Graduate Certificate in Clinical Trial Management

Work with the latest industry tools and learn how to apply them in the domain of Clinical Trial Management.

Clinical Trials Management Certification Course Online

The Clinical Trials Management Certification course at Sollers College offers extensive training to individuals aspiring to excel in the field of clinical research. From study design and regulatory compliance to data management and ethical considerations, we ensure that each candidate has a well-rounded understanding and training in clinical trials. Our clinical trial courses encompass top-tier education along with hands-on training, access to industry experts, and networking opportunities. Join Sollers College for the best clinical trial training and elevate your career to new heights.

OVERVIEW

Why Clinical Trial Management Course

This course provides training for students to learn how the Clinical Trial Management process works, complete Regulatory activities involved in Creating Documents and Planning, Organizing, Monitoring, Recording, Analysis, and Reporting of Clinical Trials. The program provides additional opportunities to learn about recent advancements as well as specializations in e-Clinical Technology.

In This Course

Students will have 20+ weeks of hands-on training with Clinical Trial Management System and Electronic Trial Master File Management System from Site Initiation, Site Monitoring, and Closeout. This will do through real time Case Scenarios, Clinical Tasks, and other Site Management activities taught by industry experts.

CLINICAL TRIALS COURSE HIGHLIGHTS

Internship: In our Internship program, students work in different positions in Clinicalfield  to acquire experience to be job ready from Day 1.

Training: 20+ weeks of training in Clinical Trial Management System and Electronic trial Master file with cases, protocols and scenarios with full access.

Certificate: TWO Certificates, Course Completion Certificate and Internship Completion Certificate as Clinical Research Intern.

Career Guidance: Our career service advisors provide guidance for the resume and interview preparation.

Curriculum: Job-oriented, industry-based curriculum, full-fledged access to program content, batch recordings, and tools after one year of program completion.

References: References for the jobs as a Clinical Research Intern.

LEARNING OUTCOMES

The in-house 20+ weeks of internship includes hands-on training in the Clinical Trial Management and eTMF system.The overall workflow is created as a day to day activity  and our students work as a Clinical Research Associate in a real-time environment with multiple cases to gain the knowledge and experience to be job ready from Day 1.

  • Understand and implement Site selection,Site initiation,Site monitoring and  various other Site activities Activities
  • Students will assign sites, Site staff, IRB and labs to the Pre designed studies in the CTMS as a CRA
  • Students work on various Documents related to Site Visits as per the regulatory bodies requirement
  • Students will  work on Site binder and trial binder in the eTMF System
  • Students will be working with documentation related to local and central IRB (Regulatory board)
  • As it is a highly regulated field, our internship program uses electronic Trial Master File (eTMF) to upload/index documents, use naming conventions and electronically sign the documents before submitting.

Clinical Trials Training Syllabus

Download the full clinical trial training course syllabus using the form below.


    Clinical Trial Management Internship Program

    Sollers offers a 20 to 24 weeks 300 hours internship as part of the Clinical Trial Management program that helps you gain practical experience on key concepts taught during the course. You will work on:

    CTMS – Clinical Trial Management system

    Nisha Philipose

    Faculty of Clinical Trial Management


    INSTRUCTORS

    Our instructors are not just highly experienced in the industry, they give you the personal attention you need and guide you every step of the way.

    Padma Iyer

    Faculty of Clinical Research


    Mark Koscin

    Faculty of Clinical Research


    Nisha Philipose

    Faculty of Clinical Trial Management


    Dr. Geetasree Alluri

    Teaching Assistant for Clinical Research


    Clinical Trial Course Duration

    20 to 24 weeks (20+ hours each week)

    3 Sessions /week

    Engagement

    300 hours

    Program Mode:

    Hybrid

    For information regarding fee and/or reserving your spot, contact our Admissions Team.

