Student Login |


Tuesday, March 19, 2024
Home » Clinical Research Associate (CRA) Professional Certification Program

Clinical Research Associate (CRA) Professional Certification Program

Clinical Research Associate (CRA) Professional Certification Program Certification Training

 
Rated 4.2 / 5
(10 reviews)

Program/Course ID:GCP00A
Enrollment Period:12 months.
Average Learning Time:~8 - 11 hours.
Additional Resources:Supplemental materials/activities.
Method of Training:
Online, asynchronous, self-paced eLearning.
Accessibility:24/7 access to all program materials.
Courses:5 courses included.
Outline/Syllabus:See individual course pages for outlines.
Digital Badge:Issued upon completion.
Post-nominal Letters:CMPro™
Catalog:Clinical Trials Management and Monitoring.
Demonstration:Four (4) free trial courses are available.
Group/Employee Training: Click here to request a quote.
Final Assessment:Multiple choice; unlimited attempts.
Certificate:Encrypted PDF with validation QR barcode.
Special New Year 25% Discount:Use this discount code: 2024NEWYEAR.
Discounted Price:
   $633.75 USD  
  Price: $845.00 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:

GCP, or Good Clinical Practice, refers to a set of scientific and ethical quality standards for reporting, recording, conducting, and designing trials that involve human subjects. GCP compliance ensures the well-being, safety, and the rights of clinical trial subjects, as well as the integrity and credibility of clinical trial data. E6-GCP defines monitoring as, "The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s)".

The sponsor of a clinical trial needs to reach agreement with clinical investigators to conduct the trial. The suitability of investigators and their institutional sites, typically hospitals, has to be evaluated, and the trial has to be set up at each site.

This Clinical Research Associate (CRA) Professional Certification Program describes the processes involved, focusing particularly on the role of a Clinical Research Associate (CRA) employed or contracted by the sponsor to monitor the trial.

The purpose of investigational site evaluation and set-up is to ensure that the site has access to the required patient population, has appropriately qualified, trained and committed staff with adequate time and facilities, and that it is fully prepared for the safe and successful conduct of the clinical trial. In this program we set out the criteria, procedures and documentation for evaluating a site and setting up a trial there.

The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and verified from source documents, and the conduct of the trial complies with the study protocol, Good Clinical Practice and regulatory requirements. In this program we describe how a Clinical Research Associate (CRA) monitors an ongoing trial to its conclusion. After a brief overview, the program consists of topics such as the following: closeout visit, essential documents, source document verification, CRF review, monitoring visit, fraud and scientific misconduct, and a key point summary at the end.

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 program 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 moves on to describe 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.

Assure employee understanding and importance of compliance with GCP standards, and how these apply to monitoring clinical studies:
This Clinical Trials Monitoring Professional Certification Program will review informed consent, GCP guidelines, and the important tasks involved in maintaining GCP compliance when monitoring clinical trials. This program may be used as a refresher for project managers and clinical research associates (CRAs), or taken by registered nurses (RNs), nursing assistants (CNA), licensed practical nurses (LPNs) or others, such as clinical research coordinators (CRCs) or investigators, seeking to move into a clinical trial monitoring or project management position.

The five (5) individual courses included in this program include: 1) ICH Good Clinical Practice (ICH-GCP); 2) Clinical Trials: Preparation and Design; 3) GCP: Clinical Trial Monitoring - Site Evaluation and Set Up; 4) GCP: Clinical Trial Monitoring - Documentation and Closure; and 5) GCP: Clinical Trial Monitoring - Preparing for an Audit or Inspection.

Students can take the final assessment any number of times, as needed, to achieve a passing grade. Once all course requirements have been satisfied, a professional certification has been achieved.

This Program Includes These 5 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

Individual Course w/Certificate of Completion:

Clinical Trials: Preparation and Design

Course ID: GCP002
Duration: 240 minutes (4 CPD Credits)
Price: Included

Individual Course w/Certificate of Completion:

Clinical Trial Monitoring: Site Evaluation and Set-up

Course ID: GCP004
Duration: 90 minutes (1.5 CPD Credits)
Price: Included

Individual Course w/Certificate of Completion:

Clinical Trial Monitoring: Documentation and Closure

Course ID: GCP005
Duration: 180 minutes (2 CPD Credits)
Price: Included

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

Additional Information:

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

Biopharma Institute's online training courses include immediate access after enrollment. Username, password, and instructions are emailed to the student directly following online enrollment into the program. Course takers may attempt the final assessment 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. Certificates are issued in an encrypted PDF format, and include a watermark, unique validation code, and QR verification barcode. Furthermore, a digital badge is also 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 accomplishments.

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.

Benefits of Being Certified from Biopharma Institute: Throughout our training students will be engaging in active learning using interactive eLearning modules validated by 3rd party organizations for relevancy, compliance, and regulatory content. Courses are developed by subject matter experts (SMEs) and instructional design professionals with the goal to promote the students' retaining of key knowledge. The programs further offer access to regulatory references, real-life case studies, and introduce other important information necessary to assist with learning. Since 2003, Biopharma Institute has been aiding both professionals and their corporate employers with fulfilling training requirements. Biopharma Institute's certifications are recognized by a wide spectrum of industries, regulators, and companies around the world. Furthermore, our training solutions are customizable to any organization's training needs. Today, Biopharma Institute offers over 300 courses training on clinical research, drug manufacturing (cGMP), regulatory affairs, validation systems, pharmacovigilance, good laboratory practice (GLP), and data integrity. We supply our training to clinical research, pharmaceutical, and medical device 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-scale and large-scale training requests, with the same goal in mind: To make this a good experience for everyone involved, from the students to those managing the group training.


Use our Search Form to Find What You're Looking For:

  

Benefits of Training with Biopharma Institute

Immediate access to courses:Username, password, instructions, and receipt of payment are immediately emailed upon online enrollment.
Self-paced, asynchronous eLearning:24/7 access to all course materials and assessments for 12 months.
Open enrollment:No prior course prerequisites or work experience required.
Expertise:Courses developed by subject matter experts (SMEs) in the area being taught.
Current and validated:Training is current with respect to regulations, procedures, and 3rd party validated and/or accredited.
Optimized for learning:Courses include voiceovers, easy navigation, reading materials, case studies, progress checks, and high-quality animations to increase retention of subject matter.
Secure and safe access:Encrypted website and LMS connections, firewall, and daily malware scans deliver optimal security and performance.
Flexible final assessments:Multiple-choice questions can be taken repeatedly until a passing score is achieved.
Direct access to certificates:Upon completion, certificates are immediately issued in an encrypted PDF format. Certificates include a watermark, unique validation code, and QR verification barcode.
Verification of training:Certificates are verifiable online using QR barcode or the unique ID code. Digital badges are additionally issued for all professional certification programs.
Training manager access:A proprietary portal offers access to download enrollment reports, training records, account balance, and more.
SCORM-compliant courses:Courses can be delivered directly to most corporate Learning Management Systems (LMS).
Purchase orders (POs):POs are accepted from all companies. Request an invoice when starting the procurement process.
Reimbursement:Some employers may reimburse their employees for training expenses. Check your company's policy.
Financial assistance:Payment plans are available to those who qualify. Alternatively, purchasing individual courses one at a time is also an option.
Career advancement:Professional certifications help demonstrate interest and dedication to career and job performance. They may be helpful for those seeking to grow their career or transitioning to a different position within an organization. Professional certifications are a great addition to a resume, offer talking points for the interview, and practical knowledge for performing duties.


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.

Name:
Company:
Phone:
Email:
 
Enter the number from the image above:
Comments:


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