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Webinars

August | September |

June 6 - August 22, 2014 (Fridays)

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.

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.

August 19, 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.

August 21, 2014

Barnett International

Case Report Form Design, Strategy, and Standards

9:30 AM - 11:30 AM Eastern

The phrase "garbage in, garbage out" can be applied to the data collection efforts in clinical trials. To avoid this pitfall, it’s important to be thorough in the evaluation of the data collection items that will validate the protocol hypothesis endpoints and statistical analysis. It’s also important to consider the future compilation of data from multiple clinical trials for agency submission and the assurance that the data are in compatible format. With this goal in mind, it’s essential for data collection to be consistent, concise and compatible – hence the need for standards. CDISC and CDASH are instrumental in the establishment of these standards. This web seminar will discuss the timing of Case Report Form (CRF) design in relation to clinical trial startup and the team that will contribute to the data collection recommendations. We will review the resources utilized in determining what data collection is required and the current standards – CDISC and CDASH – for CRF data content. Best practices for CRF design as documented by the Society for Clinical Data Management Good Clinical Data Management Practices (SCDM GCDMP) will also be presented.

August 22, 2014

Barnett International

Social Media in Clinical Research: Effective, Innovative, and Compliant Applications

1:00 PM - 3:00 PM Eastern

The use of social media in all aspects of the research enterprise has grown exponentially. Researchers from across disciplines and institutional types are finding innovative ways to facilitate research, from online recruitment mechanisms to informed consent portals. Concurrently, researchers and their ethics review boards have been grappling with ethical and regulatory challenges as technologies continue to change rapidly, resulting in a flurry of new questions: Can I use social media to find “lost to follow up” subjects? Can I join a support group to find subjects? What regulations exist around the use of social media? Just what is public information? This web seminar will provide an overview of Institutional Review Board (IRB) considerations of social media in research, including those major ethical challenges and data security issues that may arise with the use of social media for recruitment, consent processes, data collection, and data dissemination.

August 25, 2014

Barnett International

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

9:00 AM - 10:30 AM 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.

August 25, 2014

Barnett International

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

1:00 PM - 2:30 PM 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.

August 26, 2014

Barnett International

The CRA Role in Risk-Based Monitoring: Strategies for Effective Remote Monitoring

9:30 AM - 11:00 AM Eastern

Strategies for saving time and money, without compromising oversight and quality, are an ongoing challenge within the industry. In an age where technology is ever present from ordering medications online, consulting with a physician, and having “live” conversations in chat rooms about medical issues, the clinical research industry has been slow to maximize the use of technology. With sponsors/CROs implementing the FDA’s final guidance on a risk-based approach to monitoring, time on site is being reduced to one day visits and/or on-site visits are scheduled few and far between per monitoring plans. Better utilization of remote monitoring is critical to ensure sites are compliant and the data is accurate and consistent. During this web seminar, strategies for remote monitoring will be discussed, including the review of data for trends, how to make the most of writing queries, and what “red flags” to look for that may indicate issues on site.

August 26, 2014

Barnett International

Drug Development and FDA Regulations

12:30 PM - 3:30 PM Eastern

This web seminar provides an overview of the drug development process. Included are the Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP) regulations and how they interact in the drug development process.

August 26, 2014

Barnett International

Building Relationships with Clinical Research Sites

1:00 PM - 2:30 PM Eastern

Relationships between sites and sponsors are often strained, and poor communication can interfere with having a productive study. Sites are contacted by multiple personnel during the study start-up process, and perhaps even during the study. By focusing on building relationships with the sites, the delays and errors in the startup and ongoing study process can be avoided. It is critical that the individuals working with the sites are in a position through training, knowledge, and support to positively reflect the sponsor and to ensure there is no gap in communication. This web seminar will focus on a variety of techniques for clinical study teams to use in building stronger relationships with the sites. Real-life scenarios and problem solving techniques will be discussed based on what can appear to be unreasonable monitor and sponsor requests to the site research staff.

August 27, 2014

Barnett International

Subject Recruitment: Proactive Project Plans and Issues Management

12:00 PM - 2:00 PM Eastern

This web seminar presents an overview of the patient recruitment arena, and focuses on strategies for successful clinical trials including: Systematic protocol feasibility, pre-screening approaches, insourcing and outsourcing options, and social media considerations. Included in the program are discussions for handling tough populations and the ethics of participant recruitment in clinical trials.

August 28, 2014

Barnett International

Monitoring Oncology Clinical Trials

9:30 AM - 11:30 AM Eastern

This web seminar will provide attendees with a general overview of oncology clinical trials and their distinct characteristics. We will review how oncology clinical trials differ from those in other therapeutic areas, with a special emphasis on the unique challenges of monitoring oncology clinical trials. Distinctions will be drawn between early and later phase trials. Attention will be paid to Adverse Event (AE) and Serious Adverse Event (SAE) reporting. All aspects of oncology clinical trials and how to successfully monitor them will also be discussed.

August 28, 2014

Barnett International

RECIST 1.0 and 1.1: Overview and Data Challenges in Oncology Clinical Trials

1:00 PM - 3:00 PM Eastern

RECIST stands for Response Evaluation Criteria in Solid Tumors. The National Cancer Institute is the best resource for information, and defines RECIST criteria as “a voluntary, international standard, and not an NCI standard. They are based on a simplification of former methods (WHO, ECOG) and based on measurable disease, i.e., the presence of at least one measurable lesion.” RECIST criteria provide a way to standardize measurement of solid tumors worldwide for any clinical trials that include this data to define study endpoints.

August 29, 2014

Barnett International

Case Narrative Writing for Reporting Adverse Events

9:30 AM - 11:00 AM Eastern

A narrative is a short document that is required by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to briefly describe the events in the life of a patient. These narratives are required when a patient enrolled in a study, after taking the study medication or approved drugs (post-marketing), has discontinued the study because of an adverse event, had one or more serious adverse events, or died. FDA, EMA, and International Conference on Harmonization (ICH) guidance documents call for the submission of a study subject’s experience in narrative form for those who meet these specific criteria. This web seminar will provide a set of guidelines, instructions, and templates for the writing of clinical and post-marketing case narratives for reporting adverse events.

August 29, 2014

Barnett International

Using Data to Identify Risk Indicators in Risk-Based Monitoring

9:30 AM - 11:00 AM Eastern

This web seminar will provide centralized monitoring techniques for prioritizing sites and patients in need of on-site monitoring and education. These techniques are useful when using either a risk-based monitoring approach or 100% Source Data Verification, and include both a priori “risk indicators” and dynamic error detection during study execution. Emphasis will be placed on how monitors, data managers, and statisticians can work together to prioritize the data at highest risk of causing problems and prevent errors in the database. Novel techniques for identifying fraudulent data will also be addressed. When monitors, data managers, and statisticians apply these techniques, they will be able to implement a successful risk-based monitoring plan that is practical and cost-effective, while improving the overall quality of the data.

September

September 3, 2014

Barnett International

Improving Readability of SOPs and Other Procedural Documents

12:15 PM - 2:15 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.

September 4, 2014

Barnett International

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

8:30 AM - 10:30 AM 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.

September 4, 2014

Barnett International

Introduction to Data Management

9:30 AM - 11:30 AM Eastern

This web seminar provides an excellent introduction to clinical research data management, focusing on processes and their rationale, making it ideal for the new data manager and other individuals who wish to learn basic clinical data management functions.

September 4, 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.

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 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. These are all eligible for inspection by the regulatory authorities at any time both during and after the study is completed and submitted for product approval. This is the same regulation for drugs, biologics, and devices. Effective writing skills are, therefore, extremely important so that we show the diligence and detail involved in effective monitoring. Increasingly, we notice that the Confirmation Letters, Monitoring Visit Reports, and Follow-Up Letters have discrepancies. This may be simple date inconsistencies, or critical data credibility issues. It is important that the monitor be aware of the importance of these issues in the review of study documentation. This module will provide some practical solutions to addressing document deficiencies as well as provide a practical understanding of how these documents provide evidence for the regulated activities of the investigator and the sponsor.

September 8, 2014

Barnett International

Cases in Advanced GCP: A Problem-Solving Practicum

9:00 AM - 12:00 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.

September 9, 2014

Barnett International

Quality by Design: A Lean Six Sigma Approach to Risk-Based Monitoring

9:30 AM - 11:00 AM Eastern

Monitoring consumes 30-60% of an operational budget for clinical trials or clinical programs. To sustain growth and reinvest in innovation, sponsors must find viable alternatives to reduce the resource burn, as well as create efficient and effective solutions to increase regulatory compliance, data integrity, and patient safety. By utilizing the combined toolboxes of Lean Six Sigma (LSS) + Quality by Design (QbD), sponsors can continue to invest in innovative products while producing customer-centric/efficient operational processes that are highly adaptable, constantly reproducible, and consume fewer resources. LSS + QbD provides CRAs and other risk-based monitoring staff with an arsenal of analytical tools to conduct fewer on site monitoring visits yet monitor the site more effectively and in real-time.

September 9, 2014

Barnett International

Data Management: Key Regulations Impacting the Role of the Clinical Data Manager

9:30 AM - 11:00 AM Eastern

In conducting clinical research, there are some specific regulations that directly impact the discipline of Clinical Data Management (CDM). 21 CFR Part 11 includes mandatory regulations that govern clinical trials data. It requires a system in which electronic records and signatures are trustworthy, reliable, and secure; electronic signatures that are equivalent to paper records and handwritten signatures executed on paper; a system that discerns invalid or altered records; and signatures that are linked to an electronic record.

September 10, 2014

Barnett International

Establishing a Risk Management Framework for Clinical Trial Conduct and Oversight

1:00 PM - 2:30 PM 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."

September 11, 2014

Barnett International

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

9:30 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.