| |
STEVE PECK
Director, Operations |
 Mr. Peck brings to Qualia an extensive background in clinical operations gained through 14 years of experience in the CRO industry conducting clinical trials to meet the needs of the global pharmaceutical and biotech industries. Having most recently directed clinical operations for a leading provider of phase 1 contract research, he understands the importance our clients place on defect free execution and on-time performance. Steve will use his knowledge and expertise leading the Qualia operations team to ensure continuous improvement and client satisfaction while maintaining best practices in quality, compliance and efficiencies. |
| |
KIM GROTHEER, RN
Associate Director, Clinical Operations |
Kim is a Registered Nurse with an Associates Degree in Nursing. She has over six years of experience conducting clinical trials, with broad based knowledge in the areas of oncology, endocrinology, rheumatology and neurology. In her years of experience working on a diverse range of studies, she has a proven track record of demonstrating excellence in the service provided to her clients.
|
| |
ERIN HEFNER, MS, CCRC
Associate Director, Clinical Operations |
| Erin attended Nebraska Wesleyan University where she earned her M.S. degree in forensic Science with a pathology emphasis. She is a Certified Clinical Research Coordinator, with over 3 years of Study Management experience in Phase I research, having managed studies in a variety of therapeutic areas including neurologic, cardiovascular, respiratory, gastrointestinal and general health. Additionally, Erin has an extensive medical background in the area of pathology and histology prior to coming to the clinical research industry. |
| |
MONA KALIM, MS
Project Manager |
 Mona is a co-founder for Qualia Omaha and initially managed the business functions for the Omaha clinic, including vendor relationships, human resource activities, clinic design/setup, and benefits coordination. She is currently working as a Project Manager at Qualia for dynamic and fast-paced sponsors with whom Qualia has strategic alliances. She manages all aspect of the clients business from study design to study reports.
She has an extensive and varied business background, including working as a Programmer/Systems Analyst, and Business Analyst for some of the world's top Fortune 500 companies. Mona brings over 18 years of corporate experience and works with clients to develop strategies that will make them industry leaders.
Mona holds a Masters Degree in Computer Science and Information Systems, and she also holds a Bachelor of Arts degree from the University of Calgary (double major in MIS and Accounting). |
| |
MARK LEWALLEN
Quality Assurance Manager |
 Mark focuses on the compliance and effectiveness of clinical and administrative functions while working directly with study sponsors to ensure quality—both in terms of accurate data and record management. Lewallen applies his expertise to activities of all clinical and administrative staff, and plays an active role in project and process development activities.
With more than 11 years of experience in Regulatory and Compliance facilitation of the medical industry, Lewallen has contributed his management and compliance skills to clinical research, medical device manufacturing and pharmaceutical source component production; developing effective capabilities in Quality Control, Quality Assurance, Project Management and Quality Management System Implementation. Mark’s background allows him to take ‘best practices and concepts’ and make them a reality at Qualia. This provides a solid foundation of excellence and continual improvement that will serve to facilitate successes for our organization as well as our clients. |
| |
NICOLE MITCHELL, RN, BSN
Clinic Manager |
 Nicole received her bachelor's degree in Nursing from Clarkson College in Omaha, NE. She is certified in Basic Life Support and Advanced Cardiac Life Support. Nicole brings her knowledge from various medical environments to Qualia. She is also a recipient of the Qualian Award of Excellence. |
| |
HOLLY BAKER
Manager, Participant Recruitment & Marketing |
 Holly graduated from the University of Nebraska at Lincoln with a Bachelor of Science degree in Marketing with an Advertising emphasis. Prior to joining Qualia, she led marketing efforts for a financial institution and a national gift card provider. Her strong background in Advertising and Campaign Management has prepared her well to lead Qualia’s participant recruitment efforts.
