How to Become Clinical Research Associate - AWARENESS SESSION
How to Become Clinical Research Associate - AWARENESS SESSION
Dear Candidate,
LEARNING's FOR JOB (ON-SITE CLASS ROOM / HOME-BASED)
We are conducting a FREE Awareness session to - How to become a Clinical Research Associate. Our programs provides most learning's required to meet job market supported with Real-Time Case Scenarios performed at Job. Students Our JOB ASSISTANCE PROGRAM helps candidates to find jobs that meets and will fit your education, skills and experiences. Enroll for Free into our Upcoming Program Awareness Session to know more and follow the instructions indicated below to get registration.
Topic : How to Become a Clinical Research Associate.
When : Sunday, 7th June 2015
Between : 11 am to 12.30 pm (Eastern Standard Time - EST)
Where : WebEx (Online) - 1.5 hr
This Awareness session provides insight to aspirant students, who wish to build their career pathways towards as Clinical Research Associate with various Pharmaceuticals. This session educates you to understand details on programs we offer and how we can help you to meet your career objectives.
This session includes learning's on, a) How to get started, b) who can qualify, c) what will be typical job duties, d) earnings you gain, e) On Training Support , f) What skills the industry looking for , g) Tools used, h) Post training Assistance Offered for resume marketing i) How to apply for Open Jobs j) Prospects and Pathways - Gaining Heights and many more..
INTERNSHIP OPPORTUNITIES IS PROVIDED FOR FRESH FROM SCHOOL STUDENTS WHO HAVE GRADUATED IN PAST 6 MONTHS (OR) GRADUATING IN 2015.
ABOUT QPDC
Established in 2000, Qtech-Sol Professional Development Center LLC (QPDC) is a Software Development and Professional Training Organization. It is a Private Vocational School and its Clinical Science Training Programs are approved by Department of Education and Department of Unemployment and Workforce Development, New Jersey, USA and listed on New Jersey Eligible Training Provider List since year 2011. We provide Job Oriented Programs and have helped many to find jobs after training.
QTECH IS AN EQUAL EMPLOYMENT OPPORTUNITY (EEO) PROVIDER.
WHO CAN QUALIFY:
Healthcare professionals (e.g. RN, PA, MD, PT.RPh, PharmD, Medical Technologist)
OR
Preferred degree in: Pharmacology/Toxicology, Pharmacy, Biotechnology, Industrial Pharmacy, Pharmaceutical Chemistry, Public Health/Medicine, Medicine, Nursing,
OR
Bachelor degree or higher in life science or Biological sciences
ENROLL FOR AWARENESS SESSION (FREE):
1) Go To : http://www.qtechelearncenter.com/Training/shopping_cart/
2) Select - AWARENESS PROGRAM ENROLLMENT
Select Workshop Code CRAW01 - Clinical Research Associate Workshop .
3) Add to cart and Fill-Out online Application and Accept the Terms.
4) Use PAY BY CHECK option for getting enrolled for this Session - No Payment Required.
5) We will email your confirmation for attendance into this session.
6) Enrolled Candidates will receive a WebEx invite to participation into this Awareness Session.
7) The WebEx Invite will contain instructions for setup and Login into this WebEx Class.
8) Headset will be required for discussions with the Subject Matter Expert (SME) during the WebEx session. Participants are requested to login to the WebEx session at least 5 minutes before the scheduled time.
Technical leanings: 45 days
Extensive knowledge pertaining to all phases of clinical trials in different therapeutic areas such as Oncology, Central Nervous system and cardiology in accordance with the applicable ICH, GCP, FDA and local regulation
Remarkable Knowledge in all areas of research including budgeting, GCP, IRB protocol submissions, on-going regulatory and IRB phases and IND safety reporting.
Demonstrated competencies in managing clinical trials data, formulating source documents and data collection charts and severe adverse event reporting.
Developed and authored Case report Forms (CRFs)
Created and Reviewed Informed consent forms
Detailed knowledge of study specific regulatory documents and able to update, and maintain study specific trial master files and system.
