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Webinars

August | September | October |

August

August 14 - October 16, 2014

Barnett International

30-Hour Clinical Project Management Fundamentals Certificate Program

5:00 PM - 8:00 PM Eastern

In today’s outsourcing environment, the need for strong project management skills is greater than ever. This comprehensive hands-on 30-hour course is designed to provide the tools necessary to become a strong project manager in clinical research. Whether you are looking to become a clinical research project manager, you are already in an entry-level project manager role or you have become an “accidental” project manager by assignment, this program will provide you with project management skills development as well as the necessary tools and processes required to successfully manage projects in clinical research settings. The course includes an emphasis on the need to anticipate, understand, and implement detailed project management activities in a proactive manner. Discussions, exercises, and tools are practically oriented with an emphasis given to practical application of key concepts and principles.

August 15 - October 24, 2014

Barnett International

10-Week Clinical Research Coordinator (CRC) On-Boarding Program

12:00 PM - 3:00 PM Eastern

The Clinical Research Coordinator (CRC) has a vital role in the conduct of a clinical trial and is a key liaison between the investigator, subject, IRB, and sponsor. The online 10-Week Clinical Research Coordinator (CRC) On-Boarding Program will provide a comprehensive introduction to clinical research and the job functions of the CRC for both drug/biologic and device trials. This program will provide core skills and encourage critical thinking to those individuals looking to support, facilitate, and coordinate the daily activities of clinical trials. Case studies and industry best practices will be presented to underscore how the learning objectives apply directly to the responsibilities of the CRC.

September

September 5, 2014 - November 7, 2014

Barnett International

10-Week Clinical Research Associate (CRA) On-Boarding Program

8:30 AM - 11:30 AM Eastern

The online 10-Week Clinical Research Associate (CRA) On-Boarding Program is appropriate for individuals with less than two years of experience as a CRA. The course provides practical, hands-on training as it relates to the CRA job function, and covers core sponsor and research site activities that promote the successful monitoring of studies for drug, biologic, and device trials. The course follows an ICH/ISO global GCP framework, and covers how to identify specific country requirements, making it appropriate for both U.S. and global audiences. Good Clinical Practice (GCP) skills are reinforced through a combination of activities, including lecture, case studies, and scenario review, as well as application-based homework assignments.

September 25, 2014

Barnett International

Regulatory 101: Navigating the Background, Laws, and Pertinent Regulations

12:00 PM - 1:30 PM Eastern

Complex regulations govern the development, manufacture, and commercialization of biomedical products. This web seminar will help participants understand the U.S. regulatory requirements for patented and generic pharmaceuticals, over-the-counter drugs, biologicals, and medical device products. Participants will gain high-level knowledge and insight into the regulatory agencies and their roles and responsibilities, regulatory applications and pathways, and post-marketing requirements. This is an important course both for those entering the biomedical profession and for those already in the profession to learn more about the laws governing this industry.

September 26, 2014

Barnett International

Strategies for Developing Effective Training and Facilitation Skills in Clinical Research

9:30 AM - 11:00 AM Eastern

In clinical research, there is an on-going need to conduct training whether it is at the onset of a study, due to a change in staff or new staff, as a result of an amendment, or because of an identified noncompliance issue during a study. If our goal in training is to pass on knowledge and to ask learners to apply that information, we need to consider our approach in how to make this happen. It is important to consider how essential every communication is within research; the information shared can have a huge impact on study timelines, data integrity, and compliance.

September 29, 2014

Barnett International

Introduction to Statistics for Non-Statisticians

8:30 AM - 11:30 AM Eastern

This web seminar is intended for clinical research professionals who have little or no background in statistics. In it, we will cover the basic statistical concepts needed to understand the roles statistics play in health research. The topics addressed include types of variables, levels of measurement, descriptive statistics, precision, confidence intervals, and an introduction to hypothesis testing. This web seminar is beneficial to all clinical research professionals involved in the design, monitoring, interpretation, and reporting of clinical trials. Emphasis will be placed on understanding statistical information and not on calculations or statistical formulae.

September 29, 2014

Barnett International

Good Clinical Practice: Practical Application and Implementation

9:30 AM - 11:30 AM Eastern

This web seminar provides an overview of the structural elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to how Quality Systems, or a lack thereof, impact overall data quality and regulatory risk. This web seminar is designed for professionals with at least two years of experience in the clinical research industry.

