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Webinars

October | November | December |

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.

November

November 14, 2014 - February 20, 2015

Barnett International

10-Week CRA & CRC Beginner Program

8:30 AM - 11:30 AM 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.

November 21, 2014

Barnett International

Study Feasibility: Eliminating Low and Late Enrollment

12:30 PM - 2:30 PM Eastern

This web seminar is designed for sponsor/CRO personnel responsible for protocol design and development, country allocation, site selection, and study feasibility assessments. The current study feasibility assessment process is inefficient and is incapable of identifying the best investigative sites to conduct a clinical trial. Feasibility questionnaires and the current process are often not effective in predicting site success in implementing a given clinical trial. This session will explore novel approaches and technologies that can be used to significantly improve the feasibility assessment process at the protocol, country, and site level.

November 24, 2014

Barnett International

ABCs of Clinical Research for Clinical Administrative Support Staff

9:00 AM - 11:30 AM Eastern

This course provides the background needed to become an integral part of the clinical research team (for drugs and devices) and explores the need to understand the rationale behind quality performance and team-playing. The roles and responsibilities of Clinical Administrative Support will be discussed in terms of obligations to the study team and the importance of compliance with Standard Operating Procedures and Standard Office Practices. Although the course is designed for administrative staff with less than one year experience, those with some experience may also find this course helpful in providing the rationale for doing tasks in a specific manner, refining their skills, and sharing their experiences and helpful techniques with their colleagues.

November 24, 2014

Barnett International

Preparing Clinical Research Sites for FDA Inspections

12:00 PM - 2:30 PM Eastern

This web seminar is designed for participants that are sponsors/CROs and research site representatives preparing for a research site FDA inspection. From audit readiness to action item resolution, each site faces its own unique challenges. This course will prepare you and your site for expectations from the FDA and provide concrete steps you can take to prepare before, during and after the inspection.

November 25, 2014

Barnett International

Establishing a Risk Management Framework for Clinical Trial Conduct and Oversight

9:30 AM - 11:00 AM Eastern

As many organizations move to, or contemplate, a risk-based approach to trial conduct and quality management, the published regulatory agency documents and industry think tank publications fall short in providing sponsors, CROs, and clinical vendors the framework—a comprehensive, systematic, structured approach to implementing risk management. This web seminar will provide an overview of a risk management reference model for use that has been adopted by other industries and is referenced in the FDA Guidance of 2013, “Oversight of Clinical Investigations — A Risk- Based Approach to Monitoring.”

November 25, 2014

Barnett International

Root Cause Analysis: Applying the Concept for Better Study Compliance Management

12:00 PM - 2:30 PM Eastern

Managing compliance in the research industry is vital to successful clinical trials. Regulatory authorities expect that all stakeholders identify non-compliance, intervene, and then evaluate the effectiveness of the intervention. Without root cause analysis, interventions cannot be effectively identified and designed. This web seminar will present the scientific concepts of root cause analysis and apply them specifically in the clinical trial setting. Root cause analysis is invaluable for all stakeholders in clinical research, the sponsor, CRO, site, and Institutional Review Board (IRB).

December

December 1, 2014

Barnett International

Risk-Proof Your Sites: Monitoring Strategies for Managing Risks

9:00 AM - 11:00 AM Eastern

The concepts and processes of risk management are well known and often used in clinical research project management. Yet, few clinical research monitors realize the value of applying these activities to site management. This web seminar starts with an overview of risk assessment and management. The learner is then guided through the application of these techniques through all phases of study conduct: Site selection and initiation, routine monitoring, and site close-out. The course focuses on identification of site strengths and weaknesses and implementing strategies to address weaknesses before they lead to deviations or noncompliance.

December 1, 2014

Barnett International

Cases in Advanced GCP: A Problem-Solving Practicum

12:00 PM - 3:00 PM Eastern

This application-based web seminar covers advanced concepts and challenges encountered in the application of Good Clinical Practice (GCP). During this highly interactive course, participants will review and discuss cases that include GCP challenges in topic areas such as IRB/IEC approval, informed consent, drug accountability and reconciliation, SUSAR submissions, communications with ethics committees and health authorities, as well as the management of investigational product. Cases are based on actual industry examples, and participants are expected to solve cases by applying Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) principles, which are briefly reviewed.

