Why Choose the md´«Ã½¹ú²ú¾ç College Clinical Research Certificate Program?

  • Gain an understanding of clinical research methodologies, regulations, and best practices. Equip yourself with the knowledge demanded by top pharmaceutical companies, research institutions, and healthcare organizations worldwide.
  • Elevate your career prospects with a respected certificate.
  • Learn from industry experts and accomplished professionals who bring real-world experience to the classroom. Benefit from their insights and guidance.
  • OurÌýprogram offers flexibility to suit your schedule. A varied live, online course schedule allows you to choose an iteration that works around your other commitments.
  • Put theory into practice with practical exercises and case studies. Gain a broad perspective of clinical trials, collecting data, and analyzing results to prepare for your career as a clinical research professional.
  • Connect with fellow students, alumni, and industry experts. Build a powerful professional network.

Whether you aspire toÌýbecome a Clinical Research Associate, Clinical Trial Coordinator, RegulatoryÌýAffairs Specialist, or Clinical Data Manager, our Clinical Research CertificateÌýprogram will empower you with the knowledge and skills to excel in this dynamicÌýand vital field.

This certificate program consists of three courses that will provide you with the tools you need to become successful in today's rigorous marketplace.

  • Clinical Research: Principles, Protocols and Procedures
  • Project Management in Clinical Research
  • Career Pathways in Clinical Research

Each session is taught by an instructorÌýcurrently working in that topic area.ÌýThey work at organizations including: md´«Ã½¹ú²ú¾ç Children’s Hospital, Centrexion Therapeutics, Deciphera Pharmaceuticals, EMD Serono, Inc., EndPointe Clinical Resources, Inc, Harvard T.H. Chan School ofÌýPublic Health, ImmunoGen, Inc., Johnson & Johnson (Janssen Oncology), Medidata, Merck, Propel Careers, QurAlis, Takeda Pharmaceuticals International Co.,ÌýValerio Therapeutics

See Course Descriptions and Times in the Tabs Below

Clinical Research: Principles, Protocols and Procedures

The content of this course is designed to provide a thorough overview of clinical research conduct, the drug development process, the roles of the Clinical Research Associate and Clinical Research Coordinator, and other key roles in the conduct of clinical research.

This course meets for 10, three hour sessions:
Session 1: Overview of the Clinical Research Process
³§±ð²õ²õ¾±´Ç²ÔÌý2:ÌýClinical Research Personnel, Service Providers, and the Site Selection Process
³§±ð²õ²õ¾±´Ç²ÔÌý3: Human Subject Protections and Regulatory Oversight
³§±ð²õ²õ¾±´Ç²ÔÌý4: Clinical Trial Conduct, Monitoring and Record Keeping
³§±ð²õ²õ¾±´Ç²ÔÌý5: Components of Ethical Evaluation of Human Research and Privacy Considerations
Session 6: Recruitment and Retention, Drug Compliance and Accountability, and Study Close-Out Procedures
Session 7:ÌýPharmacovigilance in Drug/Device Development
Session 8:ÌýAudits & Inspections: Ensuring Clinical Research Quality
Session 9:ÌýThe Role of Data Management in Clinical Research
Session 10:ÌýStudy Budgets and Contracts: Evaluation and Negotiation

Course Fee

$1899
(includes $75 book fee)

30 Contact Hours
Fall 2024

Ìý

Thursdays, September 19 to November 21, 2024
6:00 - 9:00 PM ET

Ìý

Live on Zoom
Winter 2025

Saturdays, February 15 to
March 15, 2025
9:00 AM - 3:30 PM*

* Two sessions per day with a
30 minute break in between.
(9:00 - 12:00 and 12:30 - 3:30)

Live on Zoom
Spring 2025

Ìý

Tuesdays and Thursdays,
May 6 to June 5, 2025
6:00 - 9:00 PM

Ìý

Live on Zoom

Project Management in Clinical Research

This course will provide an overview of the project management processes: initiation, planning, project life cycle, effective team building, execution, monitoring, tracking, risk management, change management, contingency planning, and close-out processes and procedures.

This course will benefit professionals interested in pursuing a clinical research career by providing a clear understanding of project management principles and processes.Learn industry trends and best practices through real-world examples involving team projects and case studies presented by experts in the industry. Through discussion, presentation, and interaction, this course will broaden the participants' knowledge of the project management process in clinical research.

At the conclusion of this educational activity, participants will be able to:

  • Define a project and project management
  • Describe the project phases and life cycle
  • Understand how project management is applied for a clinical research project
  • Summarize activities in project scope, time, and cost management in clinical research
  • Understand project risk management and mitigation planning
  • Describe project quality management
  • Understand project communications
Fall 2024

Tuesdays, October 1, 8, 15Ìý & 22, 2024
6:00 - 9:00 PM

Live on Zoom
Winter 2025

Saturdays, March 29, April 5 & 12, 2025
9:00 AM - 1:00 PM

Live on Zoom
Spring 2025

Tuesdays and Thursdays,
June 10, 12, 17, & 19, 2025
6:00 - 9:00 PM

Live on Zoom
Course Fee

$629

12 Contact Hours

Career Pathways Clinical Research

This course deals with the challenges related to managing change associated with career transition. Understand the clinical research field as well as your career strengths, career interests, and values. In addition, focus on your uniqueness and its value to yourself and the marketplace. Identify transferable skills and accomplishments that can be used in clinical research. Learn from clinical research experts how to market yourself and how to enter the clinical research arena.

This course is presented in two sessions that will prepare you to confidently embark on your job search.Ìý

Session 1:ÌýComputerized Systems in Clinical Research
Clinical Trial Management System SoftwareÌýReview of Clinical Trials

  • Electronic Data Capture (EDC)
  • Clinical Trial Management Systems (CTMS)
  • Risk Based Monitoring (RBM)

³§±ð²õ²õ¾±´Ç²ÔÌý2:ÌýTransitioning into and Growing a Career in Clinical Research
Résumé Basics, Job Search Strategies, and Internet Marketing

  • Overview of clinical research rolesÌý
  • Tips to structure a job searchÌý
  • RésuméÌýtipsÌýInformational interviewing to accelerate a search
  • Social media tools (LinkedIn) for your searchÌý
  • NetworkingÌý
Course Fee

$299

6 Contact Hours
Fall 2024

Tuesdays, November
5 &Ìý12, 2024
6:00 - 9:00 PM

Live on Zoom

________________________________________________

Winter 2025

Monday & Wednesday, April
28 & 30, 2025
6:00 - 9:00 PM

Live on Zoom
Spring 2025

Tuesday &ÌýThursday,Ìý June 24 &Ìý26, 2025
6:00 - 9:00 PM

Live on Zoom

These multidisciplinary courses have been designed for professionals interested in moving into the field of pharmaceutical/clinical research. Hospitals and pharmaceutical companies seek out nurses or people with a science background for these roles because they have a scientific knowledge base, good interpersonal skills, and experience working with physicians and other nurses. Participants also use this certificate program as a refresher or as a review for certification examination.This certificate program provides you with the tools you need to become successful in today's rigorous marketplace.Ìý

To earn a certificate, a student must successfully complete all of the required courses within a two-year period.ÌýIn order to receive contact hours, participants must attend the course and complete the examinations.

Contact

617-552-4256