Jim Simmer is President and Founder of Research Answers (www.researchanswers.net) , a clinical research consulting company that specializes in innovative solutions that benefit both Sponsor and Investigative Sites. He has over 13 years experience in clinical research and a MBA from Temple University. He built Research Answers on the foundation of customized, well planned, and dedicated delivery of services.Prior to founding Research Answers, Jim held diverse management positions for both pharma companies and research sites that has allowed him to develop a unique perspective. A frequent lecturer on advanced site management topics, he has been a presenter at the Association of Clinical Research Professionals (ACRP) Global Conference and a speaker for the Society of Clinical Research Associates (SoCRA).Our Evolution: Founded as Performance Research Site Management and Training in 2007, we changed our name to Research Answers in 2013 to better reflect our dual purpose of helping Sponsor and Site. We continue to build upon the same foundation of customized, well planned, and dedicated delivery of services, with which we started.Research Answers also has expanded its services for Sponsor and Site to include presentations and site development programs, and additional offerings are planned. Our new name is more reflective of the breadth and depth of our capabilities. That is, Research Answers provides innovative solutions for the research industry. Tell us how we can help you.

Co-creator and presenter of "Advanced Site Management: Finance and Productivity Enhanced Business Practices for Clinical Research Programs." The purpose of this workshop is to assist Physicians and Research Administrators in improving their skills and their understanding of the practical financial and business tasks related to clinical research. This workshop will focus on providing tools and techniques that the participants can immediately utilize to benefit their clinical research programs. Presentations include-Research Site Business Foundation- 6 pillars to success-Research Site Expense Management-Clinical Research Billing Compliance-Clinical Trial Budget Analysis and Negotiation-Risk Based Monitoring from the Site Perspective-Improving Physician Involvement in Researchhttps://www.socra.org/conferences-and-education/live-courses/advanced-site-management-finance-and-productivity-enhanced-business-practices-for-clinical-research-programs/program-information/

Responsible for the overall success of the Research Division of a Cardiology Practice of 17 physicians. Accomplishments include:Increased revenue (and associated enrollment) over 40% with only increasing expenses by less than 15% in a twelve-month periodAccurately forecasting revenue and expenses within 5%Increased the total number of active studies from 22 to over 35 in less than 18 monthsEducated medical staff and implementing policy change on Research legal issues such as mutual indemnification, and CMS billing policies.

Oversaw the medical, legal and business aspects of a research department at a 400 plus bed, tertiary care, Community/Academic Medical Center in suburban Philadelphia.Provided clinical research support in multiple therapeutic areas including cardiology, pulmonary, diabetes and oncology.Negotiated Clinical Study Agreements on behalf of the Medical Center to ensure that the Institution's exposure to liability is limited and budgets reimburse appropriately.

Assumed direct responsibility for the outcome of a phase 3b infectious disease clinical trial.Conducted initiation, follow-up, and close-out monitoring visits on an as needed basis.Instructed study sites on protocol compliance, suggest ideas to improve recruitment and subject evaluabilityProvided direction to the clinical team to ensure stated timelines are met.

Performed prestudy, initiation, interim and closeout monitoring visits to ensure Site compliance to the Protocol and GCPs. Provided informal and formal training to CRAs. Examined CRA monitor reports for accuracy and completeness.Monitored regulatory documents, patient status, personnel changes and other site activities.

Reviewed source documents and CRF, for accuracy and adherence to study protocol for a phase 4 cardiovascular study.Performed prestudy, initiation, interim and closeout monitoring visits to ensure Site compliance to the Protocol and GCPs.

Participated as a consultant on a Phase 3 retrospective breast cancer study. Responsibilities included review of source documents and captured data specified by study guidelines, entering data into the CRF, and resolving queries when needed.