ERIN ARCHARD, BA, CCRA
Erin comes to us from Massachusetts where she most recently served in the role of Principal Clinical Research Associate for Direct Flow Medical. Erin’s research experience encompasses over 8 years of the sponsor side of research as well as having had research coordinator roles in hospitals and private practice.
Erin is thrilled to join Tenet Leadership in partnering with CARE and the researchers in the Coastal Division to develop evidence based practice through clinical trials.
KELLY INSIGNARES, Ph. D.
Regulatory Affairs Compliance Officer
As the Regulatory Affairs Compliance Officer for CARE, she is responsible for spearheading compliance initiatives for clinical research taking place within the Tenet Florida Region and ensuring compliance with federal, state and institutional policies and procedures as they relate to clinical trials, the establishment and ongoing leadership of the CARE institutional review board, the initial review of clinical trial agreements, CMS submission, development of protocols, conducting assessments and responding to internal/external inspections as appropriate. In September of 2013, Dr. Insignares joined CARE in the role of Regulatory Affairs Compliance Officer for the Tenet Florida Region/CARE after serving eight years as the Executive Director of the Human Subject Research Protection Program at the University of Miami, where she was responsible for strategic operations initiatives across the enterprise including the creation of IRB policies and procedures, implementation of an electronic protocol submission system, successful restructuring of the IRB panels, leading successful inspections conducted by FDA and OHRP including drafting responses as appropriate, recruitment and retention of a high-performing regulatory and operational team, ensuring compliance with conflict of interest disclosures and management, increased revenue to support the clinical research infrastructure, implementing educational initiatives for investigators, IRB members and study teams, high quality, compliant and ethical reviews with a corresponding decrease in IRB submission turnaround times. She previously served as Executive Director of Human Resources for the University of Miami, Miller School of Medicine for two years where she was responsible for leading and directing the performance management and employee relations division which included establishing a grievance panel and responding promptly to sensitive personnel issues. Prior to that, Dr. Insignares held numerous roles within Faculty Professional Affairs with increasing leadership responsibility from the time she joined the University of Miami in 1993 through 2003.
Dr. Insignares holds a Ph.D. in Educational Leadership, an MBA in International Business and Human Resource Management, BBA in International Finance and Marketing and a Certificate in Health Administration. She is also certified in Healthcare Compliance (CHC), Healthcare Research Compliance (CHRC), as an IRB professional (CIP) and as an IRB manager (CIM). She is a member of PRIM&R/ARENA and HCCA.
She is located in the CARE administrative office at 7150 West 20th Ave, Suite 302, Hialeah, FL 33016
Office number: 786-639-1771
Fax number: 786-639-1970
LILIAN LIENS, DMS, CRC, RMA
Research Program Coordinator
As the Research Program Coordinator, Ms. Liens is responsible for coordinating all aspects of the Facility Review Committee (FRC) and other Regional Committees of the Center for Advanced Research Excellence (CARE). Ms. Liens is responsible for receiving, cataloguing, scheduling, and preparing all reports and materials submitted for FRC review. Lilian ensures that FRC projects (amendments, accrual notifications, and/or new studies) are completed for the intake review, and approval process. In March of 2013, Ms. Liens joined the CARE team after working at the University of Miami Medical Center, where she was a Clinical Research Coordinator for the Hematology-Oncology Division of the Sylvester Comprehensive Cancer Center, Clinical Research Services Department. She has over eleven years of clinical research experience in a multi-therapeutic setting. She holds an Associate Degree as a Diagnostic Medical Sonographer from National School of Technology and is a Registered Medical Assistant.
She is located in the CARE administrative office at 7150West 20th Ave, Suite 302, Hialeah, FL 33016
Office number: 786-639-1773
Fax number: 786-639-1970