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Webinars

August | September | October | November |

August

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.

October

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 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.

October 22, 2014

Barnett International

HIPAA Team Training: Fundamental Training Specifically for Clinical Research Setting

12:00 PM - 3:00 PM Eastern

HIPAA Team Training has been designed as a course presenting concepts and terminology of HIPAA specific to conducting clinical trials. The web seminar presents the core elements with methodologies for blending the concepts into established clinical trial best practices. The focus of the course is to train sponsors/CROs and site clinical researchers HIPAA concepts for later application in day-to-day roles.

October 23, 2014

Barnett International

Writing Clinical Study Reports for Diagnostic Studies

12:00 PM - 1:30 PM Eastern

Diagnostic studies vary greatly from standard pharma and device studies, and the documents generated for these studies differ accordingly. This web seminar presents the basic tools required to generate Clinical Study Reports (CSRs) for sample collection, accuracy, and reproducibility studies. Participants will learn the elements of each of these CSRs, the guidances to follow for reference, basic skills for understanding the data (i.e., false positives, false negatives, and percent agreement), and other diagnostics output and results, as well as coordination with the 510(k) submission.

October 23, 2014

Barnett International

The IND in a CTD/eCTD Format

2:30 PM - 4:00 PM Eastern

The Common Technical Document (CTD) format is now the required format for all marketing applications in the U.S., EU, Japan, Canada, and Australia. Clinical Trial Applications (CTAs), the required format of INDs in most countries, are required to be in the CTD format. Currently, the U.S. does not require INDs to be in the CTD format, but rather the traditional format (per regulations in 21 CRF 312.23). However, since all marketing applications are required in the CTD format, it is more efficient to start the IND in the CTD format. If you use the traditional format, the IND and all amendment information must be converted to the CTD format prior to marketing application submission. This conversion time can impact the timeline for marketing application submission, so why not plan ahead for a successful marketing application and start the IND in the CTD format?

October 24, 2014

Barnett International

Phase I Study Management

1:00 PM - 2:30 PM Eastern

Because the early life of a compound is dependent on the data and analysis derived from Phase I Studies, it is imperative that these trials are managed and conducted with the highest quality and care. Therefore, well-honed project management skills that can address the unique issues associated with Phase I Studies are needed. This web seminar will examine the importance of Phase I Studies in drug development, the issues commonly associated with conducting a Phase I Study from a sponsor perspective and provide project management best practices specific to overseeing a Phase I Study.

October 27, 2014

Barnett International

Monitoring Medical Device Trials: An Introduction

9:30 AM - 11:00 AM Eastern

This web seminar will provide the core concepts involved in monitoring medical device studies, including activities conducted at the investigator site, communication between monitor visits, and monitoring with centralized systems. We will explore the monitoring concepts as provided by the FDA in the Risk-Based Monitoring Guidance of 2013, as well as the ICH as interpreted for medical device trials. The basics of clinical monitoring and appropriate documentation to support adequate oversight of the study will be covered. Sponsor responsibilities and the role of the Clinical Research Associate/Monitor will be explored.

October 27, 2014

Barnett International

Design Considerations for GCP Training Programs

1:00 PM - 3:00 PM Eastern

Regulatory authority inspection trends are identifying a need for truly effective Good Clinical Practice (GCP) training. GCP training should ensure that clinical research stakeholders not only “know GCP” but know how to apply the principles of GCP in their work lives. The decision to develop and implement a GCP Training Program is a time-consuming and expensive project for any clinical research organization. How can you maximize the effectiveness of the training to ensure return on this investment in both financial and compliance terms? By designing GCP training with a focus on engaging adult learners, which is critical to ensuring both acceptance by the learners and the transfer of knowledge into everyday professional practice. This web seminar will identify key elements to consider throughout the phases of program development and design, training deployment, and post-course assessment.

October 28, 2014

Barnett International

Managing CRAs to Improve Study Outcomes

12:00 PM - 2:30 PM Eastern

Monitoring a clinical trial is a required activity completed by sponsors of FDA regulated research that significantly affects the outcomes of product development and approval. Effectively managing the performance of Clinical Research Associates (CRAs) by sponsors is essential. Performance Management and Improvement is a science involving logical processes and applications. This web seminar will present the concepts of the Human Performance Improvement (HPI) Model and apply it directly to the management of the CRA to promote improvements. The HPI CRA Management Model will be presented and applied via case scenarios for better understanding.