September 29, 2014

Barnett International

FDA's Bioresearch Monitoring (BIMO) Program: Inspection of Sponsors, CROs, and Monitors

12:30 PM - 2:30 PM Eastern

This web seminar includes a detailed review of the FDA’s Compliance Program Guidance Manual (CPGM) on how agency investigators are trained to conduct inspections of sponsors, Contract Research Organizations (CROs), and monitors involved in the conduct of clinical research. The course will look at the FDA’s current focus during inspections and the factors driving these changes. Assessment and discussion of the standard operating procedures that are expected for sponsors and CROs, including registration of trials and informed consent document issues, will be highlighted.

September 29, 2014

Barnett International

CRC Role/Responsibilities Training

1:00 PM - 3:00 PM Eastern

The Clinical Research Coordinator (CRC) can be a key liaison between the investigator, subject, Institutional Review Board (IRB), and sponsor. The CRC assists the investigator to ensure that the clinical trial is successfully implemented and completed. This web seminar presents the core skills and activities performed by the CRC and the documentation requirements that come along with clinical trials.

September 30, 2014

Barnett International

Fraud in Clinical Research: An Overview

12:30 PM - 2:30 PM Eastern

Fraudulent activities in clinical research undermine clinical research professionals’ ability to meet their obligations for ensuring credible data is obtained from protected participants. This web seminar provides an overview of fraud in clinical research and its potential impact on the industry and the public’s health.

October

October 1, 2014

Barnett International

Adequate Sponsor Monitoring Systems in Anticipation of FDA Sponsor GCP Inspection

12:30 PM - 2:30 PM Eastern

In the current regulatory climate, sponsors should anticipate more FDA sponsor GCP inspections and information requests regarding monitoring practices. Many monitoring systems lack components that ensure proper management of the research site without relying on the “star performer.” Monitoring systems should include specific components to ensure control of investigational product, data integrity, oversight of vendors, as well as other areas. The components of a quality monitoring system will be presented so that participants can assess their current practices for identifying gaps and risks, particularly in relation to preparing for regulatory inspections of sponsor monitoring programs.

October 2, 2014

Barnett International

Critical Decision Points in Design and Conduct of Patient Registries

12:00 PM - 1:30 PM Eastern

Patient registries are based on principles of observational research and offer remarkable flexibility in design and applications. They have demonstrated value in both the biopharmaceutical and the medical device arenas. Patient registries are appealing to physician investigators, and can serve as a centerpiece or as an adjunct to a product’s late-phase scientific and promotional strategy.

October 2, 2014

Barnett International

Quality Systems: A Controlled Approach to GCP Compliance

12:30 PM - 2:30 PM Eastern

A Quality Systems approach to establishing and maintaining regulatory compliance allows sponsors to better leverage their resources and Clinical Investigators to meet their obligations for clinical research oversight. This web seminar will review the elements of a Quality System at the Clinical Investigator site and how it functions to proactively control site-level noncompliance.

October 3, 2014

Barnett International

Data Safety Monitoring Boards (DSMBs) for Clinical Trials

9:30 AM - 11:00 AM Eastern

This web seminar will describe what a Data Safety Monitoring Board (DSMB) — also known as a Data Monitoring Committee (DMC)—is, and how it’s constituted according to FDA and European Medicines Agency (EMA) requirements. We’ll cover the selection of the members and their duties and responsibilities, as well as when a DSMB/DMC is and is not needed. We’ll also take a look at the contents of a DSMB/DMC charter. Interim analyses (with and without statistical analyses) will be discussed, as well as looking at benefits and costs. DSMB/DMC actions and recommendations in terms of study change or termination will be reviewed. Problems, ethical issues, and potential conflict will be discussed, along with strategies for resolving them. Learners will come away with tips, war stories, and practical advice on making DSMB/DMCs work.

October 3, 2014

Barnett International

Final AE Regulatory Guidance: Reporting/Communication of Safety Information from Clinical Trials to IRBs

12:00 PM - 1:30 PM Eastern

This web seminar presents content and impact discussion of the FDA and Office of Human Research Protections (OHRP) Adverse Event reporting guidance documents. The guidance documents address issues of Adverse Event information exchange between stakeholders and propose solutions to the issues of the quality of information being sent to the IRBs. The guidance impacts the activities of the research site, IRB, and sponsor/CRO’s role in compiling and/or communicating Adverse Event information during a research study, changing the industry’s current practices.