December 1, 2014

Barnett International

Risk-Based Monitoring for Sites: Prepare Your Site for Success

1:00 PM - 2:30 PM Eastern

Over the past few years, a new term has emerged in the clinical research industry: Risk-Based Monitoring (RBM). What is it? Why is it becoming more widely used? How does it impact Investigators and sites? This web seminar will provide an overview of the principles of RBM and describe how this new approach to monitoring differs from “traditional” monitoring. Learners will gain an understanding of both regulatory and industry factors influencing the adoption of Risk-Based Monitoring. This web seminar will help participants anticipate the possible changes brought on by RBM, and provide strategies to prepare their sites for success.

December 2 - December 18, 2014

Barnett International

30-Hour Clinical Project Management Fundamentals Certificate Program

9:00 AM - 12:00 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.

December 2, 2014

Barnett International

CRO Partnership Management

1:00 PM - 2:30 PM Eastern

In an environment where we are outsourcing multiple tasks, it is valuable to understand the dynamics of relationship building and the application of practical management. Extensive knowledge and skill are required to manage large teams, especially when the majority of the team functions outside of your organization. This web seminar provides an overview of Contract Research Organization (CRO) partnership building, management, application of root cause analysis (RCA) and strategies for problem solving.

December 3, 2014

Barnett International

Sponsor Management of Investigator Non-Compliance

12:00 PM - 2:00 PM Eastern

Investigator non-compliance to the Statement of Investigator commitments has increased in many areas. One of the identified causes has been monitoring. Investigator compliance issues are great risks to product development success, but an even greater risk to sponsors is the lack of formal systems to manage compliance at research sites. With the promise of more sponsor inspections, the sponsor management of investigator noncompliance is an obligation that requires comprehensive management approaches that lead to control of investigational product, data integrity, and adequate documentation for regulatory inspection of sponsors monitoring programs and/or investigative sites. Seven steps in compliance management of research sites will be presented for the participants to assess their current practices for gaps and risks for preparing for potential regulatory inspection evaluating compliance management of research sites.

December 4, 2014

Barnett International

SOP Writing: How to Create, Implement, and Maintain User-Friendly SOPs Workshop

9:00 AM - 4:00 PM Eastern

In the world of clinical research, it would be difficult to find someone who hasn’t heard of Standard Operating Procedures (SOPs). Yet there remains great mystery in how to create an SOP.

December 4, 2014

Barnett International

Regulatory Intelligence

12:00 PM - 1:30 PM Eastern

The constantly changing regulatory environment necessitates keeping abreast of current information from a variety of sources. Regulatory Intelligence (RI) is the act of gathering and analyzing regulatory information for impact or changes in laws, regulations, directives, guidance documents, etc. There is more to RI than keeping up with the latest regulations and guidelines. Regulatory precedence, industry practices, regulatory agency opinions, and competitor information are just a few of the valuable sources of information that can help regulatory affairs professionals to develop successful regulatory strategies.

December 4, 2014

Barnett International

Improving Readability of SOPs and Other Procedural Documents

2:15 PM - 4:15 PM Eastern

No one really likes reading SOPs. Whether this is a true “necessary evil” or not, this, in itself, makes it important that the associated pain is minimized. More often than not, the contents of the SOPs are simply “tossed” into a document with little ado. Such an approach perpetuates a vicious circle: First, the user, not being able to fully comprehend what they are reading, simply stops reading; then, authors, knowing the document won’t be read, don’t put effort into writing it. The by-product of these events is that compliance suffers. Fortunately, there is a way to break out of this circle: (1) develop documents that SOP users can understand; and (2) present the contents in an easy to view way. Regardless of the content, the better its presentation, the more likely the document is to be read and used.

December 5, 2014 - February 20, 2015

Barnett International

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

12:00 PM - 3:00 PM 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.

December 5, 2014

Barnett International

ABCs of GCP and the 13 Principles of ICH

1:00 PM - 2:30 PM 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.