October 28, 2014

Barnett International

Writing Protocols for Diagnostic Studies

2:30 PM - 4:00 PM Eastern

Diagnostic studies vary greatly from standard pharma and device studies, and the documents generated for these studies differ accordingly. This web seminar presents the basic tools required to generate protocols for sample collection, accuracy, and reproducibility studies. Participants will learn the elements of each of these protocols, how they differ from the standard pharma protocols, the guidances to follow for reference, and the regulatory environment surrounding sample collection and informed consents for de-linked samples.

October 29, 2014

Barnett International

Writing the Clinical Study Report

12:00 PM - 3:00 PM Eastern

The Clinical Study Report (CSR) is a critical document in the drug development and regulatory submission process. This web seminar presents the basic tools required to generate CSRs for the pharmaceutical industry. Participants will learn the elements of the CSR and the appendices, methods for turning the protocol and statistical outputs into one cohesive document, the basics of writing and preparing a document for submission, and the guidances to follow for reference.

October 29, 2014

Barnett International

Updates in Informed Consent Guidance

12:00 PM - 1:30 PM Eastern

Conducting the informed consent process is one of the most critical tasks to be completed by a research site. It is essential that a subject clearly understand the language in the consent form and that their rights, safety and welfare are not jeopardized in any way. In this web seminar, we will look at the essential language in the informed consent document through review of the FDA regulations and guidance documents, including the “Guidance on Exculpatory Language in Informed Consent” and additional regulatory updates and considerations.

October 31, 2014

Barnett International

Adverse Event Monitoring for CRAs

12:00 PM - 2:00 PM Eastern

During monitoring visits, one of the most important and impacting activities that a Clinical Research Associate (CRA) performs is the source document verification of Adverse Events (AEs). The CRA serves as the eyes for the research sponsor when it comes to proper collection and documentation of subject safety information. Incorrect and inadequate monitoring of AEs can lead to inaccurate labeling for clinical trials and impact market application inspectional reviews, as well as post marketing labeling. The safety, regulatory, and ICH definitions will be reviewed and applied to the monitoring process in this web seminar. This includes Causality, Expectedness/Unanticipated, and other important concepts. Case scenarios will be used to apply the information for better learning.

November

November 3, 2014

Barnett International

The GCPs of Essential Documents

9:30 AM - 11:00 AM Eastern

Understanding the big picture of how essential study documents impact the approval and ethics of a clinical research trial often gets overlooked in the rush of document collection and requests. The foundation of this web seminar is the site study file, what the documents are, and why they are important as related to ICH GCP E6 Essential Documents and 21 CFR 50, 54, 56 and 312. This web seminar will also provide a reference point for why the paperwork is so critical within the process of a study.

November 3, 2014

Barnett International

Use of Notes to File in Clinical Trial Essential Documentation

12:00 PM - 1:30 PM 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.

November 3, 2014

Barnett International

Leading Teams in a Changing Clinical Research Environment

12:30 PM - 2:30 PM Eastern

Teams have become much more complex in the past 10 years. In the past, a team would be comprised of similar individuals in the same location driving on a fairly stable course towards its objectives. These tenets are no longer true. Trends are driving the need for more flexible, highly skilled teams.

November 4, 2014

Barnett International

Ensuring Success Through Smarter Site Selection and Study Feasibility

9:30 AM - 11:00 AM Eastern

Site selection is a complex dance between sponsors and sites. The wrong choice can have serious consequences, impacting quality, time, and finances for both the sponsor and investigator. In this web seminar, the steps for site selection and study feasibility will be discussed. Sponsors will learn the most critical questions to ask an investigator and staff to ensure quality and timely data as well as appropriate enrollment. Sites will learn how they can be proactive in the selection process and how to ensure the study is feasible.

November 4, 2014

Barnett International

Writing Clinical Study Protocols

12:00 PM - 3:00 PM Eastern

The basis and success of any drug or device development program is the clinical trial protocol. Clinical trials conducted under an IND or IDE cannot begin without a protocol, and yet there is variability between companies and individuals on how to approach writing this critical document. Clinical trials and entire programs have failed because the protocol was not scientifically sound. Knowing how to effectively research and write a clinical trial protocol is essential to a compound achieving IRB and market approval.

