New Jersey 732.770.4100

 Clinical Research Workshops

Clinical Trial Protocol Development

Workshop Topic   Clinical Trial Protocol Development
Domain Clinical Research Associate Workshop
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level as a Senior Clinical Research Associate
What Student will learn/gain Learn about various expertise and knowledge needed to develop a Protocol
for a Clinical Study and to plan out various aspects like dosage and
administration, ICF Process, Feasibility assessment etc towards testing the hypothesis.
Career Pathway Clinical Project Manager/ In House Site Manager
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of:
Clinical Project Manager,In-house Site Mangers,Clinical Research Managers
in the field of Clinical Operations in Pharmaceutical, Biotechnological
Companies or Clinical Research Organization
Prerequisite Associate Degree, BS/MS in Biology,Pharmacology
BS/MS in Public Health, RN, MD or have prior 3-5 years of experience
in the field of Clinical Research.

Informed Consent Form (ICF) Development

Workshop Topic   Informed Consent Form (ICF) Development
Domain Clinical Research Associate Workshop
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level as a Senior Clinical Research Associate
What Student will learn/gain Learn about various elements to be covered to develop an
Informed Consent Form for a Clinical Study and the Regulations
involved.
Career Pathway Clinical Project Manager/ In House Site Manager
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of:
Clinical Project Manager,In-house Site Mangers,Clinical Research Managers
in the field of Clinical Operations in Pharmaceutical, Biotechnological
Companies or Clinical Research Organization
Prerequisite Associate Degree, BS/MS in Biology,Pharmacology
BS/MS in Public Health, RN, MD or have prior 3-5 years of experience
in the field of Clinical Research.

Subject Recruitment and Regulatory Ethics

Workshop Topic   Subject Recruitment and Regulatory Ethics
Domain Clinical Research Associate Workshop
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level as a
Jr Clinical Research Associate.
What Student will learn/gain Learn about the process of recruiting subjects for a Clinical Study, estimating
the potential for a site,factors influencing subject recruitment and the Regulatory Ethics to be followed.
Career Pathway Clinical Research Coordinator/ Regional Monitor
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of: Clinical Research Cooridnator,
Site coordinator, Field Monitors, Regional Monitors, Regulatory Cooridnators etc
in the field of Clincial Operations in Pharmaceutical, Biotechnogical Companies or Clinical Research Organization.
Prerequisite Associate Degree, BS/MS in Biology, Pharmacology, BS/MS in Public Health,
RN, MD or have prior 0-2 years experience in the field of Clinical Research

Case Report Form (CRF) Designing and Data Capture

Workshop Topic   Case Report Form (CRF) Designing and Data Capture
Domain Clinical Research Associate Workshop
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level as a Sr Clinical Research Associate.
What Student will learn/gain Learn about various expertise and knowledge needed to develop a Case Report form
for recording relevant Clinical Data as per Clinical Protocol for a Clinical Study
Career Pathway Clinical Project Manager/In house Site Manager
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of: Clinical Project Manager,
In-house Site Mangers, Clinical Research Managers in the field of Clincial Operations in Pharmaceutical, Biotechnogical Companies or Clinical Research Organization.
Prerequisite Associate Degree, BS/MS in Biology, Pharmacology, BS/MS in Public Health,
RN, MD or have prior 3-5 years experience in the field of Clinical Research

Selecting Investigator and Sites for Trial Conduction

Workshop Topic   Selecting Investigator and Sites for Trial Conduction
Domain Clinical Research Associate Workshop
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level as a
Clinical Research Associate.
What Student will learn/gain Learn about the Selection process for a Investigator Site and Investigator to
conduct a Clinical Trial in compliance with Regulatory guidelines.
Career Pathway Inhouse Clinical Research Associate/Clinical Study Associate
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of: CRA II/III,
Inhouse Clinical Research Associate, Site Manager, Project Lead, Local study Leader,
Clinical Study Associate in the field of Clincial Operations in Pharmaceutical, Biotechnogical Companies or Clinical Research Organization.
Prerequisite Associate Degree, BS/MS in Biology, Pharmacology, BS/MS in Public Health,
RN, MD or have prior 2-3 years experience in the field of Clinical Research

Clinical Trial Site Monitoring and Types of Visits

Workshop Topic   Clinical Trial Site Monitoring and Types of Visits
Domain Clinical Research Associate Workshop
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level as a Clinical Research Monitor
What Student will learn/gain Learn about various expertise and knowledge needed to perform site
Monitoring and different types of site visit.This workshop will provide detail understanding regarding essential aspects of site Monitoring
Career Pathway Inhouse Clinical Research Associate/Clinical Study Associate
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of: Clinical Research Monitor,
Site Manager, Clinical Research Manager,field Monitor in the field of Clinical Operations in Pharmaceutical, Biotechnogical Companies or Clinical Research Organization.
Prerequisite Associate Degree, BS/MS in Biology, Pharmacology, BS/MS in Public Health,
RN, MD or have prior 1-3 years experience in the field of Clinical Research/Monitoring