October 6, 2014

Barnett International

Use of Notes to File in Clinical Trial Essential Documentation

8:30 AM - 10:00 AM Eastern

Notes to File (NTF), also known as Memo to File, are commonly used as essential documentation in sponsor and site files. Many times the content of the NTF does not serve the purpose for use or serves no purpose at all. This web seminar will discuss the appropriate and inappropriate uses of NTF, the questions to ask to determine if NTF would be beneficial, and the components of a quality NTF, if being used.

October 6, 2014

Barnett International

Corrective Action Plans: Essential Documentation of a Site's Response to GCP Deficiencies

12:00 PM - 1:30 PM Eastern

Non-compliance at research sites requires corrective action planning to address the deficiencies. The corrective action plan should include more than just the identification of the deficiency and intervention chosen to address the issue. Effective corrective action planning includes other important components that lead to promoting improved performance for future activities: Ultimately improved human subject protections and data integrity. Lack of these components can lead to repeated non-compliance and in some cases to rejection of corrective action plans by regulatory authorities.

October 7, 2014

Barnett International

Principal Investigator Training: Roles and Responsibilities

12:00 PM - 3:00 PM Eastern

The roles and responsibilities of the Principal Investigator (PI) are essential for quality data and regulatory compliant clinical trials, but the PI remains an under-trained position in the industry. Because of the critical role the PI plays during a clinical trial, there is debate within the industry of mandatory certification for the PI and/or site accreditation. Documentation of industry training is essential. This web seminar reviews the clinical trial core competencies required for the Principal Investigator in accordance with the federal regulations, ICH GCP guidelines, and industry best practices.

October 8, 2014

Barnett International

The Fundamentals of Clinical Research Project Management

12:00 PM - 1:30 PM Eastern

Participants will explore the principles of project management and apply project management tools to ensure the success of their clinical research projects. Participants will learn to develop a project charter, a work breakdown structure, a risk assessment and contingency plan, a process improvement plan, as well as how to lead without authority. Each participant will leave the session with tools and checklists to apply to their projects.

October 8, 2014

Barnett International

Negotiation Skills for Clinical Research Professionals

3:00 PM - 4:30 PM Eastern

The ability to negotiate effectively is a core competency for all clinical research professionals. Yet many people find negotiating to be an intimidating experience. Take this interactive web seminar and dramatically improve your ability to negotiate in any situation. With specific examples and real world case studies drawn from clinical research, you will be able to immediately implement the skills you learn with ease. This web seminar will provide a rich learning experience in implementing negotiation best practices.

October 8 - December 17, 2014

Barnett International

10-Week CRA & CRC Beginner Program

6:00 PM - 9:00 PM Eastern

The online 10-Week CRA & CRC Beginner Program provides a comprehensive introduction to clinical research and the job functions of the Clinical Research Associate (CRA) and Clinical Research Coordinator (CRC) for drug, biologic, and device trials. This program is geared toward individuals seeking a new career or career change into clinical research, but haven’t decided which job track to pursue. Case studies and industry best practices are presented to emphasize how the learning objectives apply directly to the responsibilities of the CRA and CRC. Upon completion, Barnett will provide resume assistance so that you can position yourself for entry into this market.

October 9, 2014

Barnett International

Strategies for Conducting Vendor Audits

9:30 AM - 11:00 AM Eastern

Regulatory agencies hold companies accountable for delivering high quality products that meet all established requirements and specifications. Vendors play a key role in accomplishing these mandates and it is the sponsor’s responsibility to ensure their vendors meet all regulatory specifications for the supplied materials, equipment, and/or services. During this web seminar, we will discuss types of vendor audits, various methods/media to conduct vendor audits, planning for the audit, and follow-up to vendor audits.

October 9, 2014

Barnett International

Establishing a Vendor Management Program

1:00 PM - 2:30 PM Eastern

As vendor/contractor/subcontractor/supplier relationships and usage increase in use and complexity, vendor management is receiving more attention as a way for organizations to achieve a competitive advantage and make their outsourcing relationships part of their long-term success plan. However, while the benefits of vendor management programs have been widely reported, many organizations still lack the guidelines and tools to successfully implement such a program. This web seminar is designed to present techniques and best practices to establishing and monitoring a vendor management program. During the course, we will discuss the various roles and responsibilities, strategies to categorize and monitor vendors, and the benefits of a vendor management program.

