are a required component of the certification programs at Gratisol Labs. You can schedule an examination at your convenience after registering for the exam and paying the examination fee of USD 27/-  on the gratisol.com website. Scheduling of examinations will not incur any additional cost unless the exam is scheduled within 3 days of the date of scheduling. The certification examination will be of 2 hour duration. While the training provided though our CRA training program is extensive and broad in scope, members are nevertheless tested on their understanding of GCP and site monitoring based upon other resources that he/she may have been directed to during their training. These resources may include the FDA website, international and/or local policies, regulations, and guidelines, best practices, etc. We provide an exhaustive list of such resources through our Learning & Certification Portal.

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