Knowledge of adverse events and serious adverse events reporting to the regulatory authority and FDA according to the GCP guidelines.
HANDS ON EXPERIENCE
Investigator Brochure and IND Application
Reviewed the contents of Investigator Brochure and Provided generalized brief and short explanation for each of the Content like What kind of information/Data included in that particular section.
Provided detailed explanation about the type of the information to be included in the each section of the IND application.
ICH-GCP Guidelines and FDA Regulations
Worked on situational GCP priority case scenarios from Investigational site and addressed the concerns
Institutional Review Board (IRB)
Reviewed Regulatory requirement criteria for IRB protocol review standards and provided missing information for regulatory requirements
Reviewed application for Human subject research and provided missing in each part of application
Protocol Design and Development
Provided description for each element covered in clinical trial protocol.
Reviewed the protocol for Phase II double blind placebo controlled clinical trial and provided outline for each section of the protocol
Clinical Trial Budget
Prepared a budget per patient upon reviewing a protocol for Phase II clinical trial.
CRF (Case Report Form) Design and Review
Identified and classified discrepancies upon reviewing CRFs.
Performed manual review of CRF and prepared quality control report.
Trial Master File
Reviewed artifacts from Trial Master Files and provided list and purpose of core/recommended documents pertaining to each zone of TMF
Informed Consent Form
Reviewed the Informed consent form and identified discrepancies
Provided missing entries in Informed consent form upon reviewing Phase II clinical trial protocol summary
Audit
Identified correct order as per standard IRB format for monitoring visit report upon reviewing Monitoring visit report
Reviewed the monitoring visit findings and determined the discrepancies
Investigator Meetings
Upon reviewing the Phase II Clinical trial protocol prepared a Power point presentation by detailing the Objectives, end points, inclusion exclusion criteria, visit schedule, drug accountability and other details covered in the protocol for investigator meeting.
Site Management and Initiation
Provided brief outline for the each section to be covered in the Site initiation checklist
Provided definition purpose of each artifact pertaining to Site Management Section in standard TMF (Trail Master File) reference model
Adverse event monitoring and reporting
Reviewed adverse events case scenarios from clinical trials and identified safety issues and reporting timelines
CAREER PATHWAYS:
Clinical Research Associate (In-House), Clinical Research Monitor, Trial Documentation Specialist, CRA - Trial master File Maintenance, CRA - Trial Documentation Specialist and CRF Data Validation.
Typical CRA / Research Jobs Titles hired by Pharmaceutical Companies:
CRA - Job Title - Clinical Research Associate (I, II , III).
CRM - Job Title - Research / Trial Monitor.
CRA - Job Title - Trial Documentation Specialist.
CTMS - Job Title - Clinical Trial Management Specialist.
TMF - Job Title - Trial Master File Specialist.
Coordinator - Job Title - Clinical Trial Coordinator (CTC).
Scientist - Job Title- Clinical Research Scientist (CRS).
Project Management - Job Title - Clinical Project Manager.
PROMOTION AND PROGRAM HIGHLIGHTS:
The Online Package and Individual Programs is backed with following features:
Presentations with Voice Over and Material per lesson.
Multiple Choice Objectives (MCQs).
Real-Time Job based Exercises with Scenarios per lesson.
Certificate Exam (Approved by Department of Education , State of NJ).
Access to Solutions for project and exercises.
Subject Matter Queries (Email Support)
Career Counseling and Guideline.
Post Assistance Training Program.
POST ASSISTANCE TRAINING PROGRAM:
Students who have completed training with us, will be qualified for this program. This program includes assistance, for the following.
Resume Preparation
Narrative Writing from resume for interview preparation.
Mock Interviews (Most expected questions and feedbacks for improvement)
Resume Submission and lead assistance for job application with prospective clients.
Client Interview preparation for possible interviews.
We provide CPT and H1 sponsorship for selected International Students.
For more details please email us.
