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Clinical Project Manager (Part-Time Contract ) – Philadelphia, PA

Clinical Project Manager (Part-Time Contract ) – Philadelphia, PA A Clinical Project Manager (part time contract) is needed for a Contract Research Organization (CRO) to work in their office in the Philadelphia area. This position will report directly to the Chief Medical Officer and includes responsibility for coordinating and managing all aspects of clinical study […]

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Clinical Planning Manager Job/Senior CTM, Large Pharmaceutical

Sr. Clinical Planning Manager Large Pharma Client Needs Your Clinical Trial Expertise! A Clinical Planning Manager, capable of handling 12 teams with 25 members each of both internal and external members, is urgently needed by our client. You will use your 8 + years of industry experience to proactively identify potential pitfalls and steer the team around them. […]

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Regulatory Inspections and How to Manage Them

Regulatory Inspections and How to Manage Them You are Invited to an Evening Meeting Regulatory Inspections and How to Manage Them      Orange County Regulatory Affairs Discussion Group (OCRA)    Wednesday, November 5, 2014  5:30 – 9:00 pm 

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Precision Medicine: A Medical Miracle or Ethical Nightmare?

Precision  Medicine: A Medical Miracle or Ethical Nightmare? The Precision Medicine presentation will explore the concept of precision medicine and how it impacts the conduct of oncology clinical trials, regulatory guidance, subject recruitment, and the protection of human subjects participating in research. Learn to recognize the therapeutic misconception and how it impacts patient, caregiver and investigator/physician […]

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Reproducibility Crisis in Biomedical Research

The Reproducibility Crisis in Biomedical Research New quality practices developed by the ASQ FD&C Division could change the trend in the Reproducibility Crisis in Biomedical Research! “The productivity of modern drug development has been steadily

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Risk Management

Risk Management Orange County Regulatory Affairs Discussion Group Thursday, November 14, 2013 Location: Irvine Marriott 18000 Von Karman Irvine, CA  92612 949-553-0100  

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2013 Workshop - Marketing of FDA Regulated Products

2013 Workshop – Marketing of FDA Regulated Products FDA Centers, FDA Los Angeles District Office and the Orange County Regulatory Affairs Discussion Group Present The 16th Annual FDA-OCRA Educational Conference June 12-13, 2013 Irvine Marriott 18000 Von Karman Avenue, Irvine, CA 92612 (949) 553-0100 The FDA-OCRA Educational Conference is a unique event co-sponsored by the FDA and […]

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Building and Maintaining Quality in Clinical Trial Performance

Building and Maintaining Quality in Clinical Trial Performance FDA Inspections of Clinical Research Sites and Sponsors Building and Maintaining Quality in Clinical Trial Performance Wednesday, April 10, 2013 5:30 – 8:30 pm Location:    AMO Headquarters 1700 East St. Andrews Place Santa Ana, CA 92705-4933 Program Managers: Terrie Hopton, Manager, Business Development and Special Projects, Promedica International […]

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OCRA Supplements Update: What's on the Horizon in 2013

OCRA Supplements Update: What’s on the Horizon in 2013 Orange County Regulatory Affairs Discussion Group (OCRA) Wednesday, January 9, 2013 12:30 pm – 5:00 pm Location: Irvine Marriott 18000 Von Karman, Irvine, CA 92612 949-553-0100 Program Managers: Rogelio Rodriquez Cameron B. Smith, J.D., Sr. Director, World Wide Regulatory, Government & Industry Affairs and Intellectual Property, […]

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Quality in Performance Management

Quality in Performance Management Today’s economic climate and competitive marketplace demand peak performance from everyone involved, and each individual, from the mail room to the CEO,  has the ability to affect change and drive business results. Join Gary Urban, Executive Director of Operations at Rx Research Services Clinical Research Organization (RxRS CRO) and explore his […]

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