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Qtech-Sol Professional Development Center

Clinical Research Project Management and Trial Monitoring (CRPM)

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CRPM

Clinical Research Project Management and Trial Monitoring (CRPM)

3 Students Enrolled
8 Weeks/200 Hours

The course provides a thorough Foundation, Advanced and Project Management related concepts focusing clinical trials, drug development, Study design, Project Management, and Monitoring concepts of Clinical Sciences in reference to roles and responsibilities performed by Clinical Research Associate. The concepts include a protocol development, assessment and reporting of adverse events and explains GCP-ICH guidelines along with other necessary regulatory information. The course emphasizes on understanding of the science and the expectations of initiating, conducting, monitoring, and managing clinical trial related work. This training will develop the technical skills and knowledge pertaining to roles and responsibilities of CRA – In House. Students will get exposure to real time practices pertaining to Case Report forms (CRFs), Trial Master File (TMF), Clinical Trial Protocol, Clinical Trial Budget, and Audit. The course curriculum is designed to give an edge to obtain job opportunity in clinical research field.

Our Programs are delivered in 3 Different ways for convenience of student:
• Self-Paced Individual Program (SIP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions
• Self-Paced Blended Program (SBP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions. Support thru Email and Phone for queries. Student participates in 7 days Post Training Assistance program for Resume preperation
• Self-Paced Package Program (SPP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions. Support thru Email and Phone for queries. Student participates in 15 days Post Training Assistance program for Resume preperation, Interview Narratives and Mock session. Obtains Job refferal and leads for application with clients and vendors

Lessons: 26 Lessons Duration: 08 Weeks / 200 Hours Language: English
Admission Requirements:

Recommended: An Associate or Bachelor’s degree in Medicine, Nursing, Pharmacy, Public health Biology, Biochemistry, Biotechnology, Chemistry, Clinical Research, Biomedical engineering, Public health, Pharmacology, or toxicology, Medical Device & Technology, Psychology, Sociology and Healthcare Administration.

Scholarship:

Institutional Scholarship / Promotion is available for selected on tuition. We review your education background, certifications, and prior experiences (if applicable), to evaluate your eligibility. Qualified student will be provided with the promo code for scholarship on Tuition.
Please Email your resume to Human Resources hrs@qtech-solutions.com to check on your eligibility. We will contact you. Q-tech’s objective is to provide you the right career pathway and advancement required to meet your career goals.

Learning Outcomes:

The Benefit Student Gains

1) Upgrading the Knowledge required.
2) Better Resume Placement for promising jobs.
3) Low Investment, high learnings
4) Learn from Anywhere, Anytime at your pace.
5) Job and Title Based Tasks as followed and Practiced in industry
6) Applying Concept into Real-time (Policies, governance and tools)
7) Work on Role Based Tasks followed and Practiced in industry
8) Mocks and Narratives for Client Discussions
9) Readiness to work with limited support

Career Pathways

Our objective is to help Experienced Clinical Research Professionals to meet the following career pathways. Typical Clinical Research Project Management Job Titles the candidates can apply after this training program are:

PROJECT MANAGEMENT – CLINICAL RESEARCH JOB TITLES
Clinical Program ManagerManager of Office Sponsored Programs
Clinical Data Project ManagerResearch Business Operations Analyst
Clinical Research ManagerClinical Trial Project Manager
Manager, Integrated Clinical TrialsClinical Study Manager
  • Curriculum Overview

    A Clinical Research Project / Study Manager (CRM) is responsible for the monitoring, data collection and analysis, and reporting of clinical trials performed and follow Ethical practices, ICH, GCP and Clinical Safety guidelines per U.S. and international markets.
    The CRPM training emphasizes on practical aspects as presentations in the reference to role performed by CRM into industry.
    Our program is approachable which provides in-depth knowledge and practical exposure to roles and responsibilities performed by Clinical Research Project Manager / Study Manager. It gives insight into topics.

    CLINICAL RESEARCH PROJECT MANAGEMENT AND TRIAL MONITORING

    LESSONS :ADVANCED TOPICS

    1);  Clinical Trial Budget

    2);  Investigator Selection

    3);  Pre-Study Visit

    4);  Protocol

    5);  Informed Consent Preparation

    6);  Investigational New Drug (IND) Application

    7);  Institutional Review Board (IRB) Regulatory Correspondence

    8);  Case Report Form (CRF)

    9);  Site Monitoring

    10)  Co-Monitoring Visits

    11)  Study Initiation Visit

    12)  Clinical Trial Management Systems (CTMS) Tracking Recording

    13)  Trial Master File

    14)  Database Lock

    15)  Audit

    PROJECT MANAGEMENT / CASES

    16) Risk Based Monitoring (RBM)

    17) FDA Audit process for Clinical Research

    18) Clinical Trial Project Management (CTPM) and Time-lines

    19) Development of Monitoring Plan

    20) Protocol Deviation/Violation Management

    21) Trial Master File and QC Management

    22) Clinical Data Reconciliation and Archiving

    23) Management and Reconciliation of Investigational Product

    24) Advanced Clinical Research Management Modules 1 thru 4

    25) Planning and Conducting Global Clinical Trials

    26) Management of a Successful Clinical Research Site - Part A & B

    EXCERCISES

    1.;  Clinical Trial Budget

    2.;  Investigator Selection

    3.;  Pre-study site visit

    4.;  Protocol

    5.;  Informed Consent Form

    6.;  IND Application

    7.;  IRB Regulatory Correspondence

    8.;  Clinical Trial Budget

    9.;  Investigator Selection

    10.  Pre-study site visit

    11.  Protocol

    12.  CTMS Track Recording

    13.  Trial Master File

    14.  Database Lock

    15.  Audit

Instructor

qtech-admin

5.00 average based on 3 ratings

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Reviews

  • I am very thankful to Q tech learning center team for providing training in Clinical Research Project Management (CRPM), as it will be helpful for me to gain experience in real time.

    Maureen D

    Paul A

  • The training helped me enhance my skills. The training was given in a very well planned, organized and professional manner.

    Gamal

    Neepa Y

  • The program was extremely helpful and the instructions were very knowledgeable. Thank you very much.

    Sangeetha

    Lily W

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