Advanced Clinical Research

Learn to conduct clinical research, collaborate with clinical scientists and enhance your skills in patient-oriented research.

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Overview

OVERVIEW

Why Clinical Trial Management?

This course provides training for students to learn how the Clinical Trial Management process works, developing complete Regulatory activities involved in Creating Documents and in 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 Risk-based Monitoring concepts.

In This Course

Study Startup: Understand the phases of the Clinical Trial, ICH-GCP guidelines, Study Feasibility, and Site Selection. Study Conduct: Learn about Site Monitoring Visits, which include Remote and Central Risk-Based Monitoring. Study Closeout: Learn about Site Close-Out Visit including both On-Site and Remote activities.

The Sollers Advantage

Work on real-time Case Scenarios, Clinical Tasks, and other Site Management activities taught by industry experts.

Learning Outcomes

LEARNING OUTCOMES

  • 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 the Site binder and trial binder in the eTMF System
  • Students will be working with documentation related to local and central IRB (Regulatory board)

Syllabus

Register now, to get the complete syllabus.


    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.

    Course Duration

    15 weeks (20+ hours each week)

    3 Sessions /week

    Engagement

    150 hours

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

    Credit transfers applicable for alumni

    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!

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    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.

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    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,

    Campus Visit

    FAQs

    How long is the program?

    This is a 300 Hour program

    Who is this program suitable for?

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

    Are there any prerequisites?

    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.

    What will you walk away with?

    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

    What practical skill sets can I expect to get after completion of the course?

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

    Whom will I be associating with?

    Excellent and versatile senior faculty from Clinical trial industry.

    Why is this course relevant today?

    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.

    ClinicalTrials.gov reports a total of more than 250,000 Trials

    Industry Facts

    The growth of clinical research

    Clinical Research has proven to be exceedingly more necessary by health organizations and pharmaceutical companies in today’s modern age. This trend can be summarized by two realities: higher rates of chronic diseases and a fast-growing global population. These two elements combined, create a need for the technological advancement throughout the industry; methods and techniques that can be developed quickly to help treat the growing medical issues of today and of the future (Yau, Promising Futures for Scientific and Clinical Research Professionals, 2014).

    Clinical Research has just been ranked as one of the hottest jobs with the 2nd highest salary in the life sciences sector in a BioSpace news article today. (READ MORE)

    The highest paying life sciences jobs.

    Importance of clinical trials. (READ MORE)

    Growing demand for clinical trial studies justifying the demand for qualified clinical trial professionals.