Compliance Leadership Team

Celine M. Clive, President, has more than 30 years experience in diverse areas of the drug development process, including positions in pharmaceutical companies and CROs. She has assisted numerous clients in the development of customized SOPs for their companies and institutions. She has developed and delivered orientation and training programs on a wide variety of topics. In addition, Ms. Clive performs Good Clinical Practices quality assurance audits for Sponsors, CROs, study site personnel, and IRBs. She was an alternate member of The Copernicus Group IRB. Ms. Clive is the former President of North Carolina Regulatory Affairs Forum and is a member of the Associates of Clinical Research Professionals, the Drug Information Association, and other professional societies. Ms. Clive has a Bachelor of Science degree in Biology from Wilson College in Chambersburg, PA and a Master's degree in Business Administration from Meredith College in Raleigh, NC.

Rosanne K. Sylvia-Heeter, Director of Good Manufacturing Practice Compliance, has over 30 years of quality assurance and compliance (GLP, GCP, CGMP), experience with Active Pharmaceutical Ingredients (APIs), Clinical Research Materials, and Finished Product. During her career, she has been responsible for developing global quality systems and preparing both domestic and international facilities for FDA Pre-approval Inspections (PAIs). Ms. Sylvia-Heeter has interacted with the FDA at both the Headquarters and District levels. She has prepared numerous training sessions for staff concerning Research and Finished Product. She has held positions as Compliance Manager, Quality Assurance Manager, and Global Director at major research-based and generic pharmaceutical companies and consulting firms. Her memberships include American Society of Quality, Regulatory Affairs Professional Society, and the North Carolina Regulatory Affairs Forum. Ms. Sylvia-Heeter holds a Bachelor of Science degree in Biology from Loyola University in Chicago.

Drug Information Association (DIA)

Associates of Clinical Research Professionals (ACRP)

North Carolina Chapter of the Society of Quality Assurance (NCCSQA)

Society of Quality Assurance (SQA)

Society of Clinical Research Associates (SoCRA)

North Carolina Pharmaceutical Discussion Forum (NCRAF)

American Society for Quality (ASQ)

American Medical Writers Association (AMWA)

Karen S. Sargent, Senior GCP Auditor, has more than 20 years experience in product development from the perspectives of the Sponsor, Investigative Site and Contract Research Organization (CRO). Ms. Sargent has extensive work experience in the pharmaceutical and medical device industries. Her work includes product safety and efficacy trials, pharmacoeconomic studies and consumer behaviors and preferences. She has performed domestic and international audits of both pharmaceutical and medical device sponsors, clinical sites, Institutional Review Boards, and vendor qualification assessments. In addition to FDA/ICH audits, Ms. Sargent has performed due diligence risk-assessment audits for acquisitions and mergers.

Ms. Sargent has published books, articles, and developed and taught training courses for clinical investigators, clinical research coordinators, monitors and quality auditors. She continues to be a frequent guest lecturer at several universities. Ms. Sargent has a Bachelor of Science degree in Healthcare Management from Rutgers University and is a graduate of the Nuclear Medicine program of Duke University and the Radiologic Technology program of Morehead State University. She holds ARRT and NMTCB certifications in radiology technology and nuclear medicine respectively.

Rita Griffin, Director of Good Clinical Practices Compliance, has 24 years of clinical research experience, including positions in both pharmaceutical companies and CROs. She started her career in 1985 as a Clinical Research Associate, and then progressed to Clinical Research Manager, and Director of Quality, Process and Training. Her experiences include the performance of all monitoring activities for Phase I-IV studies and the management of both domestic and international clinical trials. Ms. Griffin assumed various roles and responsibilities, including the development of a global compliance quality system, the development and implementation of global and regional educational strategies to ensure worldwide practice, and the direction of process improvement initiatives. Ms. Griffin is a member of the Drug Information Association and has a Bachelor’s degree in Health Sciences from the University of Massachusetts in Amherst, MA.

Karen L. Harrison, Project Manager, has over 35 years of experience in diverse areas of the drug development process, mainly in the pharmaceutical industry and over 10 years of experience in Good Clinical Practices. She has worked at the bench level testing antibiotics and in the development of radioimmunoassays. Her clinical experience started in the conduct of clinical trials for product line extensions. She was instrumental in the consolidation of domestic and international clinical trials for a major pharmaceutical company to provide coordination of development procedures to obtain worldwide registrations.

Ms. Harrison’s extensive experience and knowledge of the pharmaceutical industry was invaluable when she took the position of a Product Liability Specialist and became a part of the legal litigation team. After this interesting era in her career, she joined the Clinical Quality Assurance area. While in the GCP area, she audited clinical sites and company operations throughout the world. She implemented procedures for clinical document review and tracking; managed worldwide regulatory agency inspections of clinical trial investigators; managed potential misconduct and fraud cases; developed procedures for major internal clinical audits; and provided leadership and mentoring for the GCP staff. She has presented the principals of GCP at domestic and international investigator meetings. She received her Bachelor of Science degree in Medical Technology from Western Michigan University, in Kalamazoo, Michigan.

Karen Bernard, Operations Manager has 30 years of diverse business experience. During her career Ms. Bernard worked at IBM where she developed software, designed system architecture, and managed software development, architecture, testing, and project consulting teams. Subsequently, she has held positions as a management consultant, business analyst, trainer, office manager, small business owner, and online university professor for Capella University. Ms. Bernard holds a Bachelor of Science Degree in Mathematics from Bemidji State University in Bemidji, MN and a Masters of Business Administration degree from the Kenan-Flagler Business School at UNC Chapel Hill, NC.

Laurie Meehan, Internal Project Manager, is an education and training professional with 22 years of experience in both academic and corporate settings. She is an adjunct faculty member at Immaculata University, teaching math and computer science classes to traditionally-aged students, as well as to adult learners. Prior to her academic work, Ms. Meehan worked in the telecommunications industry for 15 years at Bellcore and Telcordia Technologies. There, she developed course curricula, and delivered technical training and consulting on the use, maintenance, and positioning of telecommunications services. Her systems engineering work includes designing interfaces between network elements in the public telephone system and developing requirements for Voice over IP applications. Ms. Meehan holds a Bachelor of Arts degree in Computer Science from La Salle University and a Master’s degree in Computer Science from Drexel University.