Graduate Clinical Trial Management

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

OVERVIEW

Why Clinical Trial Management

This course provides training for students to learn how the Clinical Trial Management process works, the development of complete Regulatory activities 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. It will be done through real-time Case Scenarios, Clinical Tasks, and other Site Management activities taught by industry experts.

Highlights

  • In our Internship program, students work as Clinical Research Coordinator, Clinical Research Associate, or Clinical Trial Assistant to gain knowledge and experience to be job-ready from Day 1.
  • 20+ weeks of hands-on training in Clinical Trial Management System and Electronic Trial Master file. Full access to cases, protocols, and scenarios in the existing production systems.
  • Students will receive TWO certificates at the end of the Program:
  • a.Course Completion Certificate upon successful completion of all courses and assignments
  • b.Internship Completion Certificate as Clinical Research Intern  upon successful completion of all Academic internship requirements
  • Students are guided by our Industry Career Advisors with more than 15 to 30 years of related domain experience. These Advisors guide the graduates in resume and interview preparation in a small group and one-on-one sessions.
  • The students will have continued access to the program content, presentation, class recordings, and complete tool access for up to one year of program completion. It helps in interview preparation and knowledge review.
  • We provide a reference as a Clinical Research Intern upon successful completion of the Academic internship.

Learning Outcomes

The in-house 20+ weeks of the internship include hands-on training in the Clinical Trial Management and eTMF system. The overall workflow is created as a day-to-day activity. 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.
  • As a CRA, students will Generate Visit Tasks/Reports as required by the Sponsor and submit the report for review.
  • Students will work on the Site binder and trial binder in the eTMF system.
  •  Students will be working with documentation related to local and central IRB (Regulatory board)
  • Work on Investigation products and applicable local regulatory authorities in managing the products
  • 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 them.
  • In addition, students also work with document Placeholders, Signature WorkFlows, TMF Metrics to successfully perform Site Master File/Trial Master File Reconciliation.

Syllabus

  • Phases of the Clinical Trial
  • ICH-GCP Guidelines
  • Study Feasibility/Site Selection
  • IRB/IEC
  • Budgets
  • Contracts
  •  Essential Documents (Prior to Study Start)
  •  Financial Disclosure Form
  •  Clinical Trial Protocol
  • Investigator Brochure
  • Informed Consent Process
  • Monitoring- General introduction to all the types of visits Study Conduct
  •  Medical Devices
  •  Fraud/Misconduct/Potential Liability
  • FDA Inspection
  • Essential Documents (During Study Conduct) Study Close Out
  • Site Close-Out Visit (On-Site/Remote activities)
  • Statistical Analysis
  • Investigational Drug Application
  • New Drug Application
  • eCTD (Common Technical Document)
  • Essential Documents (After Study Close-Out)
  • Risk-Based Monitoring
  • Evidence Based Medicine
  • Personalized Medicine
  • Big Data

INTERNSHIP

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
 

eTMF-Electronic Trial Master File

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


Dr. Persis Bandari

Faculty of Clinical Trial Management


Nisha Philipose

Faculty of Clinical Trial Management


Dr. Geetasree Alluri

Teaching Assistant for Clinical Research


Course Duration

20 to 24 weeks (20+ hours each week)

3 Sessions /week

Engagement

300 hours

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

Credit transfers applicable for alumni

OUR STUDENTS WORK AT

Sollers partners with industry-leading corporations and provides them with ready-on-day-one employees. We record an 82% placement rate within three months of graduation.

Financial Options

Sollers has devised viable financial options for you to ensure tuition does not get in the way of your education. Now, you can focus your attention where it needs to be – in the classroom!

Career Guidance

After the completion of program, we assist our students with interview coaching, resume building sessions, conduct mock interviews, job readiness training and make them competent to venture into the corporate world.

We provide exclusive one-on-one sessions with our industry-based career advisors who provide guidance right from resume feedback, assisting with interview Q&As, and helping with job preparations.

Student Testimonials

  • Emmanet T.
    The Clinical Trial Management course is extensive, and the professors are thorough in delivering the course materials using real life experience and insight. Career Services helped me throughout the interview process, and I landed my dream job with the very first interview after graduating from Sollers.
    Emmanet T.
  • Rudolf M.
    Thanks to the academic team at Sollers, I was able to gain quick admission with financial options to pay tuition. Career Services was very helpful with resume and interview prep. They sent me job postings with major hospitals and pharma companies which helped me land my current job as Data Manager in cancer clinical trials.
    Rudolf M.

Campus Visit

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.