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Clinical Trial Operations: Feasibility, Study Start-Up & Monitoring

Course Description

This 2-day interactive program provides practical, real-world insights into three critical pillars of clinical trial success: feasibility, study start-up, and monitoring. Participants will learn how to design and implement feasibility strategies, navigate operational and regulatory considerations in start-up, and apply monitoring best practices to ensure compliance, quality, and inspection readiness. Real-world case studies and group exercises will reinforce learning and enable attendees to apply concepts directly to their work.

Course Summary

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2 Days
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09:00 AM - 04:00 PM EST
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$1795 by Early Bird Deadline
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$1995 after Early Bird Deadline

Upcoming Courses

Terms & Conditions

Learning Objectives

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    Design and implement feasibility assessments, including evaluation of patient recruitment and retention potential
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    Develop realistic study start-up plans and timelines
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    Understand essential study documents, contracts, and budget elements in start-up, including their purpose, regulatory requirements, and maintenance
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    Apply informed consent and participant enrollment best practices
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    Understand monitoring approaches, including risk-based monitoring principles
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    Maintain inspection readiness and continuous quality oversight
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    Recognize and manage protocol deviations effectively
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    Understand the fundamentals of clinical trial data management and documentation workflows
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    Incorporate diversity, equity, and inclusion considerations into feasibility, recruitment, and site selection strategies

Who Should Attend

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    Clinical Research Associates (CRAs)
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    Clinical Trial Assistants / Clinical Research Assistants
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    Clinical Research Coordinators / Data Entry Coordinators
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    Clinical Research Managers / Project Managers / Research Program Managers
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    Clinical Trial Monitors / Data Managers
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    Anyone eligible and interested in building or advancing a career in clinical research

Course Outline

Day One - Saturday

1. Feasibility Planning: Protocol & Site Considerations - Strategic role of feasibility, data sources, diversity considerations, site selection, and recruitment potential

2. Study Start-Up Fundamentals & Timelines - Workflow from award to site activation, key milestones, interdependencies

3. Informed Consent & Essential Documents - Regulatory expectations, ICF development, essential document collection and maintenance

Day Two – Sunday

1. Monitoring Strategies & Inspection Readiness - On-site and remote monitoring, quality oversight

2. Data Management Principles - Overview of data flow, CRFs, query resolution, and EDC system fundamentals (based on publicly available examples)

3. Protocol Deviations & Continuous Quality Oversight - Identifying, documenting, and managing deviations; CAPA development

Interactive Activities
  • •Case Study 1: Scoring and selecting sites based on feasibility data
  • •Case Study 2: Resolving a monitoring finding and developing CAPA
  • •Case Study 3: Drafting a start-up and monitoring plan for a sample protocol
Noushin Taghavi, MD, PhD.
Faculty Director’s Bio:

Noushin Taghavi, MD, PhD.

Clinical Research Leader | Educator | Feasibility & Study Start-Up Expert | Global Trial Strategist

Dr. Noushin Taghavi,MD, PhD. is an accomplished Clinical Research and Medical Affairs professional with over 15 years of progressive experience spanning academic research institutions, hospitals, and top-tier global pharmaceutical companies. She has built a distinguished career in feasibility strategy, clinical operations, site engagement, and biomarker-driven research across Phase I–IV studies, with a strong focus on oncology.Currently serving as a Site Engagement Liaison at Pfizer/ICON, Dr. Taghavi specializes in study start-up activities, including pre-trial assessments, site initiation visits, and site activation. In this role, she partners closely with investigative sites to ensure operational readiness, accelerate recruitment, and maintain quality and compliance from study launch onward.Prior to joining Pfizer, Dr. Taghavi served as Senior Manager for Clinical Operations and Site Engagement at Bayer, where she led feasibility planning and portfolio delivery for diverse therapeutic areas across North America. Her work included protocol- and site-level feasibility, cross-functional risk assessments, and the integration of real-world evidence and diversity considerations into feasibility strategies. She also completed a postdoctoral fellowship at the Ontario Institute for Cancer Research (OICR) in Toronto, Canada, focusing on oncology research and contributing to biomarker and precision medicine initiatives. Earlier in her career, she worked as a Clinical Research Coordinator and Clinical Research Officer at Sunnybrook Health Sciences Centre and Michael Garron Hospital, giving her an in-depth understanding of clinical trial operations from the site perspective.

Dr. Taghavi is recognized for her ability to lead cross-functional teams, build strong relationships with investigators and key opinion leaders, and translate complex scientific and operational challenges into actionable strategies. She has been awarded multiple Top Performance Awards for excellence in trial execution, stakeholder engagement, and operational delivery.

In addition to her operational leadership, Dr. Taghavi is deeply committed to education and mentorship in clinical research. She has delivered training on multiple aspects of clinical research, including feasibility assessment, start-up, monitoring, and study document development, and is experienced in public speaking, teaching, and contributing to the scientific community through publications and conference presentations. Her teaching style blends scientific rigor with real-world application, empowering professionals to meet the demands of today’s evolving research environment.

With a strong foundation in oncology and a passion for improving patient outcomes through innovation, diversity, and collaboration, Dr. Taghavi continues to be a sought-after leader and educator in clinical research. She believes that excellence in clinical trials begins with empowered teams, inclusive trial design, and a shared commitment to quality and patient-centered care.

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Global Pharma companies and CROs employing our graduates

Global Pharma companies and CROs
employing our graduates

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