Career Development

• Explain the phases I-IV of clinical research, including pharmaceutical development, and the purpose and characteristics of each phase.
• Explain the steps involved in conducting a clinical trial from a pharmaceutical company or CRO perspective from protocol development to final report.
• Identify core ethical principles and guidelines for the protection of human subjects and to ensure data integrity.
• Describe specific regulations, guidelines, and measures designed to protect study participants and monitor study data.
• Locate and apply Good Clinical Practice (GCP) guidelines to clinical research scenarios.
• Explore and identify key roles and responsibilities of clinical research careers.

Module Objectives

• Learn key concepts and expand their knowledge of the clinical research industry.
• Prepare for a career in this viable industry.
• Conduct clinical research in their clinical practice.

We utilized six clinical research professionals in various fields with more than 140 years of collective experience in the industry. These instructors collaborated to produce an introduction and overview of clinical trial operations. We offer this course from a career perspective and provide resources to help participants break into the industry.

• 100% of participants said that the course was a good value for money.
• Fast Track provided me [with] insight into the clinical research industry, the different critical components, functional areas and career opportunities available."
• This knowledge allowed me to decide which position would be the best fit for my business background and career aspirations."

Instructor Bios

• Recognize key regulations, guidance and industry standards that apply to clinical data management
• Recall common clinical data management roles
• Describe common clinical data management documents
• Give examples of common clinical data management systems
• Summarize principles of clinical database and data collection instrument design
• Recall key elements of quality, compliance and inspection readiness
• Explain the typical clinical data management project life cycle 
• Perform core tasks of data entry, date review and query management

This course is designed for people who:

• Have a basic understanding of the clinical research industry but wish to learn more about data management
• Enjoying learning new software systems and gaining hands on experience
• Are seeking employment in the clinical research industry in data management

Students will gain access to the MediED clinical data management system and will perform hands-on tasks to receive certification from UNCW and digital badges from Medidata Rave. Following successful completion of the course, students will be invited to join Medidata’s MediED Alumni LinkedIn for updates on technology advancements and updated trainings.

• We heard the needs of our past Fast Track students and created this course to meet the demand for experience in clinical data management systems.
• Linda is a Qualified Clinical Research Trainer through the International Accrediting Organization for Clinical Research (IAOCR).

Linda Shostak has more than 18 years of experience in clinical research in the areas of data management, quality assurance and project management. She is currently an instructor at UNC Wilmington and Senior Director of Biometrics Optimization and Training at Syneos Health.

Shostak has participated in numerous clinical research studies in the areas of oncology, general medicine and rare diseases. She teaches data management to both undergraduate and graduate students in the UNCW Clinical Research program.