November 5, 2014

Barnett International

Current FDA and EMA Inspection Findings: Lessons Learned

1:00 PM - 2:30 PM Eastern

Failure to follow the investigational plan, inadequate Principal Investigator (PI) oversight, and informed consent irregularities remain high on the list of leading findings in U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) inspections. In this web seminar, we will examine real-world examples from the current top inspection findings, and discuss appropriate corrective and preventative actions (CAPAs), equipping learners with solutions to avoid common pitfalls and ultimately avoid inspection findings in the future. Correct conduct according to GCP will be discussed and lessons learned applied to help prevent these findings from occurring again. Learners are encouraged to share their experiences as participants discuss methods and tools to aid in compliance through appropriate techniques for ICH-GCP compliance. Tools will be provided to assist clinical research personnel in their efforts to be ICH-GCP compliant.

November 6, 2014

Barnett International

Managing Observational Studies

12:00 PM - 1:30 PM Eastern

Observational studies in the biopharmaceutical and medical device industries encompass various designs and purposes, including post-approval safety studies, product or disease registries, pregnancy registries, medical chart reviews, and cohort studies. This web seminar offers practical approaches to the management of observational studies, focusing on issues and aspects that occur commonly, differ from clinical trial management, and are key to program success. Topics to be addressed include project oversight, ethics/Institutional Review Board (IRB) approvals, data quality management, site and subject recruitment and retention, and protocol adherence.

November 7, 2014

Barnett International

Monitoring Phase I Clinical Trials

12:00 PM - 2:00 PM Eastern

Phase I trials require an additional monitoring skill set. The Clinical Research Associate (CRA) assessment focus changes in many monitoring practices, from the Informed Consent Form to data review of PK sampling. Most CRA trainings do not test or provide practicum for the unique focus of a Phase I trial. This web seminar will identify the differences in skills and review specific components for monitoring studies in this phase of research. References from GCP to support monitoring activities will be presented, as well as case studies to apply presented concepts.

November 10, 2014

Barnett International

Case Report Form Design, Strategy, and Standards Workshop

9:00 AM - 4:00 PM Eastern

According to the Society for Clinical Data Management (SCDM) Good Clinical Data Management Practices (GCDMP): “…no document in a clinical trial (other than the study protocol) is more important than the instrument designed and used to acquire data. The quality of the data collected relies first and foremost on the quality of this instrument. Regardless of the time and effort spent conducting the trial, the correct data points must be collected; otherwise, a meaningful analysis of the study’s outcome may not be possible. Therefore, it follows that the design, development, and quality assurance of such an instrument must receive the utmost attention.”

November 10, 2014

Barnett International

GCP Training for Investigators

12:30 PM - 3:30 PM Eastern

This web seminar provides a brief review of new drug development and the clinical trial process as it affects the investigator, and explains where Good Clinical Practice (GCP) fits in. Relevant sections of the Code of Federal Regulations (CFR), International Conference on Harmonization (ICH), and Form FDA 1572 are discussed in-depth and in relationship to the investigator’s responsibilities for proper conduct of clinical trials. This course will highlight the 13 principles of ICH GCP as the foundation for all clinical studies, and demonstrate to the investigator the rationale for sponsor requirements throughout clinical development of an investigational drug.

November 11, 2014

Barnett International

Study Initiation Strategies for Sponsors: Study and Site Start-Up

9:30 AM - 11:00 AM Eastern

Study start-up and initiation is one of the busiest times in the research study process. As sponsors and Contract Research Organizations (CROs) are faced with a tight timeline to get all sites up and running — critical elements of the training and communication process are often overlooked. This web seminar will focus on the steps that need to be taken to ensure start-up success at both the sponsor and site level, allow for proactive preparation, reduce the study learning curve, and eliminate study deviations and errors.

November 11, 2014

Barnett International

Implications of the FDA Guidance for a Risk-Based Approach to Monitoring

12:00 PM - 1:30 PM Eastern

The FDA’s Guidance for the Monitoring of Clinical Investigations (1988-2010) has been removed from the FDA list of guidance documents. Instead, the FDA has released an updated version of the Bioresearch Monitoring (BIMO) Compliance Program Guidance Manual for Sponsor/CRO and Monitoring. In August 2013, the agency issued a final guidance to reflect their expectations and recommendations related to monitoring investigation sites, monitoring systems, and investigative site oversight. In this web seminar, the content and the implications to sponsor monitoring and clinical investigation sites will be discussed.