Clinical Site Management

Clinical Site Coordinator/Manager Workshop - GCP for Coordinators, Research Associates, Study Nurses, and Site Managers

Dates, Locations, Contact Information, Fees, and Credit Hours New Canada Travel Passport Requirement (PDF) Goal Objective Learning Objectives Workshop Faculty Workshop Agenda Online Registration Form (Credit Card) Workshop Registration Form (PDF)

Dates, Locations, Contact Information, Fees, and Credit Hours

June 5 and 6, 2008 Delta Chelsea 33 Gerard Street Toronto, ON M5G 1Z4 Phone: 416.595.1975 Fax: 416.585.4362 SoCRA’s reduced room rate of $189 CAD plus taxes is available until four weeks before the conference or until the room block is filled.
October 23 and 24, 2008 Hotel Albuquerque at Old Town 800 Rio Grand Blvd NW Albuquerque, NM 87104 Phone: 505.843.6300 Fax: 505.842.8426 SoCRA’s reduced room rate of $135 USD plus taxes is available until four weeks before the conference or until the room block is filled.

Fees

SoCRA member - $ 575 - non-member - $650

Non-member fee includes membership for one year.

Credit Hours

Continuing Education Credit Hours
SoCRA designates this educational activity for a maximum of 14 Continuing Education Credit Hours for SoCRA CE, Nurse CNE, and Physician Category 1 CME.

Accreditation Statements:

• CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
• CNE for Nurses: This continuing nursing education activity was approved by the PA State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. ANCC/PSNA Provider Reference Number: 069-1-A-07

SoCRA Course Series: 600

The CCRP Certification Examination is offered throughout the year.
Your CCRP Certification Examination Registration materials must be received by the SoCRA administrative office six weeks prior to the exam date.

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Goal

The Society of Clinical Research Associates (SoCRA) recognizes the continuing need for education for Clinical Research Professionals responsible for the activities at the research site or institution. The purpose of this workshop is to assist Coordinators, Research Associates, Study Nurses, and Site Managers in improving their skills and their understanding of the responsibilities of the Clinical Research Site. This program is designed to address all of the functions of the research site related to the Good Clinical Practices as delineated by the U.S. Code of Federal Regulations and the guidelines supported by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH Guidelines).

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Objective

The goal will be accomplished through lecture and practical application facilitated by clinical research professionals with a combined industry experience of more than 20 years. Information will be presented and discussed regarding administration of clinical trials according to FDA Regulations and International Conference on Harmonization (ICH) guidelines as well as practical procedures and site / sponsor / CRO relationships.

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Learning Objectives

Upon completion of the workshop, the attendee should be able to:

• Discuss aspects of clinical trials that are governed by regulations and guidelines.
• Describe how essential documents permit evaluation of the conduct of a trial and the quality of the data produced.
• Discuss the elements of the Informed Consent Form, the ethical principals originating in the Declaration of Helsinki, the various aspects of the informed consent process, and those special considerations that may impact the process.
• Describe the various aspects of human research protections including the ICH definitions of AEs (adverse events) and SAEs (serious adverse events) and describe the reporting requirements common to all sponsors and IRBs/IECs.
• Discuss the role of the Study Coordinator including: Submitting a protocol to the IRB; Setting up local procedures; Source documentation management and control; and Working relations with Sponsors.
• Discuss the rationale and issues surrounding the monitoring visit and the audit process both from a site, a sponsor and a regulatory perspective.
• Discuss the philosophy and rationale for the development and implementation of Standard Operating Procedures.

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Workshop Faculty

Course Leader - Helen R. Darwin, CCRP

Course Leader - Jacqueline Busheikin, RN

Jacqueline Busheikin, RN, CCRP, is President of JANA Research Corporation, an independent clinical research consulting/monitoring organization established in 2001. She is a registered nurse and had been working in the field of clinical trials since 1989 as a study coordinator - specializing in Mental health, mainly schizophrenia, at the University of Calgary/Foothills Medical Centre. She was the first research coordinator at the Foothills Medical Centre and was responsible for establishing all standard operating procedures and for organizing the functioning of the unit. Ms. Busheikin has also presented numerous training and educational programs for site coordinators and clinical research monitors.

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Workshop Agenda

The Clinical Site Coordinator/Manager Workshop for Coordinators, Research Associates, Study Nurses, and Site Managers Workshop Agenda is available in Adobe PDF format, which can be viewed using the free-download of Adobe Acrobat Reader. (Click Here to Download this FREE software.)

Click Here to view/print the Workshop Agenda in Adobe PDF format.

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Online Registration Form (Credit Card)

Click HERE to register online for the Clinical Site Coordinator/Manager Workshop for Coordinators, Research Associates, Study Nurses, and Site Managers!

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Workshop Registration Form (PDF)

The Clinical Site Coordinator/Manager Workshop for Coordinators, Research Associates, Study Nurses, and Site Managers Workshop Registration form is available in Adobe PDF format, which can be viewed using the free-download of Adobe Acrobat Reader. (Click Here to Download this FREE software.)

Click Here to view/print the Workshop Registration Form in Adobe PDF.

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