In addition to overseeing the on-site Recruitment Call Center team, she manages Qualia's Advertising and Outreach initiatives, both study specific as well as generic awareness to keep Qualia top-of-mind to potential participants. Holly also spearheads Qualia’s corporate marketing efforts globally. She is responsible for developing industry specific marketing campaigns and trade show plans, and conceptualizing BD selling tools.
|
| |
DAMIEN FOSTER
Manager, Screening & Admissions |
 Damien earned a B.S. in Biology from Midland Lutheran College in Fremont, Nebraska. He came to Qualia with a wealth of experience in instrumentation and bioanalytical research. He helped start the Clinical Services department of his previous company, and contributed significantly to the growth of the company as the Associate Lab Manager. He has also performed field technical support. These roles allowed him to work extensively with all levels of contacts at client organizations, preparing him for superior project leadership. |
| |
SHON LOGUE
Project Manager |
 Shon brings a solid scientific strength to Qualia. Receiving his degree in Cell and Molecular Biology, he has approximately ten years experience within the pharmaceutical industry at multiple CROs, working extensively in Research and Development, Validation, and Sample Analysis.
Shon began his career at Qualia by laying the foundation for the Quality Control Department. He now performs a myriad of vital functions, including generating and implementing procedures in the Sample Processing Laboratory and training the staff, Project Management, and assists in the creation of Qualia’s clinical laboratory. |
| |
JAMES HOFF, MD
Principal Investigator |
 Dr. Hoff, a medical graduate from the University of Tennessee, Memphis, brings to Qualia a conscientiously applied approach to ensuring full and total compliance of FDA clinical research standards and Good Clinical Practices as a Principal Investigator of Phase I studies. He is a Board Certified Diplomate of the American Board of Family Medicine, and is a Fellow of the American Academy of Family Physicians. Professional affiliation includes active membership in the American Medical Association. He has extensive and broad-based clinical experience in physical examination, clinical evaluation, treatment, and safety. He routinely reviews, evaluates, and interprets clinical laboratory assessments and ECG’s, and assists with developing study related protocols and content. He also examines to interpret and ensure compliance with protocols, with consistently high quality work product. Through monitoring and observation during clinical trials, he evaluates and assesses trends and discrepancies for consistency and relevance of the observed patterns, leading to timely understanding and corrective resolution. |
| |
RACHEL HUGGINS
Clincal Study Manager |
 Rachel received a B.A. in Psychology from the University of Nebraska, Lincoln. Prior to joining Qualia, she spent six years in psychological research and administration of neuropsychological tests. She is well versed in the administration of standardized assessments. In her most recent placement, she played a key role in the project management of an NIMH funded grant. Rachel has an excellent balance of experience in neuropsychological assessment administration and project management which makes her an excellent member to our study management team. |
| |
JULIE MARVIN, MS
Clinical Study Manager |
 Julie has a Master’s degree in Immunology from Thomas Jefferson University in Philadelphia. She has worked at multiple GMP/GLP facilities in pre-clinical research, and gained additional experience working at ICON clinical research as a clinical research associate. This allowed Julie to hit the ground running at Qualia. She joined Qualia's Quality Assurance group as a Quality Control Specialist and was promoted to Clinical Study Manager in March of 2008. |
| |
LISA HART
Clinical Study Manager |
 Lisa Hart received her bachelor’s degree in biology from the College of Charleston in Charleston, South Carolina. Prior to joining Qualia Clinical Services, she was a Laboratory Coordinator for a clinical and anatomic reference laboratory. Her background in laboratory testing, quality assurance and management of multiple departments has prepared her for responsibilities of clinical study management. |
| |
MELISSA KMENT
Clinical Study Manager |
 Melissa is a graduate of Metropolitan Community College in Omaha, NE where she received a Certificate of Achievement in Practical Nursing as well as an Associate of Science Degree in Nursing and Liberal Arts. Prior to joining team Qualia, Melissa worked in various healthcare settings including: Long Term Care, Medical/Surgical, and Telemetry. Throughout her career here at Qualia Clinical Services, she has held positions as a Clinical Nurse Coordinator, Special Population Nurse Coordinator, and most recently as a Clinical Study Manager. She is also a recipient of the Qualian Award of Excellence. Her background knowledge and involvement in the various stages of the many clinical trials completed here at Qualia makes her a great addition to the Study Management team. |
| |
ZORANA VOJNOVIC, PMP
Clinical Study Manager |
 Zorana is a Certified Project Manager with 10 years project management experience at Mutual of Omaha, and most recently as a Clinical Study Coordinator at the University of Nebraska Medical Center. Zorana earned a Bachelor’s degree from the University of Nebraska at Omaha and Juris Doctor’s degree from Law School in Sarajevo. |
|
