Upstate Medical University

SOCRA NYS Chapter On-Site Clinical Research and Regulations Program at The Lodge

Open to the Public - On-Site Clinical Research and Regulatory New York State SOCRA Chapter Program at The Lodge in Skaneateles Falls, NY
Friday, March 15, 2024
7:45 a.m. – 3:15 p.m.
Must register to attend. 
Catering Fee:  $43.00
Deadline to Register:  March 5, 2024  

REGISTRATION FORM

AGENDA: 

7:45 a.m. Sign-In, Continental Breakfast and Networking

8:15 a.m. Welcome and Introduction

8:20 – 9:20 Real World Evidence:  Being Creative & Innovative in Submissions (FDA acceptance and uses for submissions) Eric J. Fernandez, MD, Global Clinical Research Lead, Healthcare Systems & Technology (HST), Worldwide Medical, Baxter Healthcare Corporation

9:20 – 10:20 Developing a Training Program for Study Team Members Erinn McDowell, MS, CCRP, Cancer Center Clinical Trials Manager, Upstate Medical University

10:20 – 10:40 Beverage Break                                                 

10:40 – 11:20 Biobanking Project Andrew Brindle, Executive Vice President, Research and Development, Quadrant Biosciences

11:20 – 12:00 Research Registries and Repositories Nikki Mason, MS, CIP, Chief Compliance Officer for Research, HRPP Director, Upstate Medical University

12:00 – 1:00 Lunch and Networking 

1:00 – 1:45 Innovate Upstate: Re-Imagining an Academic Medical Center as a Regional Asset for Innovation and Entrepreneurship, David Amberg, Vice President for Research, Upstate Medical University

1:45 – 3:00 Networking Session Session Moderators:  Kylie Sands, Nikki Mason, Emily Spinner

In the next 15 minutes your task is to meet someone who has done the following:

  • Pediatric Research that involves a Minor Increase Over Minimal Risk
  • Exception from Informed Consent for Emergency Research
  • Expanded Access and/or Compassionate Care Treatment Protocol
  • Consenting process that involves a Legally Authorized Representative
  1. Brief discussion about the above topics from a regulatory and operational perspective.
  2. What is one thing your site/company/team does super well you are proud of?
  3. What is one area you are interested in but don’t know who to seek out for information?
  4. Research Study Enrollment Demographics

3:00 – 3:15                  Final Q&A

The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area.

This program will provide 5.7 hours of continuing education hours.

Program is in-person attendance only.  This program will not be recorded.

Please send completed On-site Registration Form by March 5th to: kylie.sands@rochesterregional.org   

As SOCRA Chapters are not allowed to accept any funds or payments, all catering fees must be paid directly to the catering vendor: 

  • Payment of the $ 43.00 catering fee is expected the day of the program. Please plan to pay by credit card or check. If paying by check – make checks payable to “Eurest Dining Services.” 
  • If you need to send your check in advance, checks payable to “Eurest Dining Services” can be mailed to: The Lodge Skaneateles, 4355 State Street Rd., Skaneateles Falls, NY 13153, Re:  SOCRA Chapter Program.
  • The Lodge Skaneateles requests we provide our final guest count at least ten calendar days prior to the date of Event. On-site registration form must be sent by March 5th to Kylie Sands at:   sands@rochesterregional.org