Clinical Trial Manager

Advanced Clinical Research Project Manager Certification (ACRPMC)

Advanced Clinical Research Manager Training that is Industry-Recognized I 250 Hours I On-Demand I 17.5 CME I 100+ Modules I GCP E6R2 Complaint I Triple-Accredited I Instant Enrollment I 2+ Week Certification
ACRP PM

Clinical Research Project Manager Training

Advanced Clinical Research Associate Certification (ACRAC)

  • 1

    Introduction

    • Accreditation Statement

    • CME Handout

    • Common Terminology Used In Clinical Research - Reference Glossary

    • Commonly Used Abbreviations and Terms in Clinical Research

  • 2

    ICH GCP

  • 3

    Fundamentals of Project Management

    • Project Management Fundamentals

    • PMBOK Summary - Mandatoryl Project Management Review

    • Clinical Trial Project Management

    • Importance of Project Management

  • 4

    Roles and Relationships in Clinical Trials

    • Role of a Project Sponsor

    • ICH GCP E6 Section 5 - Sponsor/CRO Responsibilities

    • Institutional Review Board/Ethics Committee (IRB/EC) (Requirements, sIRB, Application, Exemptions, Expedited Review, Continuation, and Reporting)

    • Data Safety Monitoring board- DSMB

    • Stakeholders in Clinical Trials (Sponsor, Project Manager, IRB, PI, CRA, CRC, Site Staff, Data Team/DSMB, Patients)

    • Contract Research Organizations (Delegation, Responsibilities, Management )

    • ICH GCP E6 Sections 2-4 Principles, IRB, & Investigator Roles

    • ICH GCP E6 Section 4 - Reporting Responsibilities of the Investigators

  • 5

    Skills of a Project Manager

    • Essential skills of a Project Manager

    • Technical skills for Project Management

    • Project Team

    • Managing a Project Team

  • 6

    Project Management Documents

    • Project Management Documents

  • 7

    Regulatory Documents

    • Regulatory Documents in Clinical Trials

    • Delegation of Authority Log – DOAL

    • Investigators Brochure (IB)

  • 9

    New Drug Application

    • The Investigational New Drug (IND) & New Drug Application (NDA) Process

    • Investigator Initiated Multi-Center Trials

    • IND and IDE AE Reporting

    • Safety Reporting Requirements for Sponsor Investigators of An IND

  • 10

    Problem Solving in Project Management

    • Problem Solving as a Project Manager

    • Project Failures and Statistics

    • Project Reporting Styles

    • Avoiding Project Failure

  • 11

    Budgeting for Clinical Trials and Projects

    • Project Budgeting

    • Payments and Budgeting for Investigators and Site

    • Advertisement Aid in Subject Recruitment and Retention

  • 12

    Clinical Trial Design

    • Advanced Designs of Clinical Trials

    • Advanced Review of Phases of Clinical Trials (Preclinical & Phase 0-4)

    • Randomized Controlled Trials (Randomization, Allocation Concealment, Validity, Blinding, Controls, Outcomes, Fidelity)

    • Blinding and Unblinding in Clinical Trials

    • The Clinical Trial Protocol - Advanced Mastery Review

    • Inclusion and Exclusion Criteria in Clinical Research (Writing, Assessing for Broad vs. Narrow, Organ Dysfunction, Older Adults, Pediatrics, Pregnant Women)

    • Protocol Deviations and Violations (Major, Minor, Exceptions, Resolution)

  • 13

    Project Management Scheduling and Tracking

    • Basics of Project Scheduling

    • Project Progress Tracking

    • Project Management Planning Process

  • 14

    Project Management Plan

    • Project Management Planning Process

    • Closing a Project

    • Project Delays

    • Process Mapping

    • Metric Tracking

  • 15

    Duties of a Successful Project Manager

    • Roles and Responsibilties of a Project Manager

    • Project Management Success Factors

  • 16

    Adverse Events

    • Advanced Review of Adverse Events

  • 17

    Site Selection and Visits

    • Types of Monitoring Visits (Selection, Initiation, Routine, Close-Out)

    • Site and Investigator Selection Criteria (Process, Criteria, Investigator Selection, Agreements, Decision-Making)

    • Site Selection/Qualification Pre-Study Visit (SSV/SQV) (Before, During, After, Letters, Checklists, and Report)

  • 18

    Audit and Inspections

    • Audits and Inspections in Clinical Trials

    • Clinical Trial Data Audits

    • FDA Warning Letter

  • 19

    Quality Control and Safety

  • 20

    Technology in Trials (IVRS, CTMS, EDC)

  • 21

    Pharmacovigilance and Regulatory Affairs

    • Advanced Practice of Pharmacovigilance

    • Regulatory Affairs for Clinical Trials

  • 22

    Investigational Product and Labs

  • 23

    Patient Recruitment, Retention, and Compliance

    • Patient Recruitment in Clinical Trials

    • Patient Engagement and Retention in Clinical Trials

    • Patient Adherence and Compliance in Clinical Trials

  • 24

    Project Manager Job Readiness

    • Project Manager Skills Interview Questions

    • Interview Questions

  • 25

    Competency Examination

    • Competency Exam

Ready to become a manager?

Working in research and ready to be promoted into the clinical trial project management side? Already a project manager and want to specialize as a pharmaceutical project manager? CCRPS provides the most advanced clinical trial project manager course for professionals to get hired and promoted in the field.
Clinical Research Project Manager

The most advanced clinical trial project management training available

  • Take the fast track

    Take the fast track to a lucrative career as a Clinical Research Project Manager to start earning salaries of $100k+

  • Get advanced training

    Get the most advanced training - ACRPM is recognized as a gold standard by many CROs in the industry thanks to its comprehensive training

  • Work at your own pace

    Work at your own pace from wherever you are with flexible online training. The 100+ modules included can be completed in as little as 2 weeks

  • Requirements

    Designed for those holding a minimum of a BA in Science, ACRPM is internationally accredited to ACCRE, ACCME, ACPE, ANCC, and Transcelerate Biopharma. In other words, upon completion of the course and the final exam, you will have a level of knowledge equivalent to (and beyond!) that of a senior CRA.

  • Syllabus

    ACRPM features 100+ modules, or 250 hours, of on-demand online training (worth 17.5 CME credits). The course has been put together by clinical trial project managers, enabling students to build a deep knowledge of the industry.

  • Certification

    This course can be completed in as little as two weeks, with certification and a letter of recommendation awarded after completing a final exam. ACRPM also provides you with tools to help you find a job, including resume and interview guides, giving you a further edge over other applicants for the same position.