Clinical Trial Master File (TMF)

Workshop Topic   Clinical Trial Master File (TMF)
Domain Clinical Research Associate Workshop
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level as a Trial Master File Manager
What Student will learn/gain Recognize the importance of TMF and implementation of strategies for
effective record keeping/filling of required documents; Effective management of the Trial Master File
Career Pathway Inhouse Clinical Research Associate/Clinical Study Associate/Clinical Trial Coordinator
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of: Clinical Study Associate,
Clinical Trial coordinator, Trial Master File Manager in the field of Clinical Operations in Pharmaceutical, Biotechnogical Companies.
Prerequisite Associate Degree, BS/MS in Biology, Pharmacology, BS/MS in Public Health,
RN, Sponsor and CRO personnel involved in set up, maintenance, and auditing
of the Trial Master File for sponsors or have prior 2-3 years experience in the field of Clinical Research

Clinical Trial Management system (CTMS)

Workshop Topic   Clinical Trial Management system (CTMS)
Domain Clinical Research Associate Workshop
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level in Clinical Trial Management system.
What Student will learn/gain Learn about basic framework of a Clinical Trial Management System
and understanding of its role in managing a Clinical Trial
Career Pathway Inhouse Clinical Research Associate/Clinical Study Associate/Clinical Trial Coordinator/CTMS assistant
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of: Clinical Study Associate,
Clinical Trial coordinator, Clinical Trial Management Assistant in the field of Clinical Operations in Pharmaceutical, Biotechnogical Companies .
Prerequisite Associate Degree, BS/MS in Biology, Pharmacology, BS/MS in Public Health, RN,
Sponsor personnel involved in the field of Clinical Research, ideal external training opportunity for those new to the Clinical Research working as a CRA or CRC and those who wish to have a career transition into pharmaceutical domain

Clinical Trial Data Base Lock (DBL)

Workshop Topic   Clinical Trial Data Base Lock (DBL)
Domain Clinical Research Associate Workshop
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level as expert for Data Base Lock
What Student will learn/gain Recognize the importance of Database lock and implementation
of strategies for effective Data Management skills in Clinical Trial
Career Pathway Sr Clinical Research Associate/Clinical Data Manage/Associate Data Manager
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of: Clinical Data Manager,
Sr Clinical Research Associate in the field of Clinical Operations in Pharmaceutical, Data Management Companies .
Prerequisite Associate Degree, BS/MS in Biology, Pharmacology, BS/MS in Public Health,
RN, Sponsor and CRO personnel involved in Clinical Data Management
for sponsors or have prior 1-3 years experience in the field of Data Management for Clinical Research

Clinical Trial Audit (Inhouse and Onsite)

Workshop Topic   Clinical Trial Audit (Inhouse and Onsite)
Domain Clinical Research Associate Workshop
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level to understand and manage Audit
What Student will learn/gain This workshop provides detail knowledge pertaining to types of Audit,
reasons of Audit and procedure of Audit.
Career Pathway Sr Clinical Research Associate/ Clinical Research Auditor
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are willing to pursue the role of: Sr CRA,
Clinical Research Auditor or who wants to have Transition in QA department as Auditor in the field of Clinical Operations in Pharmaceutical, Biotechnogical Companies .
Prerequisite Associate Degree, BS/MS in Biology, Pharmacology, BS/MS in Public Health, RN,
Sponsor and CRO personnel involved in Clinical Research and have prior 2-5 years experience in managing clinical Trial and aware of Clinical Research conduct

Role of Clinical Research Associate

Workshop Topic   Role of Clinical Research Associate
Domain Clinical Research Associate Workshop
Objectives of this Workshop This course provides practical tips, hands on exercises, case studies,
assignments and presentations to build expertise and confidence level as a Senior Clinical Research Associate
What Student will learn/gain Learn about various expertise and knowledge needed to perform the Role of Clinical Research Associate for conducting Trials at Pharmaceuticals. Learning's for Job. You will learn the step by step process, a CRA will follow to perform all the 3 levels of job duties (Initiation, Montoring and Close Out) from start to finish.
Career Pathway Clinical Research Associate / Research Analyst (In-House)
Delivery Methodology Webex (Online)
No of Classes 2 (2 Hours/Day)
Online Material Access 3 Days Access to Material for Workshop Delivery
(Presentation, Exercises, MCQs and Task Exercise for submission)
Schedule Times Batches with flexible schedules(per Time Zone)
Who Can Attend Individuals who are looking forward to work as CRA : Clinical Research Associate, Clinical Project Manager,In-house Site Mangers,Clinical Research Managers in the field of Clinical Operations in Pharmaceutical, Biotechnological Companies or Clinical Research Organization
Prerequisite Associate Degree, BS/MS in Biology,Pharmacology BS/MS in Public Health, RN, MD or have prior 3-5 years of experience in the field of Clinical Research.


© 2017   |   Qtech-Sol Professional Development Center LLC.   |   All rights reserved