December 8, 2014

Barnett International

How to Write Effective Monitoring Reports and Communications Workshop

9:00 AM - 4:00 PM Eastern

Clinical Monitors (CRAs) must document many details of the happenings at investigational sites, including Confirmation Letters to sites, Monitoring Visit Reports, Follow-Up Letters to sites, Telephone Contact Reports, Email/Faxes to sites, and Queries and Notes to File (NTF). All of these become essential documents as they demonstrate the compliance of the monitor and, thus, the sponsor in the conduct of the clinical trial.

December 8, 2014

Barnett International

Electronic Source Data in Clinical Investigations: Navigating the Final FDA Guidance

9:30 AM - 11:30 AM Eastern

As the use of electronic source documentation (eSource) increases, so does the scrutiny for ensuring the integrity of the systems used to generate and retain electronic source data. In late 2010, the FDA issued a draft guidance regarding the use of eSource, providing direction on capturing, using, and archiving electronic data in FDA-regulated clinical investigations. A final guidance was released in September 2013 focusing on identification and specification of authorized source data originators, the creation of data element identifiers to facilitate examination of the data audit trail, capture of source data into the eCRF, and Investigator responsibilities. This web seminar will review how the requirements for paper source documentation translate to the electronic source document as well as examine real-world examples of the FDA’s review of eSource.

December 8, 2014

Barnett International

Auditing Clinical Research Studies: An Overview for Assessing GCP Compliance

12:30 PM - 2:30 PM Eastern

Quality assurance is defined as a “systematic and independent examination of trial-related activities and documents” that allows an auditor to determine whether or not the clinical trial was conducted according to the regulations and guidance that govern clinical research. This web seminar will provide an overview of auditing skills and techniques and a review of recent GCP audit findings from Clinical Investigators (Sites), Sponsors, and Institutional Review Boards (IRBs).

December 9, 2014

Barnett International

Risk-Based Auditing: Effective Compliance Strategies

9:30 AM - 11:30 AM Eastern

An audit is defined as a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, the sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). Auditing focuses on the systems that generate this data, whereas monitoring tends to focus primarily on the data. Risk-based approaches to auditing, such as focusing on the most critical data elements, are more likely to ensure subject protection and overall study quality, and will permit sponsors to focus their compliance efforts more effectively. This web seminar will provide an overview of risk-based auditing skills and techniques, and a review of recent GCP audit findings from Clinical Investigators (sites), sponsors, and Institutional Review Boards (IRBs).

December 9, 2014

Barnett International

Quality Risk Management in Clinical Trials and Pharmacovigilance

12:00 PM - 1:30 PM Eastern

The ICH Q9 Quality Risk Management (QRM) guideline has become an accepted standard, facilitating the development and implementation of a systematic risk-based approach to quality management of clinical trials and pharmacovigilance. Industry and regulatory bodies, including the EMA and FDA, have recognized the need and benefits of implementing a risk-based approach to quality management.

December 9, 2014

Barnett International

Good Clinical Practice: Practical Application and Implementation

12:30 PM - 2:30 PM 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.

December 10, 2014

Barnett International

Understanding Global Requirements for Trial Registration and Disclosure of Results

1:00 PM - 2:30 PM Eastern

Since its inception in 2000, the clinical trials registry has served as a source of information for the general public, academia, and industry. In 2007, the U.S. Congress passed FDAAA, which required additional trial registration information, more types of trials to be registered, and the submission of summary results for applicable clinical trials. The following year, sponsors and Principal Investigators began submitting the results of clinical studies on ClinicalTrials.gov. Although submission of Adverse Event information was optional when the results database was released, it became required in September 2009.

December 10, 2014

Barnett International

State Laws Governing Clinical Trial Regulatory Compliance

1:00 PM - 2:30 PM Eastern

Although many clinical trial sponsors and investigators focus primarily on FDA regulations related to the conduct and design of clinical trials, their failure to comply with state laws and regulations may expose sponsors, investigators, IRBs, institutions, or individuals may call into question the potential integrity of clinical data. Today’s U.S.-based clinical trials must meet not just federal requirements, but an increasingly complex array of state-specific requirements, many of which are critical and foundational to clinical studies.

December 11, 2014

Barnett International

Risk-Based Thinking: How Monitors Can Develop an Auditor's Perspective

9:30 AM - 11:00 AM Eastern

The regulations require that sponsors ensure the selection of qualified monitors and the proper monitoring of clinical investigations. However, sponsors are frequently cited by the FDA for failure to meet those requirements. These regulatory communications note that although monitors might have identified issues, they did not appreciate the significance of those findings. As a result, opportunities to promptly secure compliance might be missed.

