Fomat Medical Research Work Values

Daily Duties at Fomat Medical Research:

 Serve as a business development representative for a Site Management Organization, providing site-level support to CROs and pharmaceutical companies.  Establish professional relationships with Eli Lilly, IQVIA, Genentech.  Secured contract with IQVIA to work as the preferred SMO in California and Florida.  Manage and oversee the conduct of 10+ Phase II-III clinical studies. Therapeutic areas include: gastrointestinal (Chron’s Disease, Ulcerative Colitis), oncology (hepatocellular carcinoma), and dermatology (atopic dermatitis) in infants  Work with the largest network of gastroenterologists in California, Insite Digestive Health Care to initiate and run studies. Assisting in the recruitment of sites for studies:  Utilizing Insite´s patient database, targeting potential-high enrolling sites  Leading site visits with potential high-enrolling investigators to build interest in clinical research  Helped to develop a ‘one-sheet’ summarizing inclusion/exclusion criteria and schedule of assessments as an introduction for the investigator  Overseeing aspects of site initiation: feasibility assessments completion in forty-eight hours, conducting pre-selection visits and site selection visits, participating in PI protocol training presentations, collecting and signing of CDAs and supporting financial team with clinical research agreements /contracts and budgets  Collection of regulatory documents from sites to support IRB submission and ensure compliance with Good Clinical Practice (GCP), including Investigator CVs, Medical Licenses, GCP training certificates, Financial Disclosures, 1572s, Local Lab Normal Values and Certifications  Oversee CRA monitor visits to sites  Expertise with Clinical Research.IO an electronic clinical trial management system used to archive site regulatory documents, subject information tracking, subject scheduling, and site payment tracking

What they like about Fomat Medical Research:

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

Tags

Management, Budgeting, Cash Flow, Cash Flow Analysis, Clusters, Financial, Fixed Assets, Inventory, Valuations, Working Capital, clinical research, regulatory documents, Patient Recruitment, project management, JDE, CRIO, GCP, Excel, Power Point

Skills

Audits, Budgeting, Internal Controls, Relationship Management , Strategic Planning, Process Improvement, Business Development, Negotiations, Procurement / Purchasing, Vendor Relations, Ops Management, Global Cultural Competence , Team Leadership / Motivation , Global Cultural Awareness, Business Development , Clinical Research, Patient Recruitment

These are some of the questions we asked our climbers about their experiences with Fomat Medical Research: