Biomed/Biotech Special Interest Group  

�Incorporating Quality Oversight in Clinical Trial Management� 

To be presented by

Jo A. Collins, MS, CCPR

Manager

Quality Assurance Clinical Compliance

Ora, Inc.

Thursday, March 26, 2015

6:00 � 6:20 PM � Networking; Pizza/drink 

6:20 � 8:45 PM � Program 

8:45 � 9:00 PM � Door-prizes drawing; Networking

Online Registration site: https://asq509.org/ht/d/DoSurvey/i/35817

Open to Public � 

$5: non-ASQ members to cover pizza/drink cost; 

Free: ASQ members, veterans, senior citizens, past speakers, teachers, students, interns, residents, postdocs, FDA Commissioner�s Fellows, MJ-DC members, NTUAADC members, CAPA members, CKUAADC members, CCACC volunteers/employees, FAPAC members, CBA members, AAGEN members, Commissioned Corp officers, and current job-seekers. 

Location: Kelly�s Deli Conference Center, 7529 Standish Place, Rockville (Derwood, for GPS users), MD 20855

Registration Deadline: Please register by Thursday noon, March 26, 2015.  

Question: Please contact Dr. C.J. George Chang, Chair of Biomed/Biotech SIG, ASQ509; [email protected] or 240-793-8425 (cell).

Driving directions: By Cars: From I-270 (N or S bound): Take Exit 9A and exit from the FIRST right exit; turn left (east) onto Shady Grove Dr.; turn right (south) onto Rockville Pike (Route 355); turn left (east) onto East Gude Dr.; turn left (north) immediately onto Crabb�s Branch Dr.; turn left (west) immediately onto Standish Place. The first building on your right side is 7519 Standish Place; open parking). The venue is on the first floor of 7529 Building with its external entrance opposite to the left side of 7519 building main entrance. By Metro trains: Off from Red Line Shady Grove Station, and take RideOn Route 59 TOWARD ROCKVILLE and get off from �Calhoun Place� stop. Standish Place is next to the Bus stop. Our venue is within 2 min of walking distance from the stop.

Summary  

This presentation covers trends in clinical trial management and practical suggestions by incorporating quality oversight in clinical trial operations to mitigate risks and to ensure integrity in the conduct of human subject research.  Our discussions will also touch upon the shifting landscape in the pharmaceutical industry, contract research organizations, academic research institutions, and the research staff.  

Speaker�s Bio: 

Ms. Jo A. Collins is a certified clinical research professional (CCRP), and has nearly 16 years of research experience with career focus on clinical research, human research compliance (IRB), and quality assurance (QA).  Jo has held leadership positions in clinical research and IRB oversight, and is currently the Manager, Quality Assurance Clinical Compliance at Ora, Inc.  She performs protocol-specific GCP training at investigator meetings for pharmaceutical sponsors and biomedical monitoring at clinical investigator sites.  

Previously, Jo served as an Assistant Director, Johns Hopkins University Bloomberg School of Public Health, and a Human Subjects Protection Scientist in Research Compliance Program and a contractor for the Department of Defense in the human research compliance area.   Jo conducted GCP vendor audits for contract research organizations, drug distribution centers, IRBs; performed trend analyses and Quality Management Plan; and developed QA metrics in clinical trials.   She has held positions as Site Study Coordinator in oncology research and Deputy Project Manager (contractor) for the NIH National Cancer Center.  She worked as a Clinical Trials Specialist at Social Scientific Systems, Inc. where she worked on study start-up, investigator and site selection, protocol development, and medical writing for informed consents. She developed patient brochures and investigator educational material for a genomics repository study.  

Jo holds a Master�s of Science degree in Health Sciences Administration from Central Michigan University, and is currently working on her dissertation at Walden University in Business Administration and Leadership.  She serves as co-leader for the Society of Clinical Research Associates (SoCRA) National Capital Chapter since 2012.  

This Biomed/Biotech SIG event is cosponsored by the Monte Jade Science and Technology Association of Greater Washington (www.MonteJadeDC.org) and NTU Alumni Association at DC (www.ntuaadc.org).