December 11, 2014

Barnett International

Clinical Trials and the Sunshine Act: The Effect on the Clinical Research Industry

1:00 PM - 2:30 PM Eastern

In an effort to increase transparency, highlight potential conflicts of interest, and ultimately decrease healthcare costs, one element of the Patient Protection and Affordable Care Act (PPACA) – the Sunshine Act – requires disclosure of payments or transfer of value to physicians. These physicians can also be involved in clinical research as Investigators, in which case additional information is required to be reported. Released in February 2013, the final rule requires applicable manufacturers of covered drugs, devices, and biological supplies to gather and report information to be listed on the public website. This web seminar will address the requirements for reporting of information derived from clinical research as well as exceptions for reporting.

December 11, 2014

Barnett International

Auditor Emotional Intelligence

1:00 PM - 3:00 PM Eastern

Audits are often viewed as transactional and factual – and rightly so! They are transactional (a process carried out) and must be factual, devoid of as much personal bias and emotion as possible. However, the power of advanced soft skills in enhancing both the transactional and factual aspects of an audit cannot be underestimated. We have all heard stories of painful audits with auditors who possessed little to no soft skills. The use of appropriate, advanced soft skills serves to reinforce a culture of quality with the auditee. The most important soft skill a quality professional can possess is emotional intelligence.

December 12, 2014

Barnett International

Recent Trends in Noncompliance: Critical Review and Analysis of Recent Regulatory Letters and Communications from the FDA, EMA, and Health Canada

9:30 AM - 11:30 AM Eastern

As the clinical research environment evolves in response to both internal and external changes, regulatory agency communication appears to be focused on particular areas of GCP compliance. Regulatory agencies’ recent findings for Clinical Investigators, sponsors, and Institutional Review Boards (IRBs) tend to reflect historic areas of noncompliance; however, more attention is being placed on ensuring that corrective and preventive action plans are developed to secure compliance. This web seminar will examine the trends in recent regulatory communication and open discussion for review of acceptable versus unacceptable responses.

December 12, 2014

Barnett International

Auditing Sponsors and CROs: Deconstruction and Application of the FDA's Compliance Program Guidance Manual

12:30 PM - 2:30 PM Eastern

As scrutiny of sponsors, Contract Research Organizations (CROs), and monitors involved in the conduct of clinical research intensifies, companies are using their quality assurance resources to review internal (and vendor) systems to ensure compliance within a changing regulatory environment. A systematic application of the Compliance Program Guidance Manual (CPGM) permits identification of regulatory risks during qualification and in-process audits. This web seminar will review the FDA’s current guideline for conducting inspections and how to apply them to assess Quality Systems. Assessment of the SOPs that are expected for sponsors and CROs, including registration of trials and informed consent document issues, will also be discussed.

December 15, 2014

Barnett International

Monitoring Reports: 10 Rules of Effective Report Writing

8:30 AM - 11:30 AM 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.

December 15, 2014

Barnett International

Investigator Initiated Trials: Roles and Responsibilities

12:00 PM - 2:00 PM Eastern

Investigator Initiated Trials (IITs), also referred to as Sponsor-Investigator (SI) Trials are increasing in popularity. A Sponsor-Investigator is anyone who functions as the Clinical Investigator (CI) of a given study and who also holds the investigational marketing application, i.e., the IND or IDE. How does the CI ensure compliance to both the investigator and sponsor responsibilities? This web seminar will present the responsibilities, discuss risk, and provide suggestions for compliance.

December 16, 2014

Barnett International

Trial Master Files: Why They Are Important and How to Organize Them Workshop

9:00 AM - 4:00 PM Eastern

The Trial Master File is a collection of the essential documents for a sponsor to record how they have fulfilled their obligations for a clinical trial. The Code of Federal Regulations states in 21 CFR 312.50 that, “Sponsors are responsible for… ensuring that the investigation(s) is conducted in accordance with the general investigational plan and protocols contained in the IND.” The European Directive 2005/28/EC states that, “the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.” ICH GCP, Section 8.1 defines these essential documents as those that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.