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Home » Clinical Trials Coordinator Professional Certification Program for CRCs

Clinical Trials Coordinator Professional Certification Program for CRCs

Certification Training
 
Rated 4.5 / 5
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Program/Course ID: CRCPRO
Enrollment Period: 12 months (1 year).
Average Learning Time: ~9 - 14 hours.
Additional Resources: Supplemental materials/activities.
Method of Training: Online / Self-paced eLearning.
Accessibility: 24/7 access to all program materials.
Courses: Program includes 6 individual courses (see courses).
Outline/Syllabus: See individual course pages for outlines.
Digital Badge: Issued upon completion.
Post-nominal Letters: CRCPro™.
Catalog: Clinical Trials Management and Monitoring.
Demonstration: Five (5) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment: Multiple choice; unlimited attempts.
Certificate: PDF with validation code (See sample).
  Price: $995.00 USD  

Document your dedication to compliance, safety, and job performance by earning a professional certification.

Biopharma Institute ReviewsTraining Provided By: Biopharma Institute
Website: https://www.biopharmainstitute.com

Outline/Syllabus: See individual course pages for outline.
Description:

The Clinical Trials Coordinator Professional Certification Program for CRCs provides a strong foundational understanding of clinical trails and all stakeholder responsibilities, with strong emphasis on the clinical research coordinators (CRCs) duties, good documentation practice, and how to prepare for a site audit. This program includes 6 courses.

The first course in the program describes Good Clinical Practice (GCP). This is a set of internationally recognized ethical and scientific quality requirements for designing, conducting, recording, and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorization of clinical trials and the acceptance of their data. The International Council for Harmonization's guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice. This course introduces GCP and sets it in the context of typical collaborative work in clinical research. We discuss the role and goals of the International Council for Harmonization and the principles of GCP. We describe the roles of members of a team working on a clinical trial. We set out the documentation that must be created and maintained. We specify the responsibilities of trial sponsors, clinical investigators, and monitors. We explain the rationale and execution of the informed consent process and discuss issues that arise in practice. The module is fully up to date with Revision 2 of ICH GCP.

The Investigator Site Personnel Good Clinical Practice (GCP) course covers the requirements of GCP for clinical trials found in ICH E6(R2) related to the role of the investigator and site personnel, such as clinical research coordinators (CRCs), and briefly covers roles of other stakeholders.

The Good Documentation Practices and ALCOA-C course, students will learn about Good Documentation Practices, including the ALCOA-C principles, notes to file, and other general documentation procedures. Good Documentation Practices are necessary to ensure product quality and product safety.

HIPAA Training for Clinical Trial Professionals course describes HIPAA's requirements for the use and disclosure of PHI during the conduct of a clinical trial is not simple and depends on the situation. But there is a way to use a core set of principles and questions that provide an ability to manage and facilitate the needs of all stakeholders. The regulatory authority of HIPAA and FDA agree that the two sets of regulations work well together. HIPAA does not restrict the GCP requirements of a site.

The Overview of ICH E8(R1) course describes how ICH E8(R1) is the umbrella guideline that maps to all the ICH E family, including ICH E6(R3), Good Clinical Practice. The revision modernizes clinical trial design, planning, management, conduct, and reporting and introduces the idea of quality as data being fit for purpose, which is ensuring the protection of study participants, the integrity of the data and reliability of the results, and the ability of the trials to meet their objectives.

Good Clinical Practice (GCP) inspections and audits are carried out to provide assurance that: the rights, safety and welfare of clinical trial subjects are protected; the data that constitute the results of the trials are accurate and reliable; and the trials are carried out in compliance with relevant legal requirements. This last course in this program, Preparing for an Audit or Inspection, describes what investigational medicinal product sponsors, contract research organizations and clinical investigators can expect when they undergo inspection or audit. It focuses in particular on inspection by European and US regulators. The course describes general principles of GCP inspection and audit, discusses preparation for an inspection, and sets out in detail what European and US FDA inspectors will examine. Finally it describes post-inspection actions by the regulator and the inspected party.


Clinical Trials Coordinator Professional Certification Program for CRCs includes these 6 individual courses:

(Click on course links below to see outline/syllabus)



Individual Course w/Certificate of Completion:

GCP: ICH-GCP Good Clinical Practice

Course ID: GCP001
Duration: 180 minutes (3 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Clinical Trials: Preparing for an Audit or Inspection

Course ID: GCP006
Duration: 150 minutes (2.5 CPD Credits)
Price: Included | Learn more

Individual Course w/Certificate of Completion:

ICH E6(R2) GCP Training for Investigator Site Personnel

Course ID: CP004a
Duration: 60 minutes
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Overview of ICH E8(R1): General Considerations for Clinical Studies Guideline

Course ID: CP019a
Duration: 45 minutes
Price: Included | Learn more

Individual Course w/Certificate of Completion:

Good Documentation Practices and ALCOA-C

Course ID: CP005a
Duration: 60 minutes
Price: Included | Learn more

Individual Course w/Certificate of Completion:

HIPAA Training for Clinical Trial Professionals

Course ID: CP017a
Duration: 60 minutes
Price: Included | Learn more

Additional Information:

Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessments for each course within a 12-month period. Certificate of completion is accessible in PDF format immediately after satisfying the requirements.

