Clin Infotech

Clinical Research Associate Training – CRA Training Program

  • Advance your Career through Clinical Research Associate Training Program (CRA Training Program) through Clinical Research Assocaite course Curriculum enveloping fundamental themes like Clinical Trials, Drug Development Process and Clinical Trial Management System, Protocol Guidelines Etc.., .Our Job Oriented  Interactive-CRA Training program for Clinical Research Professionals are intended for people with or without earlier clinical trial experience, make to be successfully can get job as a Principal Investigator (PI), Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), Clinical Data Coordinator or Clinical Data Manager (CDM). The CRA Training Program at Clin Infotech not only make to get job but we make to gain complete Practical Knowledge in the Clinical Trial Management System.
  • This Clinical Research Associate course includes classroom sessions with industry experts and Clinical Research professionals from the field of Clinical Trials, gives live Session about the Clinical Trial process, CRF Designing,Process,Clinical Trial Management, Clinical Trial Phases, process involved in the Clinical trial Phases and the roles and responsibilities of clinical research Associate.Experts carefully design this course with methods proven to give results and give the students amazing learning experience.The Candidates with Pharmacy, Life Sciences, BDS Dental, Medical and Nursing Graduates can Participate in CRA Training and Placement Program. They can also join in CRA Online training program or CRA Class room training program.

What Is Clinical Research Associate? Who Is Clinical Research Associate?

As a clinical research associate (CRA), you’ll run clinical trials to test drugs for their effectiveness, risks and benefits to ensure that they are safe to allow on to the market. They will work on new and existing drugs and will usually be employed by either a pharmaceutical company or a contract research organisation (CRO) with the Clinical Research Associate Skills which works on behalf of pharmaceutical companies. The professionals who perform these activities are said to be a Clinical Research Associate/ Clinical Researcher professional. Clinical Research is the most high-in-demand profession.

CRA Course Curriculum:

  • Module 1: Drug Development Process, Good Clinical Practice (GCP), and Clinical Research Team Roles and Responsibilities
  • Module 2: IRB, Clinical Study Protocol Elements and Amendments
  • Module 3: Informed Consent
  • Module 4: Investigational Product Accountability
  • Module 5: Safety Definitions and Reporting Requirements
  • Module 6: Source Document Verification
  • Module 7: Monitoring the Study
  • Module 8 and Module 9: Monitoring Visit Reports and Contact Reports
  • Module 10: Regulatory Compliance and Quality Assurance: Audits and Inspections

Why One Should Take The Clinical Research Associate Course?

Is Clinicla Research Associate certification being worth pursuing as a career?

The answer is a big YES for myriad reasons.The Clinical Trials for Different Drugs has been Increasing because of the growing Clinical Trials the demand for the Clinical research Professionals has been increasing who has completed Clinical Research Associate training and placement Program with Certification. The Clinical Research domains is creating tons of Clinical Trial data and the demand for the Clinical Research professionals who can evaluate and extract meaningful insights is increasing and creating millions of clinical research jobs.

  • 1.4 Lakh Clinical research Associate Job Opportunities are available
  • The world will notice a deficit of 2.3 Lakh Clincal Research professionals by 2021
  • The Demand for Clincial Research professionals has increased by 417% in the year 2018, in India, as per the Talent Supply Index

What does a Clinical Researh Associate do?

Clinical Research Associate Job Description:

  • As a Clinical Research Associate (CRA) you  will be responsible for setting up, coordinating and supervising clinical studies (trials) with medicines, medical nutrition or medical devices. You will be  doing the  selection, initiation, monitoring and close-out visits at the participating clinical trial centers. During a monitor visit you will verify various (patient) data included in the eCRF (electronic Case Report Form) by the physician-researcher (investigator, medical specialist) or research nurse. This process, called source data verification (source being the electronic patient file, EPD) checks whether the study has been carried out in accordance with applicable laws and regulations (Good Clinical Practice, ICH-GCP) and company Standard Operating Procedures (SOP’s).
  • develop and write trial protocols (outlining purpose and methodology.
  • present trial protocols to a steering committee
  • design data collection forms, known as case report forms (CRFs)

  • coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects.
  • Manage regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs
  • identify and assess the suitability of facilities to use as the clinical trial site
  • identify/select an investigator who will be responsible for conducting the trial at the trial site
  • liaise with doctors, consultants or investigators on conducting the trial
  • set up the trial sites – ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product (IMP)
  • train the site staff to trial-specific industry standards
  • monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis
  • verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
  • collect completed CRFs from hospitals and general practices
  • write visit reports and file and collate trial documentation and reports
  • ensure all unused trial supplies are accounted for
  • close down trial sites on completion of the trial
  • discuss results with a medical statistician, who writes technical trial reports
  • archive study documentation and correspondence
  • prepare final reports and occasionally manuscripts for publication.
  • The objective of a clinical drug study is to demonstrate that the investigational product has a certain desired effect for the disease or disorder for which it is being developed, whether it is safe, and that all adverse reactions / adverse events have been reported according to the study protocol and have been rated on seriousness, severity, and causality with the investigational product. Clinical studies are classified according to their phase in development:
  • Phase I – In this phase the active substance is to be tested on a small group of healthy subjects. The central question then is whether the substance is safe and with which dose development is to be continued;
  • Phase II – In this phase the effect of the drug (or investigational product) on patients (who have the disease or disorder for which the medicine is being developed) is investigated. Is it effective and safe in the desired dose? The number of patients in this phase is usually a few tens to some hundreds;
  • Phase III – In this phase, the research product is tested on (future indication) patients, usually in comparison to placebo, often on top of usual care. The objective is to gain more insight into the effectiveness (efficacy) and side effects (safety). The number of patients in this phase is a few hundred to thousands. With larger numbers you can measure and test more accurately, with less biass and better clinical significance. Sometimes side effects come up that did not come up before;
  • Phase IV – This phase of development takes place after the registration of the investigational product. The purpose of studies in this phase is to investigate the use of the research product in daily practice and to obtain additional safety information, insight into the cost-effectiveness (efficiency), often in connection with access to the market, or reimbursement by insurers. Also, in this phase the drug is often compared with competing drugs, or it is checked whether the drug is suitable for other indications than those for which registered in first instance.

Job Opportunities With Clinical Research Associate Certification?

Clinical Trial Assistant (CTA) Clinical Research Associate
Clinical Research Coordinator Clinical Research Manager
Drug SafetyAssociate Clinical Trail Writer
Clinical Data Analyst Clinical Trial Writer
Senior CRA Medical Writer
Medical & Regulatory Officer Manager – Safety / Patients
Data Analyst –  Pharmacovigilance Regulatory Affairs Executive
Clinical Data Analyst Clinical Trial Auditor
Project Manager Clinical Data Analyst
Clinical Research Analyst Clinical Investigator
Clinical Trial Coordinator CRA Analyst
Clinical Data Programmer Clinical Data Base Designer
Clinical Trial Analyst Clinical Data Scientist
Scientific Writer Pharmacovigilance Scientist
Clinical Analyst Regulatory Affairs Associate

Clinical Research Associate Salary?

  • Clinical research Associate Salary are in the region of 2.4 Lakhs to 4.5 Lakhs. It’s likely these posts will require some experience in a related area along with the CRA certification Program from Reputed CRA training institutes in Hyderabad.

Clinical Research Associate Companies:

IQVIA,Covance,Parexel,Asiatic clinical Research,Astron research,BioAxis,Bioclinica,Axis Clinical,Croissance,Dubar Research foundation,eresearch technologies,global clinical Trials,GVK Biosciences,Kemwell Biopharma,labcorp,Lambda Therapeutics,Makro care,Navitas LifeSciences,Novotech,PPD,Sai Life Sciences,Spectrum Clinical Research,Strides Pharma Research,symphony,syneos Health Care,Syngene,Techobserver,Vedic  Life sciences Etc.

Interview Preparation Sessions

Participants who have completed the Clinical Research Associate course training will be put under our Placement Incubation Program. As part of this program, participants will undergo a thorough CRA interview preparation process. A huge repository of Clinical Research Interview questions with answers will be provided for the participants to prepare after CRA online Certification. A dedicated Clinical Research Associate Trainee Expert (SME) will help in resume building, conduct mock interviews and evaluate each participant’s knowledge, expertise and provide feedback. Clinical Research Associate Resume Samples will be given and the participant should Update With Clinical Research Associate Skills. Our SMEs will do the necessary handholding on Clinical Research Associate interview preparation process till the time the participant is placed in Clinical Research Companies in Hyderabad,Pune Mumbai and Bangalore etc. Guidance is also provided on Linkedin profile building and tricks of the trade to improve the marketability of the resume. – Clin Infotech Management.

