The ORA serves as a central resource to encourage, facilitate, support and oversee research with expert staff dedicated to ensuring compliance with federal regulations, sponsor requirements, and clinic policies. Lahey’s ORA, under the direction of Antonia Holway, PhD, is comprised of a diverse group of experienced administrative and clinical professionals consisting of IRB Administrators, Research Study Coordinators, Clinical Research Associates and Specialists, Research Administrative Assistants, Research Financial Analysts and a Quality and Audit team.
IRB Administrators work closely with Lahey Clinic Inc.’s Institutional Review Board (IRB) to review and monitor human subject research taking place at Lahey Hospital & Medical Center. In 2013 ~1300 submissions were made to the IRB. This averages about 100 submissions a month that need to be reviewed, corrected and processed for IRB committee approval. With ~300 ongoing clinical trials at any given time and 1000 new patients consented annually, the IRB administrators perform under tight deadlines all the while ensuring that all research is in compliance with state and federal regulations and clinic policies.
The Research Finance team is responsible for negotiating the budgets and contracts for all sponsored research studies. This complex task includes assuring appropriate legal review of study documents, as well as reviewing all agreements for compliance with institutional and regulatory policies. Additionally this team oversees research patient billing and federal grants management.
When the work of the IRB and finance groups are complete the Research Study Coordinators, Clinical Research Associates and Clinical Research Specialists take over. This group represents the face of research at Lahey interacting with research study subjects and ensuring that their day to day experience is the best it can be. Their duties include explaining research studies to new patients, following patients during their study participation and making sure that the study protocol is followed.
Finally, the Research Quality team provides general quality oversight to clinical trials conducted at Lahey Hospital & Medical Center and its affiliated sites. This team not only identifies and addresses quality and compliance issues with research throughout our institution, but also provides education and reference materials, support and training to all Lahey colleagues engaged in clinical research activities.
For more information on Research Administration and the services provided, please call our office at 781-744-8027