    Credit transfers applicable for alumni

    Clinical Trials Course Modules

    1. Introduction to Clinical Trials
    2. Regulatory Framework
    3. Roles and Responsibilities
    4. Phases of Clinical Trials
    1. Investigational Product Management
    2. Protocol Development
    3. Patient Safety and Monitoring
    4. Site and Trial Management
    5. Trial Oversight
    1. Clinical Data Management
    2. Electronic Data Capture (EDC) Systems
    1. Introduction to Clinical Trial Operations
    2. Advanced Functions of CTO
    1. Clinical Project Management Basics
    2. Advanced Project Management
    1. Regulatory Affairs
    2. Medical Writing
    1. Epidemiology and Public Health
    2. Biostatistics
    1. SAS Programming for Clinical Trials
    2. Advanced Data Analytics
    1. Decentralized Clinical Trials (DCT)
    2. Digital Health Technologies
    1. Real-World Evidence (RWE)
    2. Patient-Centric Trials

    INTERNSHIP PROGRAM

    Sollers offers a 20 to 24-week, 300-hour internship that provides practical experience in clinical trials management, applying course concepts to real-world scenarios.

    CAREER SUPPORT

    Experts With Over 15 Years Of Professional Industrial Expertise Guiding And Coaching Students To Polish Their Resumes And Prepare For Interview Success!

    LINEAGE OF A DECADE

    For More Than 10 Years Sollers College Has Been Paving The Way For Education Offering Top Notch Insightful Programs Along With A Broad Alumni Network For Engagement.

    Career Opportunities in Clinical Trials Management

    • Clinical Research Associate (CRA)
    • Clinical Trial Manager
    • Clinical Data Manager
    • Regulatory Affairs Specialist
    • Clinical Project Manager
    • Clinical Research Coordinator (CRC)
    • Site Manager
    • Quality Assurance Auditor
    • Clinical Operations Specialist
    • Clinical Monitoring Lead

    Student Testimonials

    • Suma D
      with a background of B.Pharm in India, worked as a clinical pharmacist for four years before moving to the US and joined Sollers. She has completed the Advanced Drug Safety and Pharmacovigilance certification program in 2016. After two years of a career break, she has done a certificate program from Sollers. Sollers College has prepared her to offer as a drug safety associate in Bioclinica even after a two-year career gap. Now she is pursuing an MS program in DSP.
      Suma D
    • Suman B
      With a Ph.D. in Pharmaceutical Sciences background, Suman B worked as a drug safety associate in India. He pursued the ADSP course in Feb 2020. Sollers College has inspired him to move one step forward and try new things and help him leave that comfort zone. He got placed as a safety data associate within six months before the start of the internship.
      Suman B
    • Rebecca J
      Foreign Medical doctor, Singapore, completed a diploma in family medicine in 2008, worked as a physician before moving to the US in 2015, joined Sollers for the ADSP program in Jan 2019. Under the guidance of professors, he grasped the knowledge of Career growth in the Healthcare sector. Soller College has inspired him to go the extra mile and try new experiences outside his comfort zone. After certification, he was settled as a Regulatory Post Marketing Safety Specialist for a medical device company.
      Rebecca J
    • Viraj P,
      with a background of Pharm D, worked as a pharmacist and Pharmacy Manager. He joined the Advanced drug Safety program in 2019. Sollers provides a host of real-world opportunities for him. He was involved in working on real-time case scenarios. Sollers supported him by giving interview tips and resume preparation. After completing the certification, he is working in his interesting zone with a PV clinical associate position.
      Viraj P,

    Clinical Trial Course FAQs

    This is a 300 Hour program

    Graduates from science, nursing, pharmacy, medical, dental, and computer background can take this program.

    Basic knowledge to work with Computers, quick learning aptitude to get trained in newer software application tools, company SOP, Medical terminology, Clinical SAS, willing and ready to travel.

    • Understanding of ICH/GCP clinical trial paradigm, Roles and responsibilities of various functionaries of Clinical trial process.
    • Detailed training of Clinical Trial Manager, Monitor, Coordinator, Data analyst functions

    Be proficient to work on EDC based Risk Based Monitoring along with user friendly knowledge of relevant tools like CTMS, eTMF, Clinical SAS.

    Excellent and versatile senior faculty from Clinical trial industry

    • Clinical Trials are ever expanding area for drug development process.
    • More than 20,000 Trials were added during 2016 with annual increments of at least 6% per annum.
    • Clinical Trials.gov reports a total of more than250,000 Trials

    Yes, Internship provides an excellent opportunity for practical hands-on working experience on virtual life like functionality of various functions.