October 10, 2014

Barnett International

ABCs of GCP and the 13 Principles of ICH

9:30 AM - 11:00 AM Eastern

This web seminar provides the basic concept of Good Clinical Practice (GCP). Participants will learn the goals of GCP and its common elements (FDA regulations and ICH Guidelines) defining the quality system of mutual accountability between the sponsor, investigator, IRB/IEC, and the regulatory authority. The basic roles and responsibilities of each stakeholder will be discussed in relation to these criteria. The 13 principles of ICH GCP will be discussed in a practical manner to ensure compliance with all regulatory requirements.

October 10, 2014

Barnett International

Monitoring Reports: 10 Rules of Effective Report Writing

12:00 PM - 3:00 PM Eastern

The Clinical Research Associate (CRA) creates reports that have many audiences, one being regulatory authorities reviewing essential documentation of clinical trials linked to marketing application approvals. This web seminar presents 10 categories of scientific report writing in the context of the role of the CRA and the reports that they write. The applicable reports are monitoring visit reports, e-mails, telephone reports, Memos to File, and more. The concepts of writing in a scientific voice versus first person, objective versus subjective, and many more are presented. This course is invaluable for the CRA, as well as the individual who critiques the various reports.

October 14, 2014

Barnett International

Study Site Start-Up: Organization and Management Tips for the Novice Clinical Research Site

12:00 PM - 2:30 PM Eastern

The role of the research site is vital in the success of a clinical trial. Quality research sites are in great demand in the current research environment. This web seminar presents an overview of the core components for a successful research site. Examples of successful sites for benchmarking will be included as well as resources for more information.

October 14, 2014

Barnett International

Data Quality in Clinical Trials: Rationale and Impact

12:30 PM - 2:30 PM Eastern

Good Clinical Practice (GCP) is the universal ethical and scientific quality standard for conducting clinical trials. The GCP standard applies to all aspects of the clinical trial process. Adherence to the GCP quality standard during the clinical trial process provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of the trial subjects are protected.

October 15, 2014

Barnett International

Pediatric Clinical Drug Development

12:30 PM - 3:30 PM Eastern

Fueled by the encouragement from regulatory agencies in the U.S. and Europe, the art and science of pediatric drug development has evolved rapidly in pharmaceutical companies over the last few years. Due to recent governmental initiatives such as the Pediatric Research Equity Act (PREA) in the U.S. and Pediatric Investigation Plans (PIPs) in Europe, pharmaceutical companies have been given clear pathways and incentives to develop drug indications and products for this important group of patients. This web seminar will examine these regulatory initiatives and discuss practical and effective development approaches and study designs.

October 16, 2014

Barnett International

Warning Letters: Applying Lessons Learned from Misbranding and Adulteration Noncompliance Findings

1:00 PM - 2:30 PM Eastern

In this web seminar, we will focus on common themes such as misbranding and adulteration found in warning letters issued by the FDA to pharmaceutical, medical device, and biotechnology companies. Specifically we will review the concepts of misbranding and adulteration in detail, and provide examples of where compliance issues commonly arise in these areas. We will discuss best practices for responding to warning letters, as well as strategies that can be implemented to help avoid them. Whether you are new to the warning letter experience or you are working on issues in response to one, you will find this webinar useful.

October 17, 2014

Barnett International

Trial Master File (TMF) for Sponsors: Set Up and Maintenance

12:00 PM - 2:00 PM Eastern

The Trial Master File (TMF) is a collection of the essential documents for a sponsor to record how they have fulfilled their obligations as sponsor for a clinical trial project. This web seminar reviews the sponsor TMF required and additional content for a clinical trial. The activities of set-up, maintenance, and quality control and assurance will be discussed along with common deficiencies and challenges. This course will also include handouts and discussion of the TMF Reference Model.

October 21, 2014

Barnett International

Writing and Updating the Investigator's Brochure

12:00 PM - 3:00 PM Eastern

During the course of clinical research, the Investigator’s Brochure (IB) is the data repository for an investigational product; effectively this is the product’s “label” during the investigational stage. The IB is a dynamic document which changes as the information changes. It is critical in clinical research as physicians and Institutional Review Boards (IRBs) refer to the IB on an ongoing basis to answer questions about Serious Adverse Events, Adverse Events, dosing, manufacturing, and clinical and nonclinical study results.