Thank You
Estimated Salary: $20 to $28 per hour based on qualifications.
Dear Candidate,
LEARNING's FOR JOB (ON-SITE CLASS ROOM / HOME-BASED)
We are conducting a FREE Awareness session to - How to become a Clinical Research Associate. Our programs provides most learning's required to meet job market supported with Real-Time Case Scenarios performed at Job. Students Our JOB ASSISTANCE PROGRAM helps candidates to find jobs that meets and will fit your education, skills and experiences. Enroll for Free into our Upcoming Program Awareness Session to know more and follow the instructions indicated below to get registration.
Topic : How to Become a Clinical Research Associate.
When : Sunday, 7th June 2015
Between : 11 am to 12.30 pm (Eastern Standard Time - EST)
Where : WebEx (Online) - 1.5 hr
This Awareness session provides insight to aspirant students, who wish to build their career pathways towards as Clinical Research Associate with various Pharmaceuticals. This session educates you to understand details on programs we offer and how we can help you to meet your career objectives.
This session includes learning's on, a) How to get started, b) who can qualify, c) what will be typical job duties, d) earnings you gain, e) On Training Support , f) What skills the industry looking for , g) Tools used, h) Post training Assistance Offered for resume marketing i) How to apply for Open Jobs j) Prospects and Pathways - Gaining Heights and many more..
INTERNSHIP OPPORTUNITIES IS PROVIDED FOR FRESH FROM SCHOOL STUDENTS WHO HAVE GRADUATED IN PAST 6 MONTHS (OR) GRADUATING IN 2015.
ABOUT QPDC
Established in 2000, Qtech-Sol Professional Development Center LLC (QPDC) is a Software Development and Professional Training Organization. It is a Private Vocational School and its Clinical Science Training Programs are approved by Department of Education and Department of Unemployment and Workforce Development, New Jersey, USA and listed on New Jersey Eligible Training Provider List since year 2011. We provide Job Oriented Programs and have helped many to find jobs after training.
QTECH IS AN EQUAL EMPLOYMENT OPPORTUNITY (EEO) PROVIDER.
WHO CAN QUALIFY:
Healthcare professionals (e.g. RN, PA, MD, PT.RPh, PharmD, Medical Technologist)
OR
Preferred degree in: Pharmacology/Toxicology, Pharmacy, Biotechnology, Industrial Pharmacy, Pharmaceutical Chemistry, Public Health/Medicine, Medicine, Nursing,
OR
Bachelor degree or higher in life science or Biological sciences
ENROLL FOR AWARENESS SESSION (FREE):
1) Go To : http://www.qtechelearncenter.com/Training/shopping_cart/
2) Select - AWARENESS PROGRAM ENROLLMENT
Select Workshop Code CRAW01 - Clinical Research Associate Workshop .
3) Add to cart and Fill-Out online Application and Accept the Terms.
4) Use PAY BY CHECK option for getting enrolled for this Session - No Payment Required.
5) We will email your confirmation for attendance into this session.
6) Enrolled Candidates will receive a WebEx invite to participation into this Awareness Session.
7) The WebEx Invite will contain instructions for setup and Login into this WebEx Class.
8) Headset will be required for discussions with the Subject Matter Expert (SME) during the WebEx session. Participants are requested to login to the WebEx session at least 5 minutes before the scheduled time.
Technical leanings: 45 days
Extensive knowledge pertaining to all phases of clinical trials in different therapeutic areas such as Oncology, Central Nervous system and cardiology in accordance with the applicable ICH, GCP, FDA and local regulation
Remarkable Knowledge in all areas of research including budgeting, GCP, IRB protocol submissions, on-going regulatory and IRB phases and IND safety reporting.
Demonstrated competencies in managing clinical trials data, formulating source documents and data collection charts and severe adverse event reporting.
Developed and authored Case report Forms (CRFs)
Created and Reviewed Informed consent forms
Detailed knowledge of study specific regulatory documents and able to update, and maintain study specific trial master files and system.