Clinical Research Associate Course Qualification?

  • Clinical Research Associates with less than two years of experience – in-house or field-based
  • Those currently working in the industry in a different role and seeking to change roles
  • The course is also ideal for “on-boarding” of individual new hires or entire teams (individual registrations required).

Eligibility

Any Graduate/ B.tech/ B.Sc. in Microbiology/ Life Sciences/ Botany/ Zoology/ Food Science/ Food Technology/ BE/ B.Pharma/ MBBS/ BDS/ BHS/ BUMS/ BAMS or any other discipline. Diploma holders are eligible for our Clinical Research Associate Certifcation and CRA training and Placement Program

Registration

  • The Candidates Can Register at Clin Infotech through our Register Link or contact our Management Team. They can Register for Clinical Research Associate Online program or class room program. The CRA Online program will be provided with the LMS Access.The registration dates for Clinical Research Assocaite Training program. The Effective E-learning tools incorporated into the design of the webpage make the CRA course lectures, online live classes and study material easily accessible.

Why Clin Infotech The Clinical Research Associate Training Institute In Hyderabad?

Clin Infotech offers the best CRA Certification online Program along with classroom and self-paced e-learning certification courses. The complete CRA course details can be found in our course agenda on this page. We will provide the CRA Classes with Live Scenarios with the CRA trainer to make them understand the Clinical research Associate Roles and Responsibilities and that’s the reason Clin Infotech consider as the best CRA Institute in Hyderabad.

Clinical Research Associate Certification Process:

  • All learning Participants will be led Assessment & CRA Online Certification Exam.
  • All the participants are expected to appear for CRA online assessment
  • After successful completion the participants will be certified as professional in Clinical Research Associate by Clin Infotech.

Placement Assistance & Corporate Relations

In recent months the Institute has witnessed more and more participation from professionals working with global pharmaceutical, healthcare and food giants like Dr. Reddy’s Laboratories, Aurobindo Pharma, Glenmark Generics, Cipla, Wockhardt, Pfizer, Abbott, Medtronic, Foster Corporation, IPCA Laboratories, Calyx, Mother Dairy, Bliss GVS Pharma, Al Rawabi, Almarai, Green Pastures, SeQuent, PepsiCo India, Mankind, Beryl Drugs, Allergy Therapeutics, CFTRI, Ciron, Sun Pharmaceutical, Novartis, GlaxoSmithKline, Ranbaxy , Biocon etc.

 Clin Infotech Placement Resource Division actively recommends our students and training participants for various job requirements and specialized roles to Human Resource, Talent Acquisition as well as the heads of various departments in Pharmaceutical, Healthcare and Food industries on regular basis.

As a clinical research associate (CRA), you’ll run clinical trials to test drugs for their effectiveness, risks and benefits to ensure that they are safe to allow on to the market. They will work on new and existing drugs and will usually be employed by either a pharmaceutical company or a contract research organisation (CRO) with the Clinical Research Associate Skills which works on behalf of pharmaceutical companies. The professionals who perform these activities are said to be a Clinical Research Associate/ Clinical Researcher professional. Clinical Research is the most high-in-demand profession.

 The Salary will be ranging from 2.4 Lakhs to 6.5 Lakhs Per anum.

 

 

 

 

 

  • Ans: As a Clinical Research Associate (CRA) you  will be responsible for setting up, coordinating and supervising clinical studies (trials) with medicines, medical nutrition or medical devices. You will be  doing the  selection, initiation, monitoring and close-out visits at the participating clinical trial centers. During a monitor visit you will verify various (patient) data included in the eCRF (electronic Case Report Form) by the physician-researcher (investigator, medical specialist) or research nurse. This process, called source data verification (source being the electronic patient file, EPD) checks whether the study has been carried out in accordance with applicable laws and regulations (Good Clinical Practice, ICH-GCP) and company Standard Operating Procedures (SOP’s).

Clin Infotech offering Clinical Research Assoicate Training program and class room training. Who ever completed the CRA online certification has to undergo the assessment exam and should clear the exam to gain the clinical research associate certification.

Clin Infotech offering Best CRA course Or Clinical Research Assoicate Training program both Online and class room training With the Placement Offers Who ever completed the CRA certification course has to undergo the assessment exam and should clear the exam to gain the clinical research associate certification.