Biopharma Institute certificates and digital badges include the date of completion, but do not have an expiration date. However, compliance training is typically considered valid for a period of 3 years. Many organizations suggest that compliance training should be refreshed at least every three years to stay up to date with regulations, standards, guidelines, and to reinforce the importance of maintaining compliance. The validity or recertification period for employee compliance training would be determined by those responsible for managing quality within the company.

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student following enrollment into any program or course. Students may attempt the final assessments any number of times, as needed, to achieve a passing score.

Once all training requirements have been satisfied a professional certification has been achieved and can be verified immediately from our website using a unique ID code located on the certificate. The professional certificate of completion is also instantaneously launched and made available to the student in a PDF format.

Additionally, once the student has completed the professional certification program, a digital badge is issued. The digital badge documents all the courses taken and completed within the program, to further validate the student's achievement. Digital badges can be displayed on social networking sites, such as LinkedIn, Facebook, Badgr, and others, to display the accomplishment.

Benefits of Being Certified from Biopharma Institute: Throughout the online training courses students will be engaging in active learning using interactive eLearning modules developed to promote the retaining of key knowledge. Furthermore, students will be provided with access to references, the regulatory guidelines, case studies, and other important information necessary to gain a professional understanding for the discipline.

Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with attaining their training requirements. Our courses are developed by subject matter experts (SMEs) in the topic of study and have all been validated and/or accredited by a neutral 3rd party. Biopharma Institute certifications are recognized by regulators and companies in a wide range of industries around the world.

Biopharma Institute has training solutions which are customizable to any organization's training needs. We aim to provide only the highest quality of training, which is current, engaging, effective, and easy to navigate.

Today, Biopharma Institute has over 200+ courses in its catalog. These courses train on clinical trials, drug manufacturing, regulatory affairs, validation systems, drug safety, pharmacovigilance, good laboratory practice, and data integrity; all within the medical device, clinical research, and pharmaceutical industries.

Employee / Corporate Training: For corporations seeking a method to train employees, economically, without having to set aside time for travel, webinars, or live, in-person training, Biopharma Institute is the training partner you can rely on. Our training provides an effective, engaging, self-paced learning experience which fits conveniently into the day-to-day activities of most types of learners. Our eLearning modules are SCORM-compliant and can be delivered from most corporate learning management systems (LMS). We catering to both small and large-scale training requests.


Benefits of Training with Biopharma Institute

  • Immediate access to training: Instructions, username, password, and receipt of payment are emailed instantly upon online enrollment.
  • Self-paced courses: 24/7 access to individual courses for 6 months and 1 year for professional certification programs.
  • Expertise: All courses have been developed by subject matter experts (SMEs) in the area of material being taught.
  • Current and validated: All courses are current with respect to regulations and procedures, and are 3rd party validated and/or accredited.
  • Optimized for learning: Courses include voiceovers, easy navigation, case studies, progress checks, and high-quality animations to increase retention of subject matter.
  • Secure and safe access: Website and LMS provide an encrypted connection with firewall protection and daily scans for malware to deliver optimal level of security and performance.
  • Training manager access: Our proprietary Training Manager Portal offers managers access to download their group enrollments, training records, account balance, and so much more.
  • Purchase orders (POs): If issuing a PO is required by your company, request an invoice to start the procurement process.
  • Corporate LMS compatibility: All courses are SCORM compliant and can be delivered from most corporate Learning Management Systems.
  • Reimbursement: Some employers may reimburse for training expenses. Check your company's training reimbursement policy.
  • Financial assistance: Payment plans are available to those who qualify. These are offered when paying electronic invoices, online. You must first request an invoice to be considered. Alternatively, purchasing individual courses one at a time is also an option.
  • Flexible final assessments: Assessments include multiple-choice questions and can be taken repeatedly until a passing score is achieved.
  • Career advancement: Professional certifications help demonstrate your interest and dedication to your career and job performance. They may be helpful for those seeking a new career or transitioning to different positions within their organization.
  • Direct access to certificates: Certificate of completion is instantly available once requirements have been fulfilled.
  • Verification of training: Certificates can be verified online, and digital badges are issued for all professional certification programs.


Have Questions? Contact Us:

Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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For quotes or invoices please provide the course(s) and number of students.