Knowledge of adverse events and serious adverse events reporting to the regulatory authority and FDA according to the GCP guidelines.
HANDS ON EXPERIENCE
Investigator Brochure and IND Application
Reviewed the contents of Investigator Brochure and Provided generalized brief and short explanation for each of the Content like What kind of information/Data included in that particular section.
Provided detailed explanation about the type of the information to be included in the each section of the IND application.
ICH-GCP Guidelines and FDA Regulations
Worked on situational GCP priority case scenarios from Investigational site and addressed the concerns
Institutional Review Board (IRB)
Reviewed Regulatory requirement criteria for IRB protocol review standards and provided missing information for regulatory requirements
Reviewed application for Human subject research and provided missing in each part of application
Protocol Design and Development
Provided description for each element covered in clinical trial protocol.
Reviewed the protocol for Phase II double blind placebo controlled clinical trial and provided outline for each section of the protocol
Clinical Trial Budget
Prepared a budget per patient upon reviewing a protocol for Phase II clinical trial.
CRF (Case Report Form) Design and Review
Identified and classified discrepancies upon reviewing CRFs.
Performed manual review of CRF and prepared quality control report.
Trial Master File
Reviewed artifacts from Trial Master Files and provided list and purpose of core/recommended documents pertaining to each zone of TMF
Informed Consent Form
Reviewed the Informed consent form and identified discrepancies
Provided missing entries in Informed consent form upon reviewing Phase II clinical trial protocol summary
Audit
Identified correct order as per standard IRB format for monitoring visit report upon reviewing Monitoring visit report
Reviewed the monitoring visit findings and determined the discrepancies
Investigator Meetings
Upon reviewing the Phase II Clinical trial protocol prepared a Power point presentation by detailing the Objectives, end points, inclusion exclusion criteria, visit schedule, drug accountability and other details covered in the protocol for investigator meeting.
Site Management and Initiation
Provided brief outline for the each section to be covered in the Site initiation checklist
Provided definition purpose of each artifact pertaining to Site Management Section in standard TMF (Trail Master File) reference model
Adverse event monitoring and reporting
Reviewed adverse events case scenarios from clinical trials and identified safety issues and reporting timelines
CAREER PATHWAYS:
Clinical Research Associate (In-House), Clinical Research Monitor, Trial Documentation Specialist, CRA - Trial master File Maintenance, CRA - Trial Documentation Specialist and CRF Data Validation.
Typical CRA / Research Jobs Titles hired by Pharmaceutical Companies:
CRA - Job Title - Clinical Research Associate (I, II , III).
CRM - Job Title - Research / Trial Monitor.
CRA - Job Title - Trial Documentation Specialist.
CTMS - Job Title - Clinical Trial Management Specialist.
TMF - Job Title - Trial Master File Specialist.
Coordinator - Job Title - Clinical Trial Coordinator (CTC).
Scientist - Job Title- Clinical Research Scientist (CRS).
Project Management - Job Title - Clinical Project Manager.
PROMOTION AND PROGRAM HIGHLIGHTS:
The Online Package and Individual Programs is backed with following features:
Presentations with Voice Over and Material per lesson.
Multiple Choice Objectives (MCQs).
Real-Time Job based Exercises with Scenarios per lesson.
Certificate Exam (Approved by Department of Education , State of NJ).
Access to Solutions for project and exercises.
Subject Matter Queries (Email Support)
Career Counseling and Guideline.
Post Assistance Training Program.
POST ASSISTANCE TRAINING PROGRAM:
Students who have completed training with us, will be qualified for this program. This program includes assistance, for the following.
Resume Preparation
Narrative Writing from resume for interview preparation.
Mock Interviews (Most expected questions and feedbacks for improvement)
Resume Submission and lead assistance for job application with prospective clients.
Client Interview preparation for possible interviews.
We provide CPT and H1 sponsorship for selected International Students.
For more details please email us.
Thank You
Estimated Salary: $20 to $28 per